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CM-B

AND ANATOMIC PATHOLOGY EDUCATION PROGRAMS

SURVEYS 2013

Clinical Microscopy

PARTICIPANT SUMMARY
0.25 Hours of Self-Reported Training Available
This document is available on e-LAB Solutions™.
© 2013 College of American Pathologists. The College does not permit reproduction of any substantial
portion of the material in this Report without its written authorization. The College hereby authorizes
participants in the program to use the material in this Report solely for educational purposes within their
own institutions. The College prohibits use of the material in the Report — and any unauthorized use of the
College’s name or logo — in connection with promotional efforts by marketers of laboratory equipment,
reagents, materials, or services. Data from this program do not necessarily indicate the superiority or
inferiority of instruments, reagents, or other materials used by participating laboratories. Use of these data
to suggest such superiority or inferiority may be deceptive and misleading. The College will take all steps
open to it under the law to prevent unauthorized reproduction of substantial portions of the material in this
Report, deceptive use of any such material, and any unauthorized use of the College’s name or logo in
connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services.
TABLE OF CONTENTS
Program Update ........................................................................................................................................................ 1
Evaluation Criteria ..................................................................................................................................................... 2
CMP/CMP1 – Clinical Microscopy
Bilirubin .................................................................................................................................................................. 34
Bilirubin, IRIS iChemVELOCITY and iChem 100 (CMP1 only)............................................................................. 40
Blood or Hemoglobin ............................................................................................................................................. 42
Glucose ................................................................................................................................................................. 19
Ketones ................................................................................................................................................................. 26
Leukocyte Esterase ............................................................................................................................................... 49
Nitrite ..................................................................................................................................................................... 57
Osmolality ................................................................................................................................................................ 3
pH, Urine ............................................................................................................................................................... 10
Protein (Qualitative) ............................................................................................................................................... 13
Reducing Substance ............................................................................................................................................. 25
Specific Gravity........................................................................................................................................................ 7
Urobilinogen .......................................................................................................................................................... 60
Urine hCG................................................................................................................................................................ 4
Urine Sediment Photographs ................................................................................................................................ 63
Body Fluid Photographs ........................................................................................................................................ 67
Case Discussion: Pneumocystis in BAL ............................................................................................................... 73
CMMP – Clinical Microscopy Miscellaneous Photographs ...................................................................................... 75
OCB – Occult Blood.................................................................................................................................................. 81
GOCB – Gastric Occult Blood
Gastric Occult Blood .............................................................................................................................................. 82
Gastric pH.............................................................................................................................................................. 83
DSC – Dipstick Confirmatory
Bilirubin, Confirmatory ........................................................................................................................................... 84
Protein, Confirmatory ............................................................................................................................................ 84
Actions Laboratories Should Take when a PT Result is Not Graded ....................................................................... 85
Attestation of Participation for Self-Reported Training ............................................................................................. 86
HEMATOLOGY AND CLINICAL MICROSCOPY RESOURCE COMMITTEE
Joan E. Etzell, MD, FCAP, Chair
Sherrie L. Perkins, MD, PhD, FCAP, Vice Chair
Kyle T. Bradley, MD, MS, FCAP
David R. Czuchlewski, MD, FCAP
John L. Frater Jr., MD, FCAP
Tracy I. George, MD, FCAP
George M. Girgis, MT
Eric D. Hsi, MD, FCAP
David F. Keren, MD, FCAP
Martina Lefterova, MD, PhD

Jennifer L. Oliveira, MD, FCAP
Jay L. Patel, MD, FCAP
Janet Piscitelli, MD, FCAP
Kathryn A. Rizzo, DO, PhD, FCAP
Luke R. Shier, MD, FCAP
Anna K. Wong, MD, FCAP
David L. Zwick, MD, FCAP
Maria A. Proytcheva, MD, FCAP, Liaison
2013 CM-B
PARTICIPANT SUMMARY
Program Update

Don’t Miss Out on this Educational Opportunity!
With your participation in CAP’s Surveys programs, every member of your team can
take part in education activities: earn Continuing Education (CE) credits or receive
Self-Reported Training* at no additional charge.
This Survey mailing includes a Self-Reported Training activity. By reviewing the
discussion that begins on page 63, your laboratory staff can earn 0.25 education
hours that can be used towards fulfilling education and certification maintenance
requirements. For your convenience, a form has been included to document your
staff’s participation in the activity. See page 86.
*CAP Self-Reported Training activities do not offer CE credit, but can be used
towards fulfilling requirements for certification maintenance by agencies such as the
American Society of Clinical Pathology (ASCP). Please verify with your certifying
agency to determine your education requirements.

1
Evaluation Criteria

QUALITATIVE
For qualitative procedures in urinalysis, evaluation is based on participant consensus
by method and instrument. For each analyte, a minimum of two, but not more than four,
responses will be given a passing score. Analyte results graded “Good” performance
must have 80% participant consensus. Eighty percent participant consensus can be
determined by grouping the mode with the next one or two most frequent responses.
This group will be given “Good” performance. “Acceptable” performance will be given to
additional responses until a minimum of 90% of participant results are given a passing
score. In the case of a negative specimen, negative responses must constitute 90%
participant consensus. Specimens with results for one of more methods distributed
over both negative and positive responses (non-consensus) will not be evaluated.
Specimens for which there is greater than 90% of participant responses distributed
over more than four responses will be graded as “Non-consensus”.
Analyte
Bilirubin, Confirmatory
Gastric Occult Blood
Gastric pH
Nitrate
Occult Blood
Protein, Confirmatory
Urine hCG
QUANTITATIVE
Analyte
Gastric pH
Osmolality
Specific Gravity

Evaluation Criteria
80% overall participant consensus/intended response
80% overall participant consensus/intended response
80% overall participant consensus/intended response
80% overall participant consensus/intended response
80% overall participant consensus/intended response
80% overall participant consensus/intended response
80% overall participant consensus/intended response

Target Value
Peer Group Mean
Peer Group Mean
Peer Group Mean

Evaluation Criteria
 3 SD
 3 SD
 2 SD or 0.010, whichever is greater

Low and high values shown in the Participant Summary indicate the range of values
reported.
Low and high limits of acceptability are shown on the evaluation report.
Data are not included for methods used by fewer than 10 laboratories.

PHOTOGRAPHS
Photographs are evaluated for CAP purposes according to 80% or greater consensus
of either referees or participant laboratories. "Good" performance is given for the
intended response. Additionally, the Hematology and Clinical Microscopy Resource
Committee may, at its discretion, grant either "good" or "acceptable" performance for
other equivalent responses.
To provide a timely evaluation of your results, statistics presented in this Participant
Summary reflect a minimum of 80% of participant enrollment. In the event a result is
not graded, a numeric code will appear next to your result. A definition of the code will
appear on the first page of the evaluation. Please see “Actions Laboratories Should
Take when a PT Result is Not Graded” on page 85.
2
No.
Labs

Mean

S.D.

C.V.

CM-14

Advanced Instruments
ARKRAY
Fiske
Precision Systems

997
50
84
25

866.4
862.8
868.1
857.5

4.8
3.7
6.3
7.9

0.6
0.4
0.7
0.9

CM-15

Advanced Instruments
ARKRAY
Fiske
Precision Systems

1001
49
86
25

763.7
763.0
765.2
758.2

4.0
3.1
4.7
5.4

0.5
0.4
0.6
0.7

CM-16

Osmolality - mOsm/kg (mmol/kg)

Advanced Instruments
ARKRAY
Fiske
Precision Systems

1001
51
85
25

418.0
419.5
420.2
414.0

3.7
3.1
4.5
7.1

0.9
0.7
1.1
1.7

3
Urine hCG
The hCG level was intended to be positive.

CM-14

Manufacturer

Manufacturer's Stated
Sensitivity Level
mIU/mL

Abbott TestPack Plus Combo w/ or w/out OBC
Acceava Combo II
ACON One Step (urine only)
Alere hCG Cassette (20) (Acceava)
Alere hCG Cassette (25) (Clearview)
Alere hCG Combo Cassette (20/10)
Alere hCG Combo Cassette (25) (Clearview)
Beckman Coulter ICON 20
Beckman Coulter ICON 25
Cardinal Health SP Brand Cassette
Cardinal Health SP Brand Combo
Cen-Med Elite Plus One Step hCG
Clearview hCG Combo II
Eiken
Meridian ImmunoCard STAT
Polymedco Poly stat (serum/urine)
Quidel QuickVue One-Step Combo
Quidel QuickVue One-Step Urine
Quidel QuickVue+ One-Step Combo
Ramco Quik-Trak Combi Test (serum/urine)
Randox Direct
SA Scientific (SAS) Ultra
SA Scientific (serum/urine)
Sekisui OSOM
Sekisui OSOM Combo
Siemens Clinitek Status
Stanbio QuPID
Stanbio QuPID Plus
Stanbio QuPID Plus E.R.
Stanbio True 20 Plus
Sure-Vue (urine only)
Sure-Vue (serum/urine)
Sure-Vue STAT (serum/urine)
Technologist Choice (serum/urine)
Other and Methods with <10 responses

25
20
25
20
25
25
20
-

4

Negative

Positive

2
1
1
1
1
1
1
-

11
16
37
17
26
72
50
125
354
111
628
89
45
10
48
34
431
217
471
10
14
16
19
34
334
29
18
51
15
36
84
306
374
16
357
Urine hCG
The hCG level was intended to be positive.

CM-15

Manufacturer

Manufacturer's Stated
Sensitivity Level
mIU/mL

Abbott TestPack Plus Combo w/ or w/out OBC
Acceava Combo II
ACON One Step (urine only)
Alere hCG Cassette (20) (Acceava)
Alere hCG Cassette (25) (Clearview)
Alere hCG Combo Cassette (20/10)
Alere hCG Combo Cassette (25) (Clearview)
Beckman Coulter ICON 20
Beckman Coulter ICON 25
Cardinal Health SP Brand Cassette
Cardinal Health SP Brand Combo
Cen-Med Elite Plus One Step hCG
Clearview hCG Combo II
Eiken
Meridian ImmunoCard STAT
Polymedco Poly stat (serum/urine)
Quidel QuickVue One-Step Combo
Quidel QuickVue One-Step Urine
Quidel QuickVue+ One-Step Combo
Ramco Quik-Trak Combi Test (serum/urine)
Randox Direct
SA Scientific (SAS) Ultra
SA Scientific (serum/urine)
Sekisui OSOM
Sekisui OSOM Combo
Siemens Clinitek Status
Stanbio QuPID
Stanbio QuPID Plus
Stanbio QuPID Plus E.R.
Stanbio True 20 Plus
Sure-Vue (urine only)
Sure-Vue (serum/urine)
Sure-Vue STAT (serum/urine)
Technologist Choice (serum/urine)
Other and Methods with <10 responses

25
20
25
20
25
25
20
-

5

Negative

Positive

1
2
1
1
1
1
2

11
16
37
17
26
72
50
126
353
111
627
89
45
10
48
34
430
216
473
10
14
16
19
34
334
29
18
51
15
36
85
306
375
16
355
Urine hCG
The hCG level was intended to be positive.

CM-16

Manufacturer

Manufacturer's Stated
Sensitivity Level
mIU/mL

Abbott TestPack Plus Combo w/ or w/out OBC
Acceava Combo II
ACON One Step (urine only)
Alere hCG Cassette (20) (Acceava)
Alere hCG Cassette (25) (Clearview)
Alere hCG Combo Cassette (20/10)
Alere hCG Combo Cassette (25) (Clearview)
Beckman Coulter ICON 20
Beckman Coulter ICON 25
Cardinal Health SP Brand Cassette
Cardinal Health SP Brand Combo
Cen-Med Elite Plus One Step hCG
Clearview hCG Combo II
Eiken
Meridian ImmunoCard STAT
Polymedco Poly stat (serum/urine)
Quidel QuickVue One-Step Combo
Quidel QuickVue One-Step Urine
Quidel QuickVue+ One-Step Combo
Ramco Quik-Trak Combi Test (serum/urine)
Randox Direct
SA Scientific (SAS) Ultra
SA Scientific (serum/urine)
Sekisui OSOM
Sekisui OSOM Combo
Siemens Clinitek Status
Stanbio QuPID
Stanbio QuPID Plus
Stanbio QuPID Plus E.R.
Stanbio True 20 Plus
Sure-Vue (urine only)
Sure-Vue (serum/urine)
Sure-Vue STAT (serum/urine)
Technologist Choice (serum/urine)
Other and Methods with <10 responses

25
20
25
20
25
25
20
-

6

Negative

Positive

1
1
1
1
1
1
2

11
16
37
17
26
72
50
127
354
111
627
89
45
10
48
34
429
215
473
10
14
16
19
34
334
29
18
51
15
36
84
306
375
16
355
Specific Gravity
No.
Labs

CM-14

C.V.

1.0200
1.0200

0.0000
0.0000

0.0
0.0

1.0144

0.0012

0.1

11
10

1.0200
1.0200

0.0000
0.0000

0.0
0.0

10
10

1.0200
1.0200

0.0000
0.0000

0.0
0.0

12

1.0186

0.0017

0.2

74

1.0245

0.0015

0.1

199

1.0151

0.0007

0.1

28
11

1.0142
1.0144

0.0008
0.0022

0.1
0.2

171
11
38
210

1.0145
1.0190
1.0153
1.0174

0.0013
0.0010
0.0007
0.0011

0.1
0.1
0.1
0.1

232
25
239
51
85

1.0113
1.0128
1.0129
1.0115
1.0128

0.0022
0.0025
0.0027
0.0025
0.0031

0.2
0.3
0.3
0.2
0.3

117

1.0174

0.0009

0.1

518

1.0172

0.0015

0.1

12
27
903
18
162
180

Method/Instrument

S.D.

461

ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diag. Test Group Clarity Urocheck Reag. Strips
Diagnostic Test Group Clarity Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips (800-7212)
IRIS iChemVELOCITY
IRIS Mass Gravity Meter
ARKRAY/IRIS Aution Max/iQ200
IRIS iChemVELOCITY
Refractometer
ARKRAY/IRIS Aution Max/iQ200
Eiken US-3100R/3100Rplus
IRIS iChemVELOCITY
Visual
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Mean

10
10

Method/Instrument

1.0263
1.0259
1.0251
1.0175
1.0282
1.0215

0.0031
0.0046
0.0016
0.0016
0.0025
0.0039

0.3
0.5
0.2
0.2
0.2
0.4

Low

High

1.030
1.030
1.029
1.029

1.030
1.030
1.030
1.030

No. Labs Median

Greater-Than Values
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

37
43
347
639

7

1.030
1.030
1.030
1.030
Specific Gravity
No.
Labs

CM-15

C.V.

1.0205
1.0200

0.0015
0.0000

0.1
0.0

1.0122

0.0012

0.1

11
10

1.0200
1.0200

0.0000
0.0000

0.0
0.0

10
10

1.0200
1.0200

0.0000
0.0000

0.0
0.0

11

1.0154

0.0007

0.1

76

1.0191

0.0022

0.2

201

1.0133

0.0008

0.1

30
11

1.0119
1.0126

0.0012
0.0022

0.1
0.2

170
11
38
210

1.0121
1.0153
1.0133
1.0145

0.0011
0.0005
0.0007
0.0009

0.1
0.0
0.1
0.1

235
25
238
51
86

1.0133
1.0136
1.0131
1.0127
1.0080

0.0030
0.0023
0.0030
0.0032
0.0037

0.3
0.2
0.3
0.3
0.4

116

1.0145

0.0008

0.1

515

1.0150

0.0010

0.1

13
27
917
17
202
183

Method/Instrument

S.D.

466

ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diag. Test Group Clarity Urocheck Reag. Strips
Diagnostic Test Group Clarity Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips (800-7212)
IRIS iChemVELOCITY
IRIS Mass Gravity Meter
ARKRAY/IRIS Aution Max/iQ200
IRIS iChemVELOCITY
Refractometer
ARKRAY/IRIS Aution Max/iQ200
Eiken US-3100R/3100Rplus
IRIS iChemVELOCITY
Visual
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Mean

11
10

Method/Instrument

1.0269
1.0252
1.0250
1.0148
1.0276
1.0190

0.0025
0.0050
0.0001
0.0006
0.0027
0.0043

0.2
0.5
0.0
0.1
0.3
0.4

Low

High

1.030
1.030
1.030
1.029

1.030
1.030
1.030
1.030

No. Labs Median

Greater-Than Values
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

35
42
241
599

8

1.030
1.030
1.030
1.030
Specific Gravity
No.
Labs

CM-16

C.V.

1.0155
1.0150

0.0015
0.0000

0.1
0.0

1.0154

0.0014

0.1

11
10

1.0155
1.0150

0.0015
0.0000

0.1
0.0

10
10

1.0150
1.0150

0.0000
0.0000

0.0
0.0

12

1.0218

0.0013

0.1

76

1.0136

0.0025

0.2

201

1.0156

0.0008

0.1

32
11

1.0153
1.0152

0.0018
0.0021

0.2
0.2

169
11
37
208

1.0155
1.0218
1.0155
1.0200

0.0016
0.0009
0.0006
0.0009

0.2
0.1
0.1
0.1

233
25
238
52
86

1.0126
1.0144
1.0139
1.0129
1.0150

0.0026
0.0022
0.0026
0.0027
0.0020

0.3
0.2
0.3
0.3
0.2

116

1.0199

0.0008

0.1

503

1.0206

0.0010

0.1

50
68
1255
19
813
185

Method/Instrument

S.D.

463

ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diag. Test Group Clarity Urocheck Reag. Strips
Diagnostic Test Group Clarity Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips (800-7212)
IRIS iChemVELOCITY
IRIS Mass Gravity Meter
ARKRAY/IRIS Aution Max/iQ200
IRIS iChemVELOCITY
Refractometer
ARKRAY/IRIS Aution Max/iQ200
Eiken US-3100R/3100Rplus
IRIS iChemVELOCITY
Visual
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Mean

11
10

Method/Instrument

1.0243
1.0207
1.0211
1.0205
1.0235
1.0187

0.0020
0.0025
0.0021
0.0008
0.0024
0.0044

0.2
0.2
0.2
0.1
0.2
0.4

Low

High

1.025

1.030

No. Labs Median

Greater-Than Values
Siemens Reagent Strips
Siemens Clinitek Status

10
9

1.030
pH, Urine
≤3.5

4.0

4.5

5.0

5.5

6.0

6.5

7.0

-

-

-

-

-

-

-

10
10

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

7.5

8.0

8.5

≥9.0

-

-

-

-

674

6

-

-

-

8

3

-

-

-

-

-

-

11
10

-

-

-

-

-

-

-

10

-

-

-

-

-

-

-

-

10

-

-

-

-

-

-

-

-

-

24

5

-

-

-

-

-

-

-

-

-

84

-

1

-

-

-

-

-

-

-

4

-

260

-

-

-

-

-

-

-

-

-

-

1
-

242
26
252
55
101

1

1
-

-

-

-

-

-

-

-

-

-

126

-

-

-

-

-

-

-

-

-

-

-

543

1

-

-

-

-

-

-

-

-

1
1
1
1

1
20
1
2

33
75
1327
18
865
119

21
1
3
89

1
2

-

-

CM-14

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur*
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual**
Roche Urisys Cassette*
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

* Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5.
** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed.

10
pH, Urine
≤3.5

4.0

4.5

5.0

5.5

6.0

6.5

7.0

7.5

-

-

-

-

-

-

-

-

10
10

-

-

-

-

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

8.0

8.5

≥9.0

-

-

-

581

98

-

-

10

1

-

-

-

-

1
-

10
10

-

-

-

-

-

-

10

-

-

-

-

-

-

-

10

-

-

-

-

-

-

-

-

5

24

-

-

-

-

-

-

-

-

-

85

-

-

-

-

-

-

1

2

4

-

254

-

3

-

-

-

-

-

-

1
-

1
6
3

1
1
2

187
25
247
49
94

-

54
5
3

-

-

-

-

-

1

-

6

1

118

-

-

-

-

-

-

-

-

-

1

538

4

-

-

-

-

-

-

-

2
1
3

1
5

2
5
174
1
23
13

12
62
588
16
493
86

40
8
584
281
106

1
1
1
70
-

-

CM-15

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur*
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual**
Roche Urisys Cassette*
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

* Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5.
** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed.

11
pH, Urine
≤3.5
4.0

4.5

5.0

5.5

6.0

6.5

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

7.0

7.5

8.0

8.5

≥9.0

10
10

-

-

-

-

5

675

-

-

-

-

1

9

1

-

-

-

-

-

-

1
-

10
10

-

-

-

-

-

-

-

-

10

-

-

-

-

-

-

-

-

-

10

-

-

-

-

-

-

-

-

-

-

29

-

-

-

-

-

-

-

-

-

-

-

75

-

10

-

-

-

-

-

-

-

2

-

260

-

-

2

-

-

-

-

-

-

1
1

1
1
1
1

241
24
253
54
100

-

1
-

-

-

-

-

-

-

-

-

-

126

-

-

-

-

-

-

-

-

-

-

69

475

-

-

-

-

-

-

-

1

1
-

3
4

1
3
30
3
5
8

51
73
1315
15
863
190

2
8

2
2

-

1

CM-16

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur*
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual**
Roche Urisys Cassette*
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

* Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5.
** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed.

12
Protein – Qualitative, Method 1

CM-14

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative Trace

1+

2+

3+

4+

-

-

-

-

10
10

-

-

-

1

42

204

-

-

-

-

3

5

2

-

-

-

-

11
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

13

15

-

-

-

1

25

-

-

-

-

5

87

1

1

-

1
1
-

1
3
1
10

105
38
9
73

53
13
1

-

-

-

1

27

4

-

-

-

1

208

18

1
-

2

1

2
125
1
16

20
18
333
15
371
110

4
10
1
21
49

13
Protein – Qualitative, Method 1

CM-15

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative Trace

1+

2+

3+

4+

-

-

-

-

10
10

-

1

-

1

243

1

1

-

-

-

8

2

-

-

-

-

1
-

10
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

1

27

-

-

-

-

4

22

-

-

-

-

86

7

-

1
-

-

1
1
-

27
18
1
38

80
51
13
47

24
8
-

-

-

-

16

14

2

-

-

-

12

209

5

1
-

-

1
1
3

7
425
2
5
45

15
18
38
14
368
114

3
3
20
16

14
Protein – Qualitative, Method 1

CM-16

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative Trace

1+

2+

3+

4+

-

-

-

-

10
10

-

-

-

-

2

236

9

-

-

-

-

3

7

-

-

-

-

11
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

7

21

-

-

-

-

26

-

-

-

-

3

89

1

-

-

-

1
1
7

107
32
8
77

62
14
1

-

1

-

-

25

6

-

-

-

1

179

46

1
1
1
-

1

2

1
12
2
19

21
18
442
13
371
93

4
13
2
19
63

15
Protein – Qualitative, Method 2

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

75
mg/dL
10-20 30-70 (Roche
Negative mg/dL mg/dL only)*

100-200
mg/dL

300-600
mg/dL

≥500
mg/dL
(IRIS
only)*

>600 or
≥1000
mg/dL

2

-

-

-

84

339

10

2

-

-

-

-

1

2

56

-

1

-

-

-

18

9

141

-

-

-

-

-

4
2
23
1
2

132
16
132
32
17

3
-

1
1

-

-

-

-

7

85

1

-

-

-

-

-

3

291

-

16

2
-

1
-

-

-

5
1
252
1
1

26
54
620
470
49

-

1
1
3
1
12

* Not appropriate for Roche Urisys 1100 users.
.

16
Protein – Qualitative, Method 2

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

75
mg/dL
10-20 30-70 (Roche
Negative mg/dL mg/dL only)*

100-200
mg/dL

300-600
mg/dL

≥500
mg/dL
(IRIS
only)*

>600 or
≥1000
mg/dL

1

-

1

-

429

6

-

-

-

-

-

-

8

2

49

-

2

-

1

-

144

1

21

-

-

-

1

-

43
11
83
6
6

93
7
73
27
12

2
-

1
1

-

-

-

1

53

38

1

-

1

-

-

-

28

279

-

2

1
3
1

1
-

-

-

13
2
832
12
9

18
53
43
456
46

-

1
1
1
6

* Not appropriate for Roche Urisys 1100 users.

17
Protein – Qualitative, Method 2

CM-16

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

75
mg/dL
10-20 30-70 (Roche
Negative mg/dL mg/dL only)*

100-200
mg/dL

300-600
mg/dL

≥500
mg/dL
(IRIS
only)*

>600 or
≥1000
mg/dL

-

-

-

-

3

383

36

15

-

-

-

-

-

2

57

-

-

-

-

-

7

9

153

-

-

-

-

-

1
3
-

135
18
152
33
18

3
-

1
2

-

-

-

-

-

91

1

1

-

-

-

-

2

245

-

63

1
-

1
-

-

-

2
24
2
1

30
55
849
469
36

-

1
4
1
25

* Not appropriate for Roche Urisys 1100 users.

18
Glucose, Method 1

CM-14

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

10
10

-

-

-

-

-

220

-

-

-

-

-

10

-

-

-

-

-

11
10

-

-

-

-

-

10
10

-

-

-

-

-

28

-

-

-

-

-

25

-

3

-

-

-

92

-

-

-

-

-

100
89
23
32

-

-

1
-

1

-

30

-

-

-

-

-

220

-

-

-

-

-

22
23
453
17
390
94

-

-

-

1
-

-

19
Glucose, Method 1

CM-15

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

10
10

-

-

-

-

-

220

-

-

-

-

-

10

-

-

-

-

-

11
10

-

-

-

-

-

10
10

-

-

-

-

-

28

-

-

-

-

-

27

-

1

-

-

-

92

-

-

-

-

-

99
89
23
33

-

-

-

-

-

30

-

-

-

-

-

219

-

-

-

-

-

22
23
453
17
389
93

-

-

-

-

-

20
Glucose, Method 1

CM-16

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

4+

Negative

Trace

1+

2+

3+

-

-

10
10

-

-

-

-

1

1

23

194

1

-

-

-

6

4

-

-

-

11
10

-

-

-

-

-

10
10

-

-

-

-

-

-

26

2

-

-

-

1

6

18

3

-

1

-

2

87

2

1
1
-

-

1
1
1
1

80
20
5
1

15
61
14
11

2
6
3
20

-

-

-

5

22

3

-

-

191

28

1

-

1
4
2
-

5
2
2

10
7
122
14
244
34

9
11
294
3
128
33

2
4
26
12
17

1
3
1
7

21
Glucose, Method 2

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

30-100
mg/dL

150-300
mg/dL

500*
mg/dL

>500 or
≥1000
or
≥2000
mg/dL

463

-

-

-

-

54

3

-

-

-

171

-

-

-

-

144
17
165
33
70

-

-

1
-

-

95

-

-

-

-

323

-

-

-

-

33
54
897
482
139

-

1
-

1
-

-

*Roche Glucose Visual Users: Results may be reported as 500 mg/dL.
All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL.

22
Glucose, Method 2

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

30-100
mg/dL

150-300
mg/dL

500*
mg/dL

>500 or
≥1000
or
≥2000
mg/dL

462

1

-

-

-

56

1

-

-

-

171

-

-

-

-

145
17
166
33
70

-

-

-

-

94

-

-

-

-

323

-

-

-

-

33
54
897
481
138

1
-

1

1
1
-

-

*Roche Glucose Visual Users: Results may be reported as 500 mg/dL.
All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL.

23
Glucose, Method 2

CM-16

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

>500 or
≥1000
or
≥2000
mg/dL

Negative

30-100
mg/dL

150-300
mg/dL

500*
mg/dL

-

-

438

20

5

-

-

20

35

2

-

-

4

31

136

-

1
-

126
14
145
26
10

1
2
20

16
3
19
7
40

-

-

22

1

72

-

1

290

28

3

1
7
3
-

1
7
5
1

15
10
231
273
41

14
29
583
178
54

3
14
71
24
44

*Roche Glucose Visual Users: Results may be reported as 500 mg/dL.
All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL.

24
Reducing Substance

CM-14

Method/Instrument
Bayer Clinitest, 2 Drop*
Visual
Bayer Clinitest, 5 Drop
Siemens Clinitek 500, Advantus
Visual

CM-15

Method/Instrument
Bayer Clinitest, 2 Drop*
Visual
Bayer Clinitest, 5 Drop
Siemens Clinitek 500, Advantus
Visual

CM-16

Method/Instrument
Bayer Clinitest, 2 Drop*
Visual
Bayer Clinitest, 5 Drop
Siemens Clinitek 500, Advantus
Visual

¼%
Negative (Trace)

½%

¾%*

1%

≥2%

203

1

-

-

-

-

11
2189

1

-

1

2

1

½%

¾%*

1%

≥2%

¼%
Negative (Trace)

199

5

-

-

-

-

11
2185

8

-

-

1

-

½%

¾%*

1%

≥2%

¼%
Negative (Trace)

2

4

11

5

49

133

12

12

39

2
239

5
1234

4
660

* Please note ¾% is not an appropriate response for the Bayer Clinitest, 2-drop method.

25
Ketones, Method 1

CM-14

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Visual
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace

Small

-

-

-

-

10
10

-

-

-

1

44

-

-

-

-

10
10

-

-

-

-

10

-

-

-

-

10

-

-

5

22

1

1
-

-

-

1
1
3

9
16
12

-

-

-

6

13

1
3

-

4
1
-

29
2
7

26
38
96

26

Moderate

Large
Ketones, Method 1

CM-15

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Visual
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace

Small

Moderate

Large

10
10

-

-

-

-

45

-

-

-

-

10
10

-

-

-

-

10

-

-

-

-

10

-

-

-

-

28

-

-

-

-

10
18
15

-

-

-

-

19

-

-

-

-

60
40
102

-

-

1

2

27
Ketones, Method 1

CM-16*

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Visual
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace

Small

Moderate

Large

10
10

-

-

-

-

-

3

40

2

-

10
10

-

-

-

-

10

-

-

-

-

10

-

-

-

-

-

17

11

-

-

-

1
1
1

7
9
8

2
8
5

1

-

12

7

-

-

5
4
64

40
22
24

14
11
7

1
2
7

1
1
4

* Specimen CM-16 was not graded due to lack of participant consensus.

28
Ketones, Method 2

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

2

-

-

14

227

2

-

-

-

7

3

-

-

-

-

2

26

-

-

-

-

17

12

-

1

-

10

69

6

-

1

-

1
2

3
9
13

100
37
16
67

1
60
-

-

-

-

2

31

4

-

-

-

65

160

1

2
-

1
-

15
1
-

5
1
265
3
22
4

16
16
152
13
228
43

1
2
111
5

29
Ketones, Method 2

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

245

-

-

-

-

-

10

-

-

-

-

-

28

-

-

-

-

-

29

-

-

-

-

-

86

-

-

-

-

-

104
97
26
82

-

1

-

-

-

37

-

-

-

-

-

225

-

-

-

-

-

21
18
438
16
362
51

-

-

1

-

-

30
Ketones, Method 2

CM-16*

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
BioSys/Consult Diag/PSS
Select/YD Diag Urine Analyzer
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

-

3

228

12

2

-

-

3

7

-

-

-

27

1

-

-

-

-

-

-

28

1

-

-

-

48

35

4

-

-

1
14

4
2

58
26
24
45

42
47
1
21

23
1

1
-

-

-

4

30

3

-

7

127

94

-

-

-

34
22
27

15
9
279
12
140
14

6
9
124
4
186
4

2
15
4

3

-

* Specimen CM-16 was not graded due to lack of participant consensus.

31
Ketones, Method 3

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

5-10
mg/dL

1

-

-

15-20
mg/dL

40 - 60
mg/dL

80 - 100
mg/dL

1

14

372

3

-

-

-

39

14

1

-

18

1

126

1

-

-

1
-

4
5
2
9

1
2
-

125
12
136
19

-

-

1

-

-

86

-

-

1

89

205

3

1
-

1
-

1
11
-

6
6
486
26
6

18
47
339
319
45

4
1
7
119
16

Negative

5-10
mg/dL

15-20
mg/dL

40 - 60
mg/dL

80 - 100
mg/dL

≥150
mg/dL

390

-

-

-

1

-

53

-

-

-

-

-

147

-

-

-

-

-

131
17
140
28

-

-

-

-

-

87

-

-

-

-

-

299

-

-

-

-

-

31
54
842
463
67

-

-

-

-

1
1
-

32

≥150
mg/dL
Ketones, Method 3

CM-16*

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

5-10
mg/dL

15-20
mg/dL

-

221

157

-

-

-

80 - 100
mg/dL

≥150
mg/dL

12

1

-

44

2

3

-

75

68

-

2

-

1
1
-

6
5
3
-

74
9
76
24

49
3
59
4

1
-

1
-

-

1

9

75

2

-

9

172

111

2

-

-

2
3
70
30
35

23
27
472
204
20

6
23
289
205
8

4
14
4

1
-

-

Negative

* Specimen CM-16 was not graded due to lack of participant consensus.

33

40 - 60
mg/dL
Bilirubin, Method 1

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Ictotest
Visual
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Ictotest
Visual
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace/Small

Positive/Moderate

Large

370

-

-

-

28
29

-

-

-

20

-

-

-

320

-

-

-

11

-

-

-

32
54
862
492
115

1
-

3
-

2
-

Negative

Trace/Small

Positive/Moderate

Large

370

-

-

-

27
29

-

-

-

20

-

-

-

320

-

-

-

11

-

-

-

32
53
865
492
115

-

1
-

1
-

34
Bilirubin, Method 1

CM-16

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Ictotest
Visual
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace/Small

2

-

51

317

-

-

10
13

17
16

-

1

4

15

2

1

162

153

1

-

6

4

3
1

2
-

4
3
640
8
8

28
51
225
481
106

35

Positive/Moderate

Large
Bilirubin, Method 2

CM-14

Method/Instrument
ACON Mission Reagent Sticks
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

10
10

-

-

-

-

-

208

-

-

-

2

-

10

-

-

-

-

-

11
11

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

27

-

-

-

-

-

100
10
83
22
90

-

1

-

-

-

32

-

-

-

-

-

207

-

-

-

-

-

20
15
375
16
300
66

-

1
-

1
-

-

1
-

36
Bilirubin, Method 2

CM-15

Method/Instrument
ACON Mission Reagent Sticks
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

10
10

-

-

-

-

-

210

-

-

-

-

-

10

-

-

-

-

-

11
11

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

27

-

-

-

-

-

99
10
83
22
91

-

-

1
-

-

-

32

-

-

-

-

-

206

-

-

-

-

-

20
15
377
16
301
66

-

-

-

-

-

37
Bilirubin, Method 2

CM-16

Method/Instrument
ACON Mission Reagent Sticks
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

-

-

-

-

10
10

-

-

1

3

-

57

149

-

-

-

-

10

-

-

-

-

1

11
10

-

-

-

-

-

10

-

-

-

-

-

10

-

4

-

-

-

23

-

-

1

-

3
2
-

99
7
80
22
90

1
1
-

-

-

-

-

32

-

-

-

1

111

94

1

1
-

-

1
-

3
264
7
1
5

16
15
112
9
298
57

1
4

38
Bilirubin, Method 3

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400

CM-16

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400

Negative

0.5 -1.0
mg/dL

2.0 – 4.0
mg/dL

6.0 – 10.0
mg/dL

>10.0
mg/dL

81

-

-

-

-

111
16
132
27

-

-

-

-

67

-

-

-

-

Negative

0.5 -1.0
mg/dL

2.0 – 4.0
mg/dL

6.0 – 10.0
mg/dL

>10.0
mg/dL

81

-

-

-

-

111
16
131
27

-

-

1
-

-

67

-

-

-

-

Negative

0.5 -1.0
mg/dL

2.0 – 4.0
mg/dL

6.0 – 10.0
mg/dL

>10.0
mg/dL

-

-

1

13

67

-

-

-

111
16
129
27

3
-

-

1

-

66

-

39
Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 1

CMP1-04

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-05

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-06

Method/Instrument

Negative

Trace/Small

Positive/Moderate

Large

28

-

-

-

146

-

-

-

Negative

Trace/Small

Positive/Moderate

Large

28

-

-

-

147

-

-

-

Negative

IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

Trace/Small

Positive/Moderate

Large

1

-

10

16

2

25

113

6

Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 2

CMP1-04

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-05

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-06

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

Negative

Trace

1+

2+

3+

4+

17

-

-

-

-

-

61

-

-

1

-

-

1+

2+

3+

4+

Negative

Trace

17

-

-

-

-

-

62

-

-

1

-

-

1+

2+

3+

Negative

Trace

4+

-

-

-

3

13

1

3

-

7

53

-

-

40
Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 3

CMP1-04

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-05

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-06

Method/Instrument
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

Negative

0.5 -1.0
mg/dL

2.0 – 4.0
mg/dL

6.0 – 10.0
mg/dL

>10.0
mg/dL

22

-

-

-

-

25

-

-

-

-

Negative

0.5 -1.0
mg/dL

2.0 – 4.0
mg/dL

6.0 – 10.0
mg/dL

>10.0
mg/dL

22

-

-

-

-

25

-

-

-

-

Negative

0.5 -1.0
mg/dL

2.0 – 4.0
mg/dL

6.0 – 10.0
mg/dL

>10.0
mg/dL

-

-

22

-

-

2

-

23

-

-

41
Blood or Hemoglobin, Method 1

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Marked
Positive/Moderate Positive/Large

Negative

Trace/Small

1

2

197

159

-

-

-

40

1

2

124

29

-

-

-

24
24

-

-

-

18

1

-

8

302

1
-

2

6
38
57
3

32
51
842
418
143

Negative

Trace/Small

-

1

304

54

-

-

6

34

1

2

121

32

-

1

-

24
23

-

-

-

18

1

-

9

301

1
1
-

1
1
-

3
8
38
86
9

29
48
840
386
139

42

Marked
Positive/Moderate Positive/Large
Blood or Hemoglobin, Method 1

CM-16

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Marked
Positive/Moderate Positive/Large

Negative

Trace/Small

-

2

95

262

-

-

2

38

-

2

92

62

-

-

1
-

23
24

-

-

-

18

1

-

3

307

-

1
1
2

2
20
17
2

32
56
859
457
144

43
Blood or Hemoglobin, Method 2

CM-14

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

5+

-

-

-

-

10
10

-

-

-

-

-

146

108

1

-

-

-

-

-

11
11

-

-

-

-

-

-

10

-

-

-

-

-

-

10

-

-

-

-

-

5

23

-

-

-

-

1

5

27

-

-

-

-

2

68

18

-

-

1
1
-

-

-

7
6

10
7
10

101
32
14
18

47
-

-

-

-

-

13

19

4

1

-

1

5

224

2

-

1
-

-

1

2
13
54
1

20
15
419
16
299
75

1
1
2

1
2
2

44
Blood or Hemoglobin, Method 2

CM-15

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

5+

-

-

-

-

10
10

-

-

-

-

-

215

40

-

-

-

-

-

-

11
11

-

-

-

-

-

-

10

-

-

-

-

-

-

10

-

-

-

-

-

22

6

-

-

-

-

1

6

26

-

-

-

-

2

66

20

-

-

-

1

-

8
4

11
8
11

100
31
14
18

47
-

-

-

-

-

11

21

4

1

-

1

6

222

2

-

1

1
-

-

1
4
9
1
92
3

19
12
423
15
262
73

1
2
2

1
1
2

45
Blood or Hemoglobin, Method 2

CM-16

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

5+

-

-

-

-

10
10

-

-

-

-

-

69

186

-

-

-

-

-

-

11
11

-

-

-

-

-

-

10

-

-

-

-

-

-

10

-

-

-

-

-

-

28

-

-

-

-

1

2

30

-

-

-

-

2

52

34

-

-

1

1
-

-

7
5

10
6
1
10

100
34
14
18

47
-

-

-

-

-

11

21

4

-

-

-

2

229

2

-

1
1
-

-

-

3
16
1

20
17
429
15
337
74

1
1
4

1
2
2

46
Blood or Hemoglobin, Method 3
5 – 25

CM-14
CM-15

Method/Instrument
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

CM-16

Method/Instrument
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

Negative

Ery/µL

Ery/µL

Ery/µL

1
1
-

-

1
2
1
-

106
16
139
33
64

-

-

-

71

-

1

2
8

30
29

50 – 150

250

Negative

Ery/µL

Ery/µL

Ery/µL

-

-

1
2
1

108
17
138
34
63

1

-

-

70

-

1

2
9

30
28

5 – 25

Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

250

5 – 25

Method/Instrument

50 – 150

50 – 150

250

Negative

Ery/µL

Ery/µL

Ery/µL

-

-

1
2
1
-

107
16
139
34
64

-

-

-

71

1

1

2
2

30
34

47
Blood or Hemoglobin, Method 4

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

CM-16

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY

±0.03
mg/dL

Negative

0.06 – 0.10
mg/dL

0.20 – 0.50
mg/dL

≥1.0
mg/dL

-

-

-

31

30

-

-

-

2

10

-

-

-

10

8

0.06 – 0.10
mg/dL

0.20 – 0.50
mg/dL

≥1.0
mg/dL

±0.03
mg/dL

Negative

-

-

-

48

13

-

-

-

1

11

-

-

-

10

8

0.06 – 0.10
mg/dL

0.20 – 0.50
mg/dL

≥1.0
mg/dL

±0.03
mg/dL

Negative

-

-

-

10

51

-

-

-

-

12

-

-

-

9

9

48
Leukocyte Esterase, Method 1

CM-14

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace

Large

Positive*

-

-

-

-

10
10

-

-

-

1

1

354

1

-

-

-

-

10
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

37

-

1

-

-

-

140

11

1

-

-

5
6

16
11

2
-

-

-

-

4

14

-

-

1

-

12

285

1

1
-

1
-

4
8
4
107
2

14
31
695
188
51

12
19
180
176
79

2
4
1

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

49

Small

Moderate
Leukocyte Esterase, Method 1

CM-15

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace

Small

Moderate

Large

Positive*

10
10

-

-

-

-

-

357

-

-

1

-

-

10
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

33

2

2

-

-

-

151

1

-

-

-

-

23
17

-

1

-

-

-

18

-

-

-

-

-

299

-

-

-

-

-

30
56
879
475
129

1
1
1

1

-

2
1

-

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

50
Leukocyte Esterase, Method 1

CM-16

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
CTMI / Thermo Fisher Reagent
Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Diagnostic Test Group Clarity
Urocheck 120
Visual
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Status
Visual

Negative

Trace

Small

-

-

-

-

10
10

-

-

-

3

3

350

1

-

-

-

-

10
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

1

36

-

-

-

-

4

137

11

-

-

-

4
6

17
11

2
1

-

-

-

5

13

-

-

1

-

96

201

1

1
1
1

1
4
15
38
7

11
46
456
403
76

18
3
401
4
38

5
6
31
9

2
1
1

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

51

Moderate

Large

Positive*
Leukocyte Esterase, Method 2

CM-14

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

1+

2+

3+

4+

Positive*

-

-

6

185

8

-

-

-

-

4

6

-

-

-

-

-

-

20

-

-

-

-

-

-

16

-

1

-

-

-

2

83

1

-

-

-

1
3

106
29
8
70

3
59
13
17

1
-

1
-

-

-

-

20

16

-

-

1

-

-

7

216

2

1

1
1
-

2
-

1
1
3
76
-

17
11
345
168
47

5
5
79
16
118
31

1
1
2
-

-

Negative

Trace

1

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

52
Leukocyte Esterase, Method 2

CM-15

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100 **
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

Positive*

199

-

-

-

1

-

-

10

-

-

-

-

-

-

20

-

-

-

-

-

-

12

2

3

-

-

-

-

86

-

-

-

-

-

-

111
89
21
90

-

-

-

-

-

-

36

-

-

-

-

-

-

224

-

1

-

1

-

-

23
18
430
16
365
77

1
-

-

-

1

-

-

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.
** Specimen CM-15 for this peer group was not graded due to lack of participant consensus.

53
Leukocyte Esterase, Method 2

CM-16

Method/Instrument
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Negative

Trace

1+

2+

3+

4+

Positive*

-

-

-

7

185

8

-

-

-

-

7

3

-

-

-

-

-

3

17

-

-

-

-

-

-

16

-

1

-

-

-

3

82

1

-

-

-

2
1
20

105
29
7
61

2
59
13
9

1
-

1
1
-

-

-

-

20

16

-

-

-

-

-

91

134

1

1

1
1

11
15
5

10
16
228
328
47

11
1
189
7
8
22

2
1
3
8
13
3

1
-

-

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

54
Leukocyte Esterase, Method 3
25

75 or 100

Negative

µL

µL

1

-

-

250 or 500

Positive*

-

113

4

-

-

30

1

-

-

-

27

-

1
-

-

1
-

106
17
144
32

1

-

-

-

71

-

-

-

-

12

-

-

-

17
19

14
6

-

75 or 100

Negative

µL

µL

250 or 500

116

-

28

ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips
(800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

Method/Instrument

CM-15

µL

25

CM-14

Method/Instrument

ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips
(800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

µL

Positive*

-

2

-

3

-

-

-

27

-

-

-

-

107
17
144
33

-

-

1
-

-

71

-

-

-

-

12

-

-

-

-

31
25

-

-

-

-

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

55
Leukocyte Esterase, Method 3
25

CM-16

Method/Instrument

75 or 100

Negative

µL

µL

-

-

-

ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips
(800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 500, Advantus
Siemens Clinitek Status

250 or 500

µL

Positive*

-

115

3

-

-

30

1

-

-

-

27

-

-

-

1
-

107
17
144
32

1

-

-

2

69

-

-

-

3

9

-

-

3

28
20

4
1

-

* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

56
Nitrite

CM-14

Method/Instrument

Negative

ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD Diag
Reagent Strips
BioSys/Consult Diag/PSS Select/YD Diag
Urine Analyzer
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity Urocheck
Reagent Strips
Diagnostic Test Group Clarity Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips (8007212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Positive

1

678

-

11

-

11
11

-

10
10

-

23

-

85

1

259

1
-

241
26
245
56
99

-

125

-

536

1
2
-

57

11
10

54
77
1339
18
861
210
Nitrite

CM-15

Method/Instrument

Negative

ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD Diag
Reagent Strips
BioSys/Consult Diag/PSS Select/YD Diag
Urine Analyzer
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity Urocheck
Reagent Strips
Diagnostic Test Group Clarity Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips (8007212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Positive

2

677

-

11

-

11
11

-

10
10

1

22

-

85

1

259

1
2
-

240
26
244
56
99

-

125

2

533

5
4
2

58

11
10

54
76
1333
18
859
208
Nitrite

CM-16*

Method/Instrument

Negative

ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD Diag
Reagent Strips
BioSys/Consult Diag/PSS Select/YD Diag
Urine Analyzer
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity Urocheck
Reagent Strips
Diagnostic Test Group Clarity Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips (8007212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

Positive

-

11
10

3

675

10

1

-

11
11

-

10
10

22

1

17

68

23

237

225
23
193
54
83

15
3
53
2
16

108

15

-

536

1
2
8
2
11
95

53
75
1330
16
852
114

* Specimen CM-16 was not graded due to lack of participant consensus.

59
Urobilinogen

CM-14

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips
(800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

1.0
Negative
4.0
≥8.0
or
mg/dL
or
or
0.0 - 0.2
or
2.0/3.0
4.0/6.0
12.0
<2.0
mg/dL
mg/dL
mg/dL
mg/dL
mg/dL
or
or
or
or
or
<3.2
µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive **

11
10

-

-

-

-

-

365

278

-

1

-

-

11

-

-

-

-

-

11
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

23

5

-

-

-

-

66

14

-

-

-

-

170

81

-

-

-

-

221
25
245
54
89

2
2
1

-

-

-

-

118

-

-

-

-

-

486

3

-

-

-

-

48
63
1167
17
719
165

5
1
1

1
3
-

-

2
1

1
2
-

** Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

60
Urobilinogen

CM-15

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips
(800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

1.0
Negative
4.0
≥8.0
or
mg/dL
or
or
0.0 - 0.2
or
2.0/3.0
4.0/6.0
12.0
<2.0
mg/dL
mg/dL
mg/dL
mg/dL
mg/dL
or
or
or
or
or
<3.2
µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive **

11
10

-

-

-

-

-

364

280

-

-

1

-

11

-

-

-

-

-

11
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

-

-

-

23

5

-

-

-

-

64

15

-

-

-

-

168

83

-

-

-

-

221
25
245
54
89

2
2
1

-

-

-

-

118

-

-

-

-

-

488

1

-

-

-

-

48
62
1170
17
720
167

5
1
-

1
3
-

-

-

1
-

** Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

61
Urobilinogen

CM-16

Method/Instrument
ACON Mission Reagent Strips
ACON Mission U120, U500
Visual
ARKRAY Aution Sticks
ARKRAY/IRIS Aution Max/iQ200
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
BioSys/Consult Diag/PSS Select/YD
Diag Urine Analyzer
CTMI / Thermo Fisher Reagent Strips
CTMI CT-120 Urine Analyzer
Visual
Diagnostic Test Group Clarity
Diagnostic Test Group Clarity
Urocheck 120
Visual
Eiken Uropaper
Eiken US-3100R/3100Rplus
IRIS iChem Reagent Strips
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips
(800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur
Roche Chemstrip Criterion/II
Roche Chemstrip Urine Analyzer
Roche cobas u411, Urisys 1800
Roche Urisys 1100
Visual
Roche Urisys Cassette
Roche Urisys 2400
Siemens Clinitek Atlas Reagent
Siemens Clinitek Atlas
Siemens Reagent Strips
Siemens Clinitek 10 or 100
Siemens Clinitek 50
Siemens Clinitek 500, Advantus
Siemens Clinitek Atlas
Siemens Clinitek Status
Visual

1.0
Negative
4.0
≥8.0
or
mg/dL
or
or
0.0 - 0.2
or
2.0/3.0
4.0/6.0
12.0
<2.0
mg/dL
mg/dL
mg/dL
mg/dL
mg/dL
or
or
or
or
or
<3.2
µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive **

-

-

-

11
10

-

-

-

1

17

616

9

2

-

-

-

-

11

-

-

-

-

11
10

-

-

-

-

-

10

-

-

-

-

-

10

-

-

1

-

6

21

-

-

-

1

1

4

69

5

-

-

3

239

2

7

3
1
1

1

1
1

1
5
2
10

218
25
237
49
77

1
4
2
-

-

-

-

-

118

-

-

-

2

428

59

-

1
5
-

1
1

-

1
5
12
3

47
62
1163
5
723
162

3
2
1

** Appropriate for IRIS iChemVELOCITY and iChem 100 users only.

62
Urine Sediment Photographs

CMP-17

Case History CMP-17 through CMP-20
This urine sample is from a 37-year-old man with advanced kidney disease, admitted through the emergency
room (ER) for lower abdominal discomfort and painful urination. Laboratory data include: specific gravity = 1.017,
pH = 5.0; blood, leukocyte esterase, protein, glucose, ketones, and nitrite = positive.

CMP Participants
No.
%

Identification
Granular cast

4393

96.8

Performance
Evaluation
Good

The arrowed object is a granular cast as correctly identified by 96.8% of the participants.
Urinary casts are cylindrical objects that form in the distal tubules and collecting ducts as a result of
solidification of protein within the renal tubular lumen. Casts are sub-classified based on their matrix
composition (hyaline, waxy), inclusions (granules, fat, hemosiderin), or cellular composition (white cells, red
cells, renal tubular epithelial cells, bacteria).
Granular casts as depicted in this image are a common finding in urine specimens. This cast is made up of
plasma proteins from degenerated cellular products and may have a fine or coarse granular appearance that
is often evenly dispersed throughout the cast. Most granular casts are not pathological; however, these casts
can be seen in urine from individuals with renal disease.

63
CMP-18

Urine Sediment Photographs

CMP Participants
No.
%

Identification
Erythrocyte, mature

4463

98.4

Performance
Evaluation
Good

The arrowed object is a red blood cell that is correctly identified by 98.4% of the participants. Red blood cells
in wet preparations appear as pale yellow-orange discs that are usually about 7 to 8 μm in diameter. The
appearance of red blood cells depends upon the age and condition of the urine specimen. Old hypotonic urine
specimens make red blood cells appear as “ghost-like,” faint, colorless circles. Red blood cells in hypertonic
urine samples can appear more crenated. Oil droplets can mimic red blood cells but the refractile nature of oil
droplets is a helpful distinction. Crenated red cells may be confused with white blood cells, which unlike red
blood cells have multilobated nuclei. Generally, only a small number of red blood cells are seen in urine (less
than 3/HPF); however, increased numbers of red blood cells can be associated with kidney disease,
inflammation, trauma, or bleeding disorders.

64
CMP-19

Urine Sediment Photographs

CMP Participants
Identification

Performance

No.

Evaluation

4377

Waxy Cast

%
96.5

Good

The arrowed image is a waxy cast which was correctly identified by 96.5% of the participants. Waxy casts are
usually broad and stubby with a homogenous smooth and dense appearance. The ends are often blunted
with well-defined parallel margins that may be serrated or notched which reflect its brittle nature. Waxy casts
are thought to arise from the degeneration of cellular casts and are frequently associated with severe or
progressive chronic renal disease. These waxy casts can be differentiated from hyaline casts due to their
highly refractile nature.

65
CMP-20

Urine Sediment Photographs

CMP Participants
No.
%

Identification
Calcium oxalate crystals

4533

99.9

Performance
Evaluation
Good

The arrowed objects are calcium oxalate crystals which were correctly identified by 99.9% of the participants.
Calcium oxalate crystals can have various forms. The classic form is the dihydrate form, as depicted in this
image, which appears as a colorless octahedron with the morphologic features of an envelope. The
monohydrate form has an oval, elliptical, or dumbbell shape. Large numbers of oxalate crystals can be seen
in chronic renal disease, ethylene glycol (antifreeze) toxicity, or in patients who consume foods rich in oxalic
acid (ie, tomatoes, apples, asparagus, oranges, or carbonated beverages). Calcium oxalate crystals can
cause renal calculi.

George Girgis, MT
Hematology and Clinical Microscopy Resource Committee

66
Body Fluid Photographs
Case History CMP-21 through CMP-26
The patient is a 38-year-old, immunocompromised man who presents with fever, shortness of breath, and
nonproductive cough. Bronchioalveolar lavage (BAL) is performed and shows: total nucleated cells = 6100/μL (6.1
× 10 /μL) and RBC = 400/μL (0.4 × 10 /μL).

Referees
No.
%

CMP-21

Identification

CMP Participants
No.
%

Performance
Evaluation

Monocyte/macrophage

3

33.3

1083

43.5

Non-consensus

Mesothelial cells

3

33.3

746

29.9

Non-consensus

Macrophage containing hemosiderin (Siderophage)

1

11.1

180

7.2

Non-consensus

Bronchial lining cell

1

11.1

156

6.3

Non-consensus

The arrowed cell represents a monocyte/macrophage, as was correctly identified by 43.5% of the participants.
Monocytes and macrophages represent a continuum on the mononuclear phagocytic series, with monocytes
typically referring to cells circulating in the blood, while macrophages represent more mature forms that have
undergone further differentiation after migration into tissues. Alveolar macrophages typically are the
predominant cells in bronchoalveolar lavage fluid and have similar morphology to the macrophages seen in
other body fluids. They have an eccentric round nucleus and abundant blue-grey cytoplasm, with small
numbers of azurophilic granules, vacuoles, and may contain ingested material such as hemosiderin, RBCs or
nucleated cells, microorganisms, or lipid. Cytoplasmic black carbon particles can also be observed in alveolar
macrophages of smokers. Mature macrophages can sometimes be difficult to differentiate from mesothelial
cells in some types of specimens. An important clue here that the cell is a macrophage and not a mesothelial
cell is the specimen source, namely bronchoalveolar lavage. Mesothelial cells are lining cells of the peritoneal,
pericardial, and pleural cavities, whereas the lining cells of the bronchial tree have a distinctly different
appearance and are columnar and ciliated. When peritoneal, pericardial, and pleural fluids are being
examined, distinguishing features of mesothelial cells that may be helpful in differentiating from macrophages
include the biphasic cytoplasmic staining, with a lightly staining perinuclear area and a deeper blue periphery;
the more pronounced surface membrane projections; and the presence of “windows” between mesothelial
cells in clusters, which are clear spaces between individual cells.
67
CMP-22

Body Fluid Photographs

CMP Participants
No.
%
1653

Macrophage containing abundant small
lipid vacuoles/droplets (Lipophage)
Monocyte/macrophage

66.5

Educational

429

Identification

Performance
Evaluation

17.3

Educational

Neutrophil/macrophage with phagocytized
133
5.3
Educational
fungi
Macrophage containing hemosiderin
70
2.8
Educational
(Siderophage)
The arrowed cell represents a lipophage, as was correctly identified by 66.5% of the participants.
Identification as a monocyte/macrophage is also acceptable. A lipophage represents a macrophage
containing numerous cytoplasmic small fat droplets, which result from ingestion of extracellular lipids, such
as membranes from necrotic cells. Large numbers of lipophages can be observed in pleural fluid in the
presence of chylothorax, or in cerebrospinal fluid following intrathecal chemotherapy or radiation therapy.

68
CMP-23

Body Fluid Photographs

Identification

CMP Participants
No.
%

Erythrocyte, mature

2481

99.3

Performance
Evaluation
Good

The arrowed cell represents a mature erythrocyte, as was correctly identified by 99.3% of the participants.
The presence of red blood cells (RBCs) in body fluids frequently indicates hemorrhage or traumatic
contamination of the body fluid with peripheral blood. Their morphology in body fluids is similar to that
observed in the peripheral blood: non-nucleated, round, with a zone of central pallor, although they can also
appear crenated because of preservation artifact.

69
CMP-24

Body Fluid Photographs

Identification

CMP Participants
No.
%

Performance
Evaluation

Pneumocystis jirovecii

1821

73.4

Educational

167

6.7

Educational

Bacteria - extracellular

94

3.8

Educational

Macrophage containing hemosiderin (Siderophage)

73

2.9

Educational

Degenerating cell, NOS

67

2.7

Educational

Yeast/fungi, extracellular

47

1.9

Educational

Stain precipitate

The arrowed object represents Pneumocystis jirovecii, as correctly identified by 73.4% of the participants.
Pneumocystis jirovecii (formerly Pneumocystis carinii) is an opportunistic fungal pathogen classified within
phylum Ascomycota, which causes severe pneumonia in immunocompromised patients. The life cycle of the
organism goes through a trophic and cystic form. Pneumocystis organisms are usually found within foamy
amorphous material present within lung alveoli. Trophic forms can be visualized on Wright-Giemsa stained
preparations and are typically 1-5 µm, pleomorphic, and contain a single nucleus. The wall of pneumocystis
cyst forms does not stain on Wright-Giemsa, making this form more difficult to identify, although the presence
of cyst forms may give the amorphous material a “honeycomb”-like appearance. Distinguishing Pneumocystis
structures from artifact may be challenging and can be aided through the use of immunofluorescent
monoclonal antibodies for direct detection in clinical specimens.

70
CMP-25

Body Fluid Photographs

Identification

CMP Participants
No.
%

Lymphocyte

2464

98.6

Performance
Evaluation
Good

The arrowed cell represents a lymphocyte, as was correctly identified by 98.6% of the participants. Mature
lymphocytes have round to oval nuclei with condensed chromatin and without visible nucleoli. The cytoplasm
is typically scant, agranular, and basophilic. In body fluid specimens, particularly cerebrospinal fluid,
centrifugation artifact can make mature lymphocytes appear to be larger than their counterparts in peripheral
blood and to have visible nucleoli and more abundant cytoplasm. Care should be taken to distinguish such
cytospin artifact from evidence of a hematolymphoid neoplasm. To the right of the lymphocyte, Pneumocystis
jirovecii organisms are seen, including small trophic forms containing a single small nucleus, as well as
several round lighter staining areas, representing cyst forms.

71
CMP-26

Body Fluid Photographs

CMP Participants
No.
%

Identification
Neutrophil, segmented or band

2463

98.6

Performance
Evaluation
Good

The arrowed cell represents a neutrophil, as was correctly identified by 98.6% of the participants. Neutrophils
are the most mature forms of the myeloid series with condensed nuclear chromatin and pale pink cytoplasm
containing specific bluish granules. The nucleus is typically segmented with 3-5 distinct lobes connected by
thin filaments. In the setting of infections, neutrophils can contain vacuoles, toxic granulation, Döhle bodies,
or ingested microorganisms. In body fluid specimens, cellular degeneration may result in nuclear pyknosis
and fragmentation. In some cases, pyknotic neutrophils may resemble nucleated red blood cells but can be
correctly identified by the characteristics of the cytoplasm, which is more eosinophilic than that of nRBCs and
may contain residual specific granules. Also of note is the Pneumocystis jirovecii present in the center of this
image.

72
Case Discussion: Pneumocystis in BAL
This case illustrates an example of Pneumocystis jirovecii pneumonia in an immunocompromised patient, with
evidence of Pneumocystis organisms in a bronchoalveolar lavage (BAL) specimen. Pneumocystis pneumonia
(PCP) can occur in patients infected with human immunodeficiency virus (HIV) and CD4 T-lymphocyte counts
<200/µL, where it is considered an acquired immunodeficiency syndrome (AIDS)-defining illness. PCP also can
be seen in patients whose immune system is compromised by malignancies, chemotherapy, stem cell or solid
organ transplantation, glucocorticoid use, particularly for rheumatologic conditions, or primary immune
deficiencies. Because of the severity of Pneumocystis-associated disease, prompt treatment is required and
prophylactic therapy is usually initiated in patients with low CD4 counts.
Pneumocystis is classified in the fungal kingdom (phylum Ascomycota) based on gene sequence similarities with
fungi, particularly in ribosomal RNA genes. Pneumocystis jirovecii refers to the human-specific form of the
organism, which highlights the fact that unique Pneumocystis forms have been identified in various mammalian
species with stringent host specificities. Pneumocystis is an obligate extracellular organism with a complex life
cycle that involves sexual and asexual reproduction and two morphologic forms: trophic, which are usually
haploid; and cystic, which can have 2-8 nuclei depending on the stage of development. Studying the genetics and
life cycle of this pathogen has been challenged by inability to culture it ex vivo, ie, outside the host lung, although
more recently advanced molecular and genomic techniques have been applied to elucidate its biology. According
to the current understanding of PCP, acquisition of Pneumocystis occurs via the airborne route and person-toperson transmission. It is thought that immunocompetent individuals undergo asymptomatic infections and can
therefore serve as a temporary reservoir for the organism.
The clinical presentation of PCP differs between HIV-infected and non-HIV patients. In the context of HIV, PCP
typically develops gradually, with low-grade fevers, progressive dyspnea, fatigue, and cough that is usually
nonproductive and less commonly productive of clear sputum. In non-HIV patients, fulminant respiratory failure is
common, requiring ventilatory support. Radiographic findings are similar in the two patient populations and
characterized by bilateral diffuse interstitial infiltrates. High-resolution computed tomography (CT) findings of
patchy or nodular ground-glass opacities are suggestive of PCP although not diagnostic. Given the relatively
nonspecific clinical presentation and radiographic findings, the diagnosis of PCP depends largely on the
laboratory identification of Pneumocystis, although that is somewhat limited by the inability to culture the
organism.
Microscopic identification of P. jirovecii is typically performed on BAL specimens obtained with bronchoscopy.
While induced sputum can also be used and is less invasive, it is considered suboptimal due to decreased
sensitivity and specificity compared to BAL, especially for patients receiving PCP prophylaxis. Lung biopsy tissue
is also an appropriate diagnostic specimen, however, it is associated with high cost and invasiveness and is
infrequently used. Various histochemical stains can be employed to detect P. jirovecii, but many of these
conventional stains may be unable to simultaneously detect trophic and cystic forms. A recent study directly
comparing four different staining techniques found that Grocott-Gomori methenamine silver stain (GMS) and
Calcofluor white fungal stain (CW) have superior sensitivity compared to Diff-Quik staining (~ 75% vs. ~ 50%,
respectively). In contrast, immunofluorescent monoclonal antibody staining can detect both life forms, providing
the highest sensitivity of all microscopic techniques (> 90%), although it tends to be more costly, time consuming,
and may be associated with a small decrease in specificity (~ 95% vs. >99% for the 3 conventional staining
methods).
Other methods have been developed recently for PCP diagnosis in order to increase the sensitivity of P. jirovecii
detection and/or avoid the invasiveness of bronchoscopy. Various methods employing polymerase chain reaction
(PCR) have been described and shown to have improved sensitivity compared to microscopy (94-100%
73
depending on the genomic target). The disadvantage of such assays is that they may also detect P. jirovecii DNA
in patients who are colonized by P. jirovecii but do not have associated pneumonia, which may lead to
unnecessary treatment. Efforts have also been made to detect markers of P. jirovecii infection in serum, the most
promising of which is β-D-Glucan (BDG) and may offer a noninvasive alternative to BAL. Although assays
detecting serum β-D-Glucan have been shown to perform well in HIV-infected patients, the characteristics of such
assays need to be further evaluated in different patient populations, particularly in the context of therapy.
Martina Lefterova, MD, PhD
Joan E. Etzell, MD, FCAP
Hematology and Clinical Microscopy Resource Committee
References:
1. Krajicek BJ, Limper AH, Thomas CF Jr. Advances in the biology, pathogenesis and identification of
Pneumocystis pneumonia. Curr Opin Pulm Med. 2008;14:228-234.
2. Procop GW, Haddad S, Quinn J, et al. Detection of Pneumocystis jiroveci in respiratory specimens by four
staining methods. J Clin Microbiol. 2004;42:3333-3335.
3. Thomas CF Jr., Limper AH. Current insights into the biology and pathogenesis of Pneumocystis pneumonia.
Nat Rev Microbiol. 2007;5:298-308.
4. Tietjen PA. Clinical presentation and diagnosis of Pneumocystis infection in HIV-infected patients. In: Basow
DS, ed. UpToDate. Waltham, MA: Wolters Kluwer Health; 2011. http://www.uptodate.com/contents/clinicalpresentation-and-diagnosis-of-pneumocystis-infection-in-hiv-infected-patients. Accessed January 9, 2013.

74
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013

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CAP's Survey in Clinical Microscopy 2013

  • 1. CM-B AND ANATOMIC PATHOLOGY EDUCATION PROGRAMS SURVEYS 2013 Clinical Microscopy PARTICIPANT SUMMARY 0.25 Hours of Self-Reported Training Available This document is available on e-LAB Solutions™. © 2013 College of American Pathologists. The College does not permit reproduction of any substantial portion of the material in this Report without its written authorization. The College hereby authorizes participants in the program to use the material in this Report solely for educational purposes within their own institutions. The College prohibits use of the material in the Report — and any unauthorized use of the College’s name or logo — in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services. Data from this program do not necessarily indicate the superiority or inferiority of instruments, reagents, or other materials used by participating laboratories. Use of these data to suggest such superiority or inferiority may be deceptive and misleading. The College will take all steps open to it under the law to prevent unauthorized reproduction of substantial portions of the material in this Report, deceptive use of any such material, and any unauthorized use of the College’s name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services.
  • 2. TABLE OF CONTENTS Program Update ........................................................................................................................................................ 1 Evaluation Criteria ..................................................................................................................................................... 2 CMP/CMP1 – Clinical Microscopy Bilirubin .................................................................................................................................................................. 34 Bilirubin, IRIS iChemVELOCITY and iChem 100 (CMP1 only)............................................................................. 40 Blood or Hemoglobin ............................................................................................................................................. 42 Glucose ................................................................................................................................................................. 19 Ketones ................................................................................................................................................................. 26 Leukocyte Esterase ............................................................................................................................................... 49 Nitrite ..................................................................................................................................................................... 57 Osmolality ................................................................................................................................................................ 3 pH, Urine ............................................................................................................................................................... 10 Protein (Qualitative) ............................................................................................................................................... 13 Reducing Substance ............................................................................................................................................. 25 Specific Gravity........................................................................................................................................................ 7 Urobilinogen .......................................................................................................................................................... 60 Urine hCG................................................................................................................................................................ 4 Urine Sediment Photographs ................................................................................................................................ 63 Body Fluid Photographs ........................................................................................................................................ 67 Case Discussion: Pneumocystis in BAL ............................................................................................................... 73 CMMP – Clinical Microscopy Miscellaneous Photographs ...................................................................................... 75 OCB – Occult Blood.................................................................................................................................................. 81 GOCB – Gastric Occult Blood Gastric Occult Blood .............................................................................................................................................. 82 Gastric pH.............................................................................................................................................................. 83 DSC – Dipstick Confirmatory Bilirubin, Confirmatory ........................................................................................................................................... 84 Protein, Confirmatory ............................................................................................................................................ 84 Actions Laboratories Should Take when a PT Result is Not Graded ....................................................................... 85 Attestation of Participation for Self-Reported Training ............................................................................................. 86 HEMATOLOGY AND CLINICAL MICROSCOPY RESOURCE COMMITTEE Joan E. Etzell, MD, FCAP, Chair Sherrie L. Perkins, MD, PhD, FCAP, Vice Chair Kyle T. Bradley, MD, MS, FCAP David R. Czuchlewski, MD, FCAP John L. Frater Jr., MD, FCAP Tracy I. George, MD, FCAP George M. Girgis, MT Eric D. Hsi, MD, FCAP David F. Keren, MD, FCAP Martina Lefterova, MD, PhD Jennifer L. Oliveira, MD, FCAP Jay L. Patel, MD, FCAP Janet Piscitelli, MD, FCAP Kathryn A. Rizzo, DO, PhD, FCAP Luke R. Shier, MD, FCAP Anna K. Wong, MD, FCAP David L. Zwick, MD, FCAP Maria A. Proytcheva, MD, FCAP, Liaison
  • 3. 2013 CM-B PARTICIPANT SUMMARY Program Update Don’t Miss Out on this Educational Opportunity! With your participation in CAP’s Surveys programs, every member of your team can take part in education activities: earn Continuing Education (CE) credits or receive Self-Reported Training* at no additional charge. This Survey mailing includes a Self-Reported Training activity. By reviewing the discussion that begins on page 63, your laboratory staff can earn 0.25 education hours that can be used towards fulfilling education and certification maintenance requirements. For your convenience, a form has been included to document your staff’s participation in the activity. See page 86. *CAP Self-Reported Training activities do not offer CE credit, but can be used towards fulfilling requirements for certification maintenance by agencies such as the American Society of Clinical Pathology (ASCP). Please verify with your certifying agency to determine your education requirements. 1
  • 4. Evaluation Criteria QUALITATIVE For qualitative procedures in urinalysis, evaluation is based on participant consensus by method and instrument. For each analyte, a minimum of two, but not more than four, responses will be given a passing score. Analyte results graded “Good” performance must have 80% participant consensus. Eighty percent participant consensus can be determined by grouping the mode with the next one or two most frequent responses. This group will be given “Good” performance. “Acceptable” performance will be given to additional responses until a minimum of 90% of participant results are given a passing score. In the case of a negative specimen, negative responses must constitute 90% participant consensus. Specimens with results for one of more methods distributed over both negative and positive responses (non-consensus) will not be evaluated. Specimens for which there is greater than 90% of participant responses distributed over more than four responses will be graded as “Non-consensus”. Analyte Bilirubin, Confirmatory Gastric Occult Blood Gastric pH Nitrate Occult Blood Protein, Confirmatory Urine hCG QUANTITATIVE Analyte Gastric pH Osmolality Specific Gravity Evaluation Criteria 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response Target Value Peer Group Mean Peer Group Mean Peer Group Mean Evaluation Criteria  3 SD  3 SD  2 SD or 0.010, whichever is greater Low and high values shown in the Participant Summary indicate the range of values reported. Low and high limits of acceptability are shown on the evaluation report. Data are not included for methods used by fewer than 10 laboratories. PHOTOGRAPHS Photographs are evaluated for CAP purposes according to 80% or greater consensus of either referees or participant laboratories. "Good" performance is given for the intended response. Additionally, the Hematology and Clinical Microscopy Resource Committee may, at its discretion, grant either "good" or "acceptable" performance for other equivalent responses. To provide a timely evaluation of your results, statistics presented in this Participant Summary reflect a minimum of 80% of participant enrollment. In the event a result is not graded, a numeric code will appear next to your result. A definition of the code will appear on the first page of the evaluation. Please see “Actions Laboratories Should Take when a PT Result is Not Graded” on page 85. 2
  • 5. No. Labs Mean S.D. C.V. CM-14 Advanced Instruments ARKRAY Fiske Precision Systems 997 50 84 25 866.4 862.8 868.1 857.5 4.8 3.7 6.3 7.9 0.6 0.4 0.7 0.9 CM-15 Advanced Instruments ARKRAY Fiske Precision Systems 1001 49 86 25 763.7 763.0 765.2 758.2 4.0 3.1 4.7 5.4 0.5 0.4 0.6 0.7 CM-16 Osmolality - mOsm/kg (mmol/kg) Advanced Instruments ARKRAY Fiske Precision Systems 1001 51 85 25 418.0 419.5 420.2 414.0 3.7 3.1 4.5 7.1 0.9 0.7 1.1 1.7 3
  • 6. Urine hCG The hCG level was intended to be positive. CM-14 Manufacturer Manufacturer's Stated Sensitivity Level mIU/mL Abbott TestPack Plus Combo w/ or w/out OBC Acceava Combo II ACON One Step (urine only) Alere hCG Cassette (20) (Acceava) Alere hCG Cassette (25) (Clearview) Alere hCG Combo Cassette (20/10) Alere hCG Combo Cassette (25) (Clearview) Beckman Coulter ICON 20 Beckman Coulter ICON 25 Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hCG Clearview hCG Combo II Eiken Meridian ImmunoCard STAT Polymedco Poly stat (serum/urine) Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Ramco Quik-Trak Combi Test (serum/urine) Randox Direct SA Scientific (SAS) Ultra SA Scientific (serum/urine) Sekisui OSOM Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID Plus Stanbio QuPID Plus E.R. Stanbio True 20 Plus Sure-Vue (urine only) Sure-Vue (serum/urine) Sure-Vue STAT (serum/urine) Technologist Choice (serum/urine) Other and Methods with <10 responses 25 20 25 20 25 25 20 - 4 Negative Positive 2 1 1 1 1 1 1 - 11 16 37 17 26 72 50 125 354 111 628 89 45 10 48 34 431 217 471 10 14 16 19 34 334 29 18 51 15 36 84 306 374 16 357
  • 7. Urine hCG The hCG level was intended to be positive. CM-15 Manufacturer Manufacturer's Stated Sensitivity Level mIU/mL Abbott TestPack Plus Combo w/ or w/out OBC Acceava Combo II ACON One Step (urine only) Alere hCG Cassette (20) (Acceava) Alere hCG Cassette (25) (Clearview) Alere hCG Combo Cassette (20/10) Alere hCG Combo Cassette (25) (Clearview) Beckman Coulter ICON 20 Beckman Coulter ICON 25 Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hCG Clearview hCG Combo II Eiken Meridian ImmunoCard STAT Polymedco Poly stat (serum/urine) Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Ramco Quik-Trak Combi Test (serum/urine) Randox Direct SA Scientific (SAS) Ultra SA Scientific (serum/urine) Sekisui OSOM Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID Plus Stanbio QuPID Plus E.R. Stanbio True 20 Plus Sure-Vue (urine only) Sure-Vue (serum/urine) Sure-Vue STAT (serum/urine) Technologist Choice (serum/urine) Other and Methods with <10 responses 25 20 25 20 25 25 20 - 5 Negative Positive 1 2 1 1 1 1 2 11 16 37 17 26 72 50 126 353 111 627 89 45 10 48 34 430 216 473 10 14 16 19 34 334 29 18 51 15 36 85 306 375 16 355
  • 8. Urine hCG The hCG level was intended to be positive. CM-16 Manufacturer Manufacturer's Stated Sensitivity Level mIU/mL Abbott TestPack Plus Combo w/ or w/out OBC Acceava Combo II ACON One Step (urine only) Alere hCG Cassette (20) (Acceava) Alere hCG Cassette (25) (Clearview) Alere hCG Combo Cassette (20/10) Alere hCG Combo Cassette (25) (Clearview) Beckman Coulter ICON 20 Beckman Coulter ICON 25 Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hCG Clearview hCG Combo II Eiken Meridian ImmunoCard STAT Polymedco Poly stat (serum/urine) Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Ramco Quik-Trak Combi Test (serum/urine) Randox Direct SA Scientific (SAS) Ultra SA Scientific (serum/urine) Sekisui OSOM Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID Plus Stanbio QuPID Plus E.R. Stanbio True 20 Plus Sure-Vue (urine only) Sure-Vue (serum/urine) Sure-Vue STAT (serum/urine) Technologist Choice (serum/urine) Other and Methods with <10 responses 25 20 25 20 25 25 20 - 6 Negative Positive 1 1 1 1 1 1 2 11 16 37 17 26 72 50 127 354 111 627 89 45 10 48 34 429 215 473 10 14 16 19 34 334 29 18 51 15 36 84 306 375 16 355
  • 9. Specific Gravity No. Labs CM-14 C.V. 1.0200 1.0200 0.0000 0.0000 0.0 0.0 1.0144 0.0012 0.1 11 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 10 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 12 1.0186 0.0017 0.2 74 1.0245 0.0015 0.1 199 1.0151 0.0007 0.1 28 11 1.0142 1.0144 0.0008 0.0022 0.1 0.2 171 11 38 210 1.0145 1.0190 1.0153 1.0174 0.0013 0.0010 0.0007 0.0011 0.1 0.1 0.1 0.1 232 25 239 51 85 1.0113 1.0128 1.0129 1.0115 1.0128 0.0022 0.0025 0.0027 0.0025 0.0031 0.2 0.3 0.3 0.2 0.3 117 1.0174 0.0009 0.1 518 1.0172 0.0015 0.1 12 27 903 18 162 180 Method/Instrument S.D. 461 ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diag. Test Group Clarity Urocheck Reag. Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY IRIS Mass Gravity Meter ARKRAY/IRIS Aution Max/iQ200 IRIS iChemVELOCITY Refractometer ARKRAY/IRIS Aution Max/iQ200 Eiken US-3100R/3100Rplus IRIS iChemVELOCITY Visual Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Mean 10 10 Method/Instrument 1.0263 1.0259 1.0251 1.0175 1.0282 1.0215 0.0031 0.0046 0.0016 0.0016 0.0025 0.0039 0.3 0.5 0.2 0.2 0.2 0.4 Low High 1.030 1.030 1.029 1.029 1.030 1.030 1.030 1.030 No. Labs Median Greater-Than Values Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status 37 43 347 639 7 1.030 1.030 1.030 1.030
  • 10. Specific Gravity No. Labs CM-15 C.V. 1.0205 1.0200 0.0015 0.0000 0.1 0.0 1.0122 0.0012 0.1 11 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 10 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 11 1.0154 0.0007 0.1 76 1.0191 0.0022 0.2 201 1.0133 0.0008 0.1 30 11 1.0119 1.0126 0.0012 0.0022 0.1 0.2 170 11 38 210 1.0121 1.0153 1.0133 1.0145 0.0011 0.0005 0.0007 0.0009 0.1 0.0 0.1 0.1 235 25 238 51 86 1.0133 1.0136 1.0131 1.0127 1.0080 0.0030 0.0023 0.0030 0.0032 0.0037 0.3 0.2 0.3 0.3 0.4 116 1.0145 0.0008 0.1 515 1.0150 0.0010 0.1 13 27 917 17 202 183 Method/Instrument S.D. 466 ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diag. Test Group Clarity Urocheck Reag. Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY IRIS Mass Gravity Meter ARKRAY/IRIS Aution Max/iQ200 IRIS iChemVELOCITY Refractometer ARKRAY/IRIS Aution Max/iQ200 Eiken US-3100R/3100Rplus IRIS iChemVELOCITY Visual Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Mean 11 10 Method/Instrument 1.0269 1.0252 1.0250 1.0148 1.0276 1.0190 0.0025 0.0050 0.0001 0.0006 0.0027 0.0043 0.2 0.5 0.0 0.1 0.3 0.4 Low High 1.030 1.030 1.030 1.029 1.030 1.030 1.030 1.030 No. Labs Median Greater-Than Values Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status 35 42 241 599 8 1.030 1.030 1.030 1.030
  • 11. Specific Gravity No. Labs CM-16 C.V. 1.0155 1.0150 0.0015 0.0000 0.1 0.0 1.0154 0.0014 0.1 11 10 1.0155 1.0150 0.0015 0.0000 0.1 0.0 10 10 1.0150 1.0150 0.0000 0.0000 0.0 0.0 12 1.0218 0.0013 0.1 76 1.0136 0.0025 0.2 201 1.0156 0.0008 0.1 32 11 1.0153 1.0152 0.0018 0.0021 0.2 0.2 169 11 37 208 1.0155 1.0218 1.0155 1.0200 0.0016 0.0009 0.0006 0.0009 0.2 0.1 0.1 0.1 233 25 238 52 86 1.0126 1.0144 1.0139 1.0129 1.0150 0.0026 0.0022 0.0026 0.0027 0.0020 0.3 0.2 0.3 0.3 0.2 116 1.0199 0.0008 0.1 503 1.0206 0.0010 0.1 50 68 1255 19 813 185 Method/Instrument S.D. 463 ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diag. Test Group Clarity Urocheck Reag. Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY IRIS Mass Gravity Meter ARKRAY/IRIS Aution Max/iQ200 IRIS iChemVELOCITY Refractometer ARKRAY/IRIS Aution Max/iQ200 Eiken US-3100R/3100Rplus IRIS iChemVELOCITY Visual Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Mean 11 10 Method/Instrument 1.0243 1.0207 1.0211 1.0205 1.0235 1.0187 0.0020 0.0025 0.0021 0.0008 0.0024 0.0044 0.2 0.2 0.2 0.1 0.2 0.4 Low High 1.025 1.030 No. Labs Median Greater-Than Values Siemens Reagent Strips Siemens Clinitek Status 10 9 1.030
  • 12. pH, Urine ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 - - - - - - - 10 10 - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7.5 8.0 8.5 ≥9.0 - - - - 674 6 - - - 8 3 - - - - - - 11 10 - - - - - - - 10 - - - - - - - - 10 - - - - - - - - - 24 5 - - - - - - - - - 84 - 1 - - - - - - - 4 - 260 - - - - - - - - - - 1 - 242 26 252 55 101 1 1 - - - - - - - - - - 126 - - - - - - - - - - - 543 1 - - - - - - - - 1 1 1 1 1 20 1 2 33 75 1327 18 865 119 21 1 3 89 1 2 - - CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur* Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual** Roche Urisys Cassette* Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual * Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5. ** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed. 10
  • 13. pH, Urine ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 - - - - - - - - 10 10 - - - - - - - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8.0 8.5 ≥9.0 - - - 581 98 - - 10 1 - - - - 1 - 10 10 - - - - - - 10 - - - - - - - 10 - - - - - - - - 5 24 - - - - - - - - - 85 - - - - - - 1 2 4 - 254 - 3 - - - - - - 1 - 1 6 3 1 1 2 187 25 247 49 94 - 54 5 3 - - - - - 1 - 6 1 118 - - - - - - - - - 1 538 4 - - - - - - - 2 1 3 1 5 2 5 174 1 23 13 12 62 588 16 493 86 40 8 584 281 106 1 1 1 70 - - CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur* Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual** Roche Urisys Cassette* Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual * Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5. ** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed. 11
  • 14. pH, Urine ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7.0 7.5 8.0 8.5 ≥9.0 10 10 - - - - 5 675 - - - - 1 9 1 - - - - - - 1 - 10 10 - - - - - - - - 10 - - - - - - - - - 10 - - - - - - - - - - 29 - - - - - - - - - - - 75 - 10 - - - - - - - 2 - 260 - - 2 - - - - - - 1 1 1 1 1 1 241 24 253 54 100 - 1 - - - - - - - - - - 126 - - - - - - - - - - 69 475 - - - - - - - 1 1 - 3 4 1 3 30 3 5 8 51 73 1315 15 863 190 2 8 2 2 - 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur* Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual** Roche Urisys Cassette* Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual * Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5. ** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed. 12
  • 15. Protein – Qualitative, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - - - 1 42 204 - - - - 3 5 2 - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 13 15 - - - 1 25 - - - - 5 87 1 1 - 1 1 - 1 3 1 10 105 38 9 73 53 13 1 - - - 1 27 4 - - - 1 208 18 1 - 2 1 2 125 1 16 20 18 333 15 371 110 4 10 1 21 49 13
  • 16. Protein – Qualitative, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - 1 - 1 243 1 1 - - - 8 2 - - - - 1 - 10 10 - - - - - 10 - - - - - 10 - - - - 1 27 - - - - 4 22 - - - - 86 7 - 1 - - 1 1 - 27 18 1 38 80 51 13 47 24 8 - - - - 16 14 2 - - - 12 209 5 1 - - 1 1 3 7 425 2 5 45 15 18 38 14 368 114 3 3 20 16 14
  • 17. Protein – Qualitative, Method 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - - - - 2 236 9 - - - - 3 7 - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 7 21 - - - - 26 - - - - 3 89 1 - - - 1 1 7 107 32 8 77 62 14 1 - 1 - - 25 6 - - - 1 179 46 1 1 1 - 1 2 1 12 2 19 21 18 442 13 371 93 4 13 2 19 63 15
  • 18. Protein – Qualitative, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 75 mg/dL 10-20 30-70 (Roche Negative mg/dL mg/dL only)* 100-200 mg/dL 300-600 mg/dL ≥500 mg/dL (IRIS only)* >600 or ≥1000 mg/dL 2 - - - 84 339 10 2 - - - - 1 2 56 - 1 - - - 18 9 141 - - - - - 4 2 23 1 2 132 16 132 32 17 3 - 1 1 - - - - 7 85 1 - - - - - 3 291 - 16 2 - 1 - - - 5 1 252 1 1 26 54 620 470 49 - 1 1 3 1 12 * Not appropriate for Roche Urisys 1100 users. . 16
  • 19. Protein – Qualitative, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 75 mg/dL 10-20 30-70 (Roche Negative mg/dL mg/dL only)* 100-200 mg/dL 300-600 mg/dL ≥500 mg/dL (IRIS only)* >600 or ≥1000 mg/dL 1 - 1 - 429 6 - - - - - - 8 2 49 - 2 - 1 - 144 1 21 - - - 1 - 43 11 83 6 6 93 7 73 27 12 2 - 1 1 - - - 1 53 38 1 - 1 - - - 28 279 - 2 1 3 1 1 - - - 13 2 832 12 9 18 53 43 456 46 - 1 1 1 6 * Not appropriate for Roche Urisys 1100 users. 17
  • 20. Protein – Qualitative, Method 2 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 75 mg/dL 10-20 30-70 (Roche Negative mg/dL mg/dL only)* 100-200 mg/dL 300-600 mg/dL ≥500 mg/dL (IRIS only)* >600 or ≥1000 mg/dL - - - - 3 383 36 15 - - - - - 2 57 - - - - - 7 9 153 - - - - - 1 3 - 135 18 152 33 18 3 - 1 2 - - - - - 91 1 1 - - - - 2 245 - 63 1 - 1 - - - 2 24 2 1 30 55 849 469 36 - 1 4 1 25 * Not appropriate for Roche Urisys 1100 users. 18
  • 21. Glucose, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 220 - - - - - 10 - - - - - 11 10 - - - - - 10 10 - - - - - 28 - - - - - 25 - 3 - - - 92 - - - - - 100 89 23 32 - - 1 - 1 - 30 - - - - - 220 - - - - - 22 23 453 17 390 94 - - - 1 - - 19
  • 22. Glucose, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 220 - - - - - 10 - - - - - 11 10 - - - - - 10 10 - - - - - 28 - - - - - 27 - 1 - - - 92 - - - - - 99 89 23 33 - - - - - 30 - - - - - 219 - - - - - 22 23 453 17 389 93 - - - - - 20
  • 23. Glucose, Method 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 4+ Negative Trace 1+ 2+ 3+ - - 10 10 - - - - 1 1 23 194 1 - - - 6 4 - - - 11 10 - - - - - 10 10 - - - - - - 26 2 - - - 1 6 18 3 - 1 - 2 87 2 1 1 - - 1 1 1 1 80 20 5 1 15 61 14 11 2 6 3 20 - - - 5 22 3 - - 191 28 1 - 1 4 2 - 5 2 2 10 7 122 14 244 34 9 11 294 3 128 33 2 4 26 12 17 1 3 1 7 21
  • 24. Glucose, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative 30-100 mg/dL 150-300 mg/dL 500* mg/dL >500 or ≥1000 or ≥2000 mg/dL 463 - - - - 54 3 - - - 171 - - - - 144 17 165 33 70 - - 1 - - 95 - - - - 323 - - - - 33 54 897 482 139 - 1 - 1 - - *Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL. 22
  • 25. Glucose, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative 30-100 mg/dL 150-300 mg/dL 500* mg/dL >500 or ≥1000 or ≥2000 mg/dL 462 1 - - - 56 1 - - - 171 - - - - 145 17 166 33 70 - - - - 94 - - - - 323 - - - - 33 54 897 481 138 1 - 1 1 1 - - *Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL. 23
  • 26. Glucose, Method 2 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual >500 or ≥1000 or ≥2000 mg/dL Negative 30-100 mg/dL 150-300 mg/dL 500* mg/dL - - 438 20 5 - - 20 35 2 - - 4 31 136 - 1 - 126 14 145 26 10 1 2 20 16 3 19 7 40 - - 22 1 72 - 1 290 28 3 1 7 3 - 1 7 5 1 15 10 231 273 41 14 29 583 178 54 3 14 71 24 44 *Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL. 24
  • 27. Reducing Substance CM-14 Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus Visual CM-15 Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus Visual CM-16 Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus Visual ¼% Negative (Trace) ½% ¾%* 1% ≥2% 203 1 - - - - 11 2189 1 - 1 2 1 ½% ¾%* 1% ≥2% ¼% Negative (Trace) 199 5 - - - - 11 2185 8 - - 1 - ½% ¾%* 1% ≥2% ¼% Negative (Trace) 2 4 11 5 49 133 12 12 39 2 239 5 1234 4 660 * Please note ¾% is not an appropriate response for the Bayer Clinitest, 2-drop method. 25
  • 28. Ketones, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small - - - - 10 10 - - - 1 44 - - - - 10 10 - - - - 10 - - - - 10 - - 5 22 1 1 - - - 1 1 3 9 16 12 - - - 6 13 1 3 - 4 1 - 29 2 7 26 38 96 26 Moderate Large
  • 29. Ketones, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small Moderate Large 10 10 - - - - 45 - - - - 10 10 - - - - 10 - - - - 10 - - - - 28 - - - - 10 18 15 - - - - 19 - - - - 60 40 102 - - 1 2 27
  • 30. Ketones, Method 1 CM-16* Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small Moderate Large 10 10 - - - - - 3 40 2 - 10 10 - - - - 10 - - - - 10 - - - - - 17 11 - - - 1 1 1 7 9 8 2 8 5 1 - 12 7 - - 5 4 64 40 22 24 14 11 7 1 2 7 1 1 4 * Specimen CM-16 was not graded due to lack of participant consensus. 28
  • 31. Ketones, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 2 - - 14 227 2 - - - 7 3 - - - - 2 26 - - - - 17 12 - 1 - 10 69 6 - 1 - 1 2 3 9 13 100 37 16 67 1 60 - - - - 2 31 4 - - - 65 160 1 2 - 1 - 15 1 - 5 1 265 3 22 4 16 16 152 13 228 43 1 2 111 5 29
  • 32. Ketones, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 245 - - - - - 10 - - - - - 28 - - - - - 29 - - - - - 86 - - - - - 104 97 26 82 - 1 - - - 37 - - - - - 225 - - - - - 21 18 438 16 362 51 - - 1 - - 30
  • 33. Ketones, Method 2 CM-16* Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - 3 228 12 2 - - 3 7 - - - 27 1 - - - - - - 28 1 - - - 48 35 4 - - 1 14 4 2 58 26 24 45 42 47 1 21 23 1 1 - - - 4 30 3 - 7 127 94 - - - 34 22 27 15 9 279 12 140 14 6 9 124 4 186 4 2 15 4 3 - * Specimen CM-16 was not graded due to lack of participant consensus. 31
  • 34. Ketones, Method 3 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative 5-10 mg/dL 1 - - 15-20 mg/dL 40 - 60 mg/dL 80 - 100 mg/dL 1 14 372 3 - - - 39 14 1 - 18 1 126 1 - - 1 - 4 5 2 9 1 2 - 125 12 136 19 - - 1 - - 86 - - 1 89 205 3 1 - 1 - 1 11 - 6 6 486 26 6 18 47 339 319 45 4 1 7 119 16 Negative 5-10 mg/dL 15-20 mg/dL 40 - 60 mg/dL 80 - 100 mg/dL ≥150 mg/dL 390 - - - 1 - 53 - - - - - 147 - - - - - 131 17 140 28 - - - - - 87 - - - - - 299 - - - - - 31 54 842 463 67 - - - - 1 1 - 32 ≥150 mg/dL
  • 35. Ketones, Method 3 CM-16* Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 5-10 mg/dL 15-20 mg/dL - 221 157 - - - 80 - 100 mg/dL ≥150 mg/dL 12 1 - 44 2 3 - 75 68 - 2 - 1 1 - 6 5 3 - 74 9 76 24 49 3 59 4 1 - 1 - - 1 9 75 2 - 9 172 111 2 - - 2 3 70 30 35 23 27 472 204 20 6 23 289 205 8 4 14 4 1 - - Negative * Specimen CM-16 was not graded due to lack of participant consensus. 33 40 - 60 mg/dL
  • 36. Bilirubin, Method 1 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace/Small Positive/Moderate Large 370 - - - 28 29 - - - 20 - - - 320 - - - 11 - - - 32 54 862 492 115 1 - 3 - 2 - Negative Trace/Small Positive/Moderate Large 370 - - - 27 29 - - - 20 - - - 320 - - - 11 - - - 32 53 865 492 115 - 1 - 1 - 34
  • 37. Bilirubin, Method 1 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace/Small 2 - 51 317 - - 10 13 17 16 - 1 4 15 2 1 162 153 1 - 6 4 3 1 2 - 4 3 640 8 8 28 51 225 481 106 35 Positive/Moderate Large
  • 38. Bilirubin, Method 2 CM-14 Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 208 - - - 2 - 10 - - - - - 11 11 - - - - - 10 - - - - - 10 - - - - - 27 - - - - - 100 10 83 22 90 - 1 - - - 32 - - - - - 207 - - - - - 20 15 375 16 300 66 - 1 - 1 - - 1 - 36
  • 39. Bilirubin, Method 2 CM-15 Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 210 - - - - - 10 - - - - - 11 11 - - - - - 10 - - - - - 10 - - - - - 27 - - - - - 99 10 83 22 91 - - 1 - - - 32 - - - - - 206 - - - - - 20 15 377 16 301 66 - - - - - 37
  • 40. Bilirubin, Method 2 CM-16 Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - - 1 3 - 57 149 - - - - 10 - - - - 1 11 10 - - - - - 10 - - - - - 10 - 4 - - - 23 - - 1 - 3 2 - 99 7 80 22 90 1 1 - - - - - 32 - - - 1 111 94 1 1 - - 1 - 3 264 7 1 5 16 15 112 9 298 57 1 4 38
  • 41. Bilirubin, Method 3 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 81 - - - - 111 16 132 27 - - - - 67 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 81 - - - - 111 16 131 27 - - 1 - - 67 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL - - 1 13 67 - - - 111 16 129 27 3 - - 1 - 66 - 39
  • 42. Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 1 CMP1-04 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-05 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-06 Method/Instrument Negative Trace/Small Positive/Moderate Large 28 - - - 146 - - - Negative Trace/Small Positive/Moderate Large 28 - - - 147 - - - Negative IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Trace/Small Positive/Moderate Large 1 - 10 16 2 25 113 6 Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 2 CMP1-04 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-05 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-06 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Negative Trace 1+ 2+ 3+ 4+ 17 - - - - - 61 - - 1 - - 1+ 2+ 3+ 4+ Negative Trace 17 - - - - - 62 - - 1 - - 1+ 2+ 3+ Negative Trace 4+ - - - 3 13 1 3 - 7 53 - - 40
  • 43. Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 3 CMP1-04 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-05 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-06 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 22 - - - - 25 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 22 - - - - 25 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL - - 22 - - 2 - 23 - - 41
  • 44. Blood or Hemoglobin, Method 1 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Marked Positive/Moderate Positive/Large Negative Trace/Small 1 2 197 159 - - - 40 1 2 124 29 - - - 24 24 - - - 18 1 - 8 302 1 - 2 6 38 57 3 32 51 842 418 143 Negative Trace/Small - 1 304 54 - - 6 34 1 2 121 32 - 1 - 24 23 - - - 18 1 - 9 301 1 1 - 1 1 - 3 8 38 86 9 29 48 840 386 139 42 Marked Positive/Moderate Positive/Large
  • 45. Blood or Hemoglobin, Method 1 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Marked Positive/Moderate Positive/Large Negative Trace/Small - 2 95 262 - - 2 38 - 2 92 62 - - 1 - 23 24 - - - 18 1 - 3 307 - 1 1 2 2 20 17 2 32 56 859 457 144 43
  • 46. Blood or Hemoglobin, Method 2 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 5+ - - - - 10 10 - - - - - 146 108 1 - - - - - 11 11 - - - - - - 10 - - - - - - 10 - - - - - 5 23 - - - - 1 5 27 - - - - 2 68 18 - - 1 1 - - - 7 6 10 7 10 101 32 14 18 47 - - - - - 13 19 4 1 - 1 5 224 2 - 1 - - 1 2 13 54 1 20 15 419 16 299 75 1 1 2 1 2 2 44
  • 47. Blood or Hemoglobin, Method 2 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 5+ - - - - 10 10 - - - - - 215 40 - - - - - - 11 11 - - - - - - 10 - - - - - - 10 - - - - - 22 6 - - - - 1 6 26 - - - - 2 66 20 - - - 1 - 8 4 11 8 11 100 31 14 18 47 - - - - - 11 21 4 1 - 1 6 222 2 - 1 1 - - 1 4 9 1 92 3 19 12 423 15 262 73 1 2 2 1 1 2 45
  • 48. Blood or Hemoglobin, Method 2 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 5+ - - - - 10 10 - - - - - 69 186 - - - - - - 11 11 - - - - - - 10 - - - - - - 10 - - - - - - 28 - - - - 1 2 30 - - - - 2 52 34 - - 1 1 - - 7 5 10 6 1 10 100 34 14 18 47 - - - - - 11 21 4 - - - 2 229 2 - 1 1 - - - 3 16 1 20 17 429 15 337 74 1 1 4 1 2 2 46
  • 49. Blood or Hemoglobin, Method 3 5 – 25 CM-14 CM-15 Method/Instrument Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status CM-16 Method/Instrument Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Negative Ery/µL Ery/µL Ery/µL 1 1 - - 1 2 1 - 106 16 139 33 64 - - - 71 - 1 2 8 30 29 50 – 150 250 Negative Ery/µL Ery/µL Ery/µL - - 1 2 1 108 17 138 34 63 1 - - 70 - 1 2 9 30 28 5 – 25 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status 250 5 – 25 Method/Instrument 50 – 150 50 – 150 250 Negative Ery/µL Ery/µL Ery/µL - - 1 2 1 - 107 16 139 34 64 - - - 71 1 1 2 2 30 34 47
  • 50. Blood or Hemoglobin, Method 4 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY ±0.03 mg/dL Negative 0.06 – 0.10 mg/dL 0.20 – 0.50 mg/dL ≥1.0 mg/dL - - - 31 30 - - - 2 10 - - - 10 8 0.06 – 0.10 mg/dL 0.20 – 0.50 mg/dL ≥1.0 mg/dL ±0.03 mg/dL Negative - - - 48 13 - - - 1 11 - - - 10 8 0.06 – 0.10 mg/dL 0.20 – 0.50 mg/dL ≥1.0 mg/dL ±0.03 mg/dL Negative - - - 10 51 - - - - 12 - - - 9 9 48
  • 51. Leukocyte Esterase, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Large Positive* - - - - 10 10 - - - 1 1 354 1 - - - - 10 10 - - - - - 10 - - - - - 10 - - - - - 37 - 1 - - - 140 11 1 - - 5 6 16 11 2 - - - - 4 14 - - 1 - 12 285 1 1 - 1 - 4 8 4 107 2 14 31 695 188 51 12 19 180 176 79 2 4 1 * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 49 Small Moderate
  • 52. Leukocyte Esterase, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small Moderate Large Positive* 10 10 - - - - - 357 - - 1 - - 10 10 - - - - - 10 - - - - - 10 - - - - - 33 2 2 - - - 151 1 - - - - 23 17 - 1 - - - 18 - - - - - 299 - - - - - 30 56 879 475 129 1 1 1 1 - 2 1 - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 50
  • 53. Leukocyte Esterase, Method 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small - - - - 10 10 - - - 3 3 350 1 - - - - 10 10 - - - - - 10 - - - - - 10 - - - - 1 36 - - - - 4 137 11 - - - 4 6 17 11 2 1 - - - 5 13 - - 1 - 96 201 1 1 1 1 1 4 15 38 7 11 46 456 403 76 18 3 401 4 38 5 6 31 9 2 1 1 * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 51 Moderate Large Positive*
  • 54. Leukocyte Esterase, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1+ 2+ 3+ 4+ Positive* - - 6 185 8 - - - - 4 6 - - - - - - 20 - - - - - - 16 - 1 - - - 2 83 1 - - - 1 3 106 29 8 70 3 59 13 17 1 - 1 - - - - 20 16 - - 1 - - 7 216 2 1 1 1 - 2 - 1 1 3 76 - 17 11 345 168 47 5 5 79 16 118 31 1 1 2 - - Negative Trace 1 * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 52
  • 55. Leukocyte Esterase, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 ** IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ Positive* 199 - - - 1 - - 10 - - - - - - 20 - - - - - - 12 2 3 - - - - 86 - - - - - - 111 89 21 90 - - - - - - 36 - - - - - - 224 - 1 - 1 - - 23 18 430 16 365 77 1 - - - 1 - - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. ** Specimen CM-15 for this peer group was not graded due to lack of participant consensus. 53
  • 56. Leukocyte Esterase, Method 2 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ Positive* - - - 7 185 8 - - - - 7 3 - - - - - 3 17 - - - - - - 16 - 1 - - - 3 82 1 - - - 2 1 20 105 29 7 61 2 59 13 9 1 - 1 1 - - - - 20 16 - - - - - 91 134 1 1 1 1 11 15 5 10 16 228 328 47 11 1 189 7 8 22 2 1 3 8 13 3 1 - - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 54
  • 57. Leukocyte Esterase, Method 3 25 75 or 100 Negative µL µL 1 - - 250 or 500 Positive* - 113 4 - - 30 1 - - - 27 - 1 - - 1 - 106 17 144 32 1 - - - 71 - - - - 12 - - - 17 19 14 6 - 75 or 100 Negative µL µL 250 or 500 116 - 28 ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Method/Instrument CM-15 µL 25 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status µL Positive* - 2 - 3 - - - 27 - - - - 107 17 144 33 - - 1 - - 71 - - - - 12 - - - - 31 25 - - - - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 55
  • 58. Leukocyte Esterase, Method 3 25 CM-16 Method/Instrument 75 or 100 Negative µL µL - - - ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status 250 or 500 µL Positive* - 115 3 - - 30 1 - - - 27 - - - 1 - 107 17 144 32 1 - - 2 69 - - - 3 9 - - 3 28 20 4 1 - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 56
  • 59. Nitrite CM-14 Method/Instrument Negative ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Positive 1 678 - 11 - 11 11 - 10 10 - 23 - 85 1 259 1 - 241 26 245 56 99 - 125 - 536 1 2 - 57 11 10 54 77 1339 18 861 210
  • 60. Nitrite CM-15 Method/Instrument Negative ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Positive 2 677 - 11 - 11 11 - 10 10 1 22 - 85 1 259 1 2 - 240 26 244 56 99 - 125 2 533 5 4 2 58 11 10 54 76 1333 18 859 208
  • 61. Nitrite CM-16* Method/Instrument Negative ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Positive - 11 10 3 675 10 1 - 11 11 - 10 10 22 1 17 68 23 237 225 23 193 54 83 15 3 53 2 16 108 15 - 536 1 2 8 2 11 95 53 75 1330 16 852 114 * Specimen CM-16 was not graded due to lack of participant consensus. 59
  • 62. Urobilinogen CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1.0 Negative 4.0 ≥8.0 or mg/dL or or 0.0 - 0.2 or 2.0/3.0 4.0/6.0 12.0 <2.0 mg/dL mg/dL mg/dL mg/dL mg/dL or or or or or <3.2 µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive ** 11 10 - - - - - 365 278 - 1 - - 11 - - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 23 5 - - - - 66 14 - - - - 170 81 - - - - 221 25 245 54 89 2 2 1 - - - - 118 - - - - - 486 3 - - - - 48 63 1167 17 719 165 5 1 1 1 3 - - 2 1 1 2 - ** Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 60
  • 63. Urobilinogen CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1.0 Negative 4.0 ≥8.0 or mg/dL or or 0.0 - 0.2 or 2.0/3.0 4.0/6.0 12.0 <2.0 mg/dL mg/dL mg/dL mg/dL mg/dL or or or or or <3.2 µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive ** 11 10 - - - - - 364 280 - - 1 - 11 - - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 23 5 - - - - 64 15 - - - - 168 83 - - - - 221 25 245 54 89 2 2 1 - - - - 118 - - - - - 488 1 - - - - 48 62 1170 17 720 167 5 1 - 1 3 - - - 1 - ** Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 61
  • 64. Urobilinogen CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1.0 Negative 4.0 ≥8.0 or mg/dL or or 0.0 - 0.2 or 2.0/3.0 4.0/6.0 12.0 <2.0 mg/dL mg/dL mg/dL mg/dL mg/dL or or or or or <3.2 µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive ** - - - 11 10 - - - 1 17 616 9 2 - - - - 11 - - - - 11 10 - - - - - 10 - - - - - 10 - - 1 - 6 21 - - - 1 1 4 69 5 - - 3 239 2 7 3 1 1 1 1 1 1 5 2 10 218 25 237 49 77 1 4 2 - - - - - 118 - - - 2 428 59 - 1 5 - 1 1 - 1 5 12 3 47 62 1163 5 723 162 3 2 1 ** Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 62
  • 65. Urine Sediment Photographs CMP-17 Case History CMP-17 through CMP-20 This urine sample is from a 37-year-old man with advanced kidney disease, admitted through the emergency room (ER) for lower abdominal discomfort and painful urination. Laboratory data include: specific gravity = 1.017, pH = 5.0; blood, leukocyte esterase, protein, glucose, ketones, and nitrite = positive. CMP Participants No. % Identification Granular cast 4393 96.8 Performance Evaluation Good The arrowed object is a granular cast as correctly identified by 96.8% of the participants. Urinary casts are cylindrical objects that form in the distal tubules and collecting ducts as a result of solidification of protein within the renal tubular lumen. Casts are sub-classified based on their matrix composition (hyaline, waxy), inclusions (granules, fat, hemosiderin), or cellular composition (white cells, red cells, renal tubular epithelial cells, bacteria). Granular casts as depicted in this image are a common finding in urine specimens. This cast is made up of plasma proteins from degenerated cellular products and may have a fine or coarse granular appearance that is often evenly dispersed throughout the cast. Most granular casts are not pathological; however, these casts can be seen in urine from individuals with renal disease. 63
  • 66. CMP-18 Urine Sediment Photographs CMP Participants No. % Identification Erythrocyte, mature 4463 98.4 Performance Evaluation Good The arrowed object is a red blood cell that is correctly identified by 98.4% of the participants. Red blood cells in wet preparations appear as pale yellow-orange discs that are usually about 7 to 8 μm in diameter. The appearance of red blood cells depends upon the age and condition of the urine specimen. Old hypotonic urine specimens make red blood cells appear as “ghost-like,” faint, colorless circles. Red blood cells in hypertonic urine samples can appear more crenated. Oil droplets can mimic red blood cells but the refractile nature of oil droplets is a helpful distinction. Crenated red cells may be confused with white blood cells, which unlike red blood cells have multilobated nuclei. Generally, only a small number of red blood cells are seen in urine (less than 3/HPF); however, increased numbers of red blood cells can be associated with kidney disease, inflammation, trauma, or bleeding disorders. 64
  • 67. CMP-19 Urine Sediment Photographs CMP Participants Identification Performance No. Evaluation 4377 Waxy Cast % 96.5 Good The arrowed image is a waxy cast which was correctly identified by 96.5% of the participants. Waxy casts are usually broad and stubby with a homogenous smooth and dense appearance. The ends are often blunted with well-defined parallel margins that may be serrated or notched which reflect its brittle nature. Waxy casts are thought to arise from the degeneration of cellular casts and are frequently associated with severe or progressive chronic renal disease. These waxy casts can be differentiated from hyaline casts due to their highly refractile nature. 65
  • 68. CMP-20 Urine Sediment Photographs CMP Participants No. % Identification Calcium oxalate crystals 4533 99.9 Performance Evaluation Good The arrowed objects are calcium oxalate crystals which were correctly identified by 99.9% of the participants. Calcium oxalate crystals can have various forms. The classic form is the dihydrate form, as depicted in this image, which appears as a colorless octahedron with the morphologic features of an envelope. The monohydrate form has an oval, elliptical, or dumbbell shape. Large numbers of oxalate crystals can be seen in chronic renal disease, ethylene glycol (antifreeze) toxicity, or in patients who consume foods rich in oxalic acid (ie, tomatoes, apples, asparagus, oranges, or carbonated beverages). Calcium oxalate crystals can cause renal calculi. George Girgis, MT Hematology and Clinical Microscopy Resource Committee 66
  • 69. Body Fluid Photographs Case History CMP-21 through CMP-26 The patient is a 38-year-old, immunocompromised man who presents with fever, shortness of breath, and nonproductive cough. Bronchioalveolar lavage (BAL) is performed and shows: total nucleated cells = 6100/μL (6.1 × 10 /μL) and RBC = 400/μL (0.4 × 10 /μL). Referees No. % CMP-21 Identification CMP Participants No. % Performance Evaluation Monocyte/macrophage 3 33.3 1083 43.5 Non-consensus Mesothelial cells 3 33.3 746 29.9 Non-consensus Macrophage containing hemosiderin (Siderophage) 1 11.1 180 7.2 Non-consensus Bronchial lining cell 1 11.1 156 6.3 Non-consensus The arrowed cell represents a monocyte/macrophage, as was correctly identified by 43.5% of the participants. Monocytes and macrophages represent a continuum on the mononuclear phagocytic series, with monocytes typically referring to cells circulating in the blood, while macrophages represent more mature forms that have undergone further differentiation after migration into tissues. Alveolar macrophages typically are the predominant cells in bronchoalveolar lavage fluid and have similar morphology to the macrophages seen in other body fluids. They have an eccentric round nucleus and abundant blue-grey cytoplasm, with small numbers of azurophilic granules, vacuoles, and may contain ingested material such as hemosiderin, RBCs or nucleated cells, microorganisms, or lipid. Cytoplasmic black carbon particles can also be observed in alveolar macrophages of smokers. Mature macrophages can sometimes be difficult to differentiate from mesothelial cells in some types of specimens. An important clue here that the cell is a macrophage and not a mesothelial cell is the specimen source, namely bronchoalveolar lavage. Mesothelial cells are lining cells of the peritoneal, pericardial, and pleural cavities, whereas the lining cells of the bronchial tree have a distinctly different appearance and are columnar and ciliated. When peritoneal, pericardial, and pleural fluids are being examined, distinguishing features of mesothelial cells that may be helpful in differentiating from macrophages include the biphasic cytoplasmic staining, with a lightly staining perinuclear area and a deeper blue periphery; the more pronounced surface membrane projections; and the presence of “windows” between mesothelial cells in clusters, which are clear spaces between individual cells. 67
  • 70. CMP-22 Body Fluid Photographs CMP Participants No. % 1653 Macrophage containing abundant small lipid vacuoles/droplets (Lipophage) Monocyte/macrophage 66.5 Educational 429 Identification Performance Evaluation 17.3 Educational Neutrophil/macrophage with phagocytized 133 5.3 Educational fungi Macrophage containing hemosiderin 70 2.8 Educational (Siderophage) The arrowed cell represents a lipophage, as was correctly identified by 66.5% of the participants. Identification as a monocyte/macrophage is also acceptable. A lipophage represents a macrophage containing numerous cytoplasmic small fat droplets, which result from ingestion of extracellular lipids, such as membranes from necrotic cells. Large numbers of lipophages can be observed in pleural fluid in the presence of chylothorax, or in cerebrospinal fluid following intrathecal chemotherapy or radiation therapy. 68
  • 71. CMP-23 Body Fluid Photographs Identification CMP Participants No. % Erythrocyte, mature 2481 99.3 Performance Evaluation Good The arrowed cell represents a mature erythrocyte, as was correctly identified by 99.3% of the participants. The presence of red blood cells (RBCs) in body fluids frequently indicates hemorrhage or traumatic contamination of the body fluid with peripheral blood. Their morphology in body fluids is similar to that observed in the peripheral blood: non-nucleated, round, with a zone of central pallor, although they can also appear crenated because of preservation artifact. 69
  • 72. CMP-24 Body Fluid Photographs Identification CMP Participants No. % Performance Evaluation Pneumocystis jirovecii 1821 73.4 Educational 167 6.7 Educational Bacteria - extracellular 94 3.8 Educational Macrophage containing hemosiderin (Siderophage) 73 2.9 Educational Degenerating cell, NOS 67 2.7 Educational Yeast/fungi, extracellular 47 1.9 Educational Stain precipitate The arrowed object represents Pneumocystis jirovecii, as correctly identified by 73.4% of the participants. Pneumocystis jirovecii (formerly Pneumocystis carinii) is an opportunistic fungal pathogen classified within phylum Ascomycota, which causes severe pneumonia in immunocompromised patients. The life cycle of the organism goes through a trophic and cystic form. Pneumocystis organisms are usually found within foamy amorphous material present within lung alveoli. Trophic forms can be visualized on Wright-Giemsa stained preparations and are typically 1-5 µm, pleomorphic, and contain a single nucleus. The wall of pneumocystis cyst forms does not stain on Wright-Giemsa, making this form more difficult to identify, although the presence of cyst forms may give the amorphous material a “honeycomb”-like appearance. Distinguishing Pneumocystis structures from artifact may be challenging and can be aided through the use of immunofluorescent monoclonal antibodies for direct detection in clinical specimens. 70
  • 73. CMP-25 Body Fluid Photographs Identification CMP Participants No. % Lymphocyte 2464 98.6 Performance Evaluation Good The arrowed cell represents a lymphocyte, as was correctly identified by 98.6% of the participants. Mature lymphocytes have round to oval nuclei with condensed chromatin and without visible nucleoli. The cytoplasm is typically scant, agranular, and basophilic. In body fluid specimens, particularly cerebrospinal fluid, centrifugation artifact can make mature lymphocytes appear to be larger than their counterparts in peripheral blood and to have visible nucleoli and more abundant cytoplasm. Care should be taken to distinguish such cytospin artifact from evidence of a hematolymphoid neoplasm. To the right of the lymphocyte, Pneumocystis jirovecii organisms are seen, including small trophic forms containing a single small nucleus, as well as several round lighter staining areas, representing cyst forms. 71
  • 74. CMP-26 Body Fluid Photographs CMP Participants No. % Identification Neutrophil, segmented or band 2463 98.6 Performance Evaluation Good The arrowed cell represents a neutrophil, as was correctly identified by 98.6% of the participants. Neutrophils are the most mature forms of the myeloid series with condensed nuclear chromatin and pale pink cytoplasm containing specific bluish granules. The nucleus is typically segmented with 3-5 distinct lobes connected by thin filaments. In the setting of infections, neutrophils can contain vacuoles, toxic granulation, Döhle bodies, or ingested microorganisms. In body fluid specimens, cellular degeneration may result in nuclear pyknosis and fragmentation. In some cases, pyknotic neutrophils may resemble nucleated red blood cells but can be correctly identified by the characteristics of the cytoplasm, which is more eosinophilic than that of nRBCs and may contain residual specific granules. Also of note is the Pneumocystis jirovecii present in the center of this image. 72
  • 75. Case Discussion: Pneumocystis in BAL This case illustrates an example of Pneumocystis jirovecii pneumonia in an immunocompromised patient, with evidence of Pneumocystis organisms in a bronchoalveolar lavage (BAL) specimen. Pneumocystis pneumonia (PCP) can occur in patients infected with human immunodeficiency virus (HIV) and CD4 T-lymphocyte counts <200/µL, where it is considered an acquired immunodeficiency syndrome (AIDS)-defining illness. PCP also can be seen in patients whose immune system is compromised by malignancies, chemotherapy, stem cell or solid organ transplantation, glucocorticoid use, particularly for rheumatologic conditions, or primary immune deficiencies. Because of the severity of Pneumocystis-associated disease, prompt treatment is required and prophylactic therapy is usually initiated in patients with low CD4 counts. Pneumocystis is classified in the fungal kingdom (phylum Ascomycota) based on gene sequence similarities with fungi, particularly in ribosomal RNA genes. Pneumocystis jirovecii refers to the human-specific form of the organism, which highlights the fact that unique Pneumocystis forms have been identified in various mammalian species with stringent host specificities. Pneumocystis is an obligate extracellular organism with a complex life cycle that involves sexual and asexual reproduction and two morphologic forms: trophic, which are usually haploid; and cystic, which can have 2-8 nuclei depending on the stage of development. Studying the genetics and life cycle of this pathogen has been challenged by inability to culture it ex vivo, ie, outside the host lung, although more recently advanced molecular and genomic techniques have been applied to elucidate its biology. According to the current understanding of PCP, acquisition of Pneumocystis occurs via the airborne route and person-toperson transmission. It is thought that immunocompetent individuals undergo asymptomatic infections and can therefore serve as a temporary reservoir for the organism. The clinical presentation of PCP differs between HIV-infected and non-HIV patients. In the context of HIV, PCP typically develops gradually, with low-grade fevers, progressive dyspnea, fatigue, and cough that is usually nonproductive and less commonly productive of clear sputum. In non-HIV patients, fulminant respiratory failure is common, requiring ventilatory support. Radiographic findings are similar in the two patient populations and characterized by bilateral diffuse interstitial infiltrates. High-resolution computed tomography (CT) findings of patchy or nodular ground-glass opacities are suggestive of PCP although not diagnostic. Given the relatively nonspecific clinical presentation and radiographic findings, the diagnosis of PCP depends largely on the laboratory identification of Pneumocystis, although that is somewhat limited by the inability to culture the organism. Microscopic identification of P. jirovecii is typically performed on BAL specimens obtained with bronchoscopy. While induced sputum can also be used and is less invasive, it is considered suboptimal due to decreased sensitivity and specificity compared to BAL, especially for patients receiving PCP prophylaxis. Lung biopsy tissue is also an appropriate diagnostic specimen, however, it is associated with high cost and invasiveness and is infrequently used. Various histochemical stains can be employed to detect P. jirovecii, but many of these conventional stains may be unable to simultaneously detect trophic and cystic forms. A recent study directly comparing four different staining techniques found that Grocott-Gomori methenamine silver stain (GMS) and Calcofluor white fungal stain (CW) have superior sensitivity compared to Diff-Quik staining (~ 75% vs. ~ 50%, respectively). In contrast, immunofluorescent monoclonal antibody staining can detect both life forms, providing the highest sensitivity of all microscopic techniques (> 90%), although it tends to be more costly, time consuming, and may be associated with a small decrease in specificity (~ 95% vs. >99% for the 3 conventional staining methods). Other methods have been developed recently for PCP diagnosis in order to increase the sensitivity of P. jirovecii detection and/or avoid the invasiveness of bronchoscopy. Various methods employing polymerase chain reaction (PCR) have been described and shown to have improved sensitivity compared to microscopy (94-100% 73
  • 76. depending on the genomic target). The disadvantage of such assays is that they may also detect P. jirovecii DNA in patients who are colonized by P. jirovecii but do not have associated pneumonia, which may lead to unnecessary treatment. Efforts have also been made to detect markers of P. jirovecii infection in serum, the most promising of which is β-D-Glucan (BDG) and may offer a noninvasive alternative to BAL. Although assays detecting serum β-D-Glucan have been shown to perform well in HIV-infected patients, the characteristics of such assays need to be further evaluated in different patient populations, particularly in the context of therapy. Martina Lefterova, MD, PhD Joan E. Etzell, MD, FCAP Hematology and Clinical Microscopy Resource Committee References: 1. Krajicek BJ, Limper AH, Thomas CF Jr. Advances in the biology, pathogenesis and identification of Pneumocystis pneumonia. Curr Opin Pulm Med. 2008;14:228-234. 2. Procop GW, Haddad S, Quinn J, et al. Detection of Pneumocystis jiroveci in respiratory specimens by four staining methods. J Clin Microbiol. 2004;42:3333-3335. 3. Thomas CF Jr., Limper AH. Current insights into the biology and pathogenesis of Pneumocystis pneumonia. Nat Rev Microbiol. 2007;5:298-308. 4. Tietjen PA. Clinical presentation and diagnosis of Pneumocystis infection in HIV-infected patients. In: Basow DS, ed. UpToDate. Waltham, MA: Wolters Kluwer Health; 2011. http://www.uptodate.com/contents/clinicalpresentation-and-diagnosis-of-pneumocystis-infection-in-hiv-infected-patients. Accessed January 9, 2013. 74