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World Health Organization   International Biological   Standards Elwyn Griffiths Biologics and Genetic Therapies  Directorate
WHO’S BIOLOGICAL  STANDARDIZATION PROGRAMME ,[object Object],[object Object]
WHO’S BIOLOGICAL STANDARDIZATION PROGRAMME     ,[object Object],[object Object],[object Object]
FIRST BIOLOGICAL ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
INSULIN STANDARD ,[object Object],[object Object],[object Object],[object Object]
WHO Standard Setting Process ,[object Object],[object Object],[object Object]
WHO Laboratories and    Collaborating Centres ,[object Object],[object Object],[object Object],[object Object]
Collaboration ,[object Object],[object Object],[object Object],[object Object]
Types of WHO biological reference materials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Types of WHO biological reference materials ,[object Object],[object Object],[object Object],[object Object]
Examples of WHO Standards  relevant to  in vitro  diagnostics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Biologicals -     What’s the Problem? ,[object Object],[object Object],[object Object],[object Object]
Biologicals –     What’s the Problem? ,[object Object],[object Object]
WHO biological reference    materials  ,[object Object],[object Object]
Use of WHO International    Reference Materials ,[object Object],[object Object]
Biotechnology Derived Products ,[object Object],[object Object],[object Object],[object Object]
Regulatory Developments in standardisation ,[object Object],[object Object],[object Object]
Regulatory Developments in standardisation ,[object Object],[object Object]
ISO requirements for reference materials   ,[object Object],[object Object],[object Object]
ISO requirements for reference materials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Biological Situation ,[object Object],[object Object],[object Object]
Biological Situation ,[object Object]
ISO requirements for reference materials ,[object Object],[object Object]
International  Consultations –    on in vitro diagnostics ,[object Object],[object Object]
International  Consultations –    on in vitro diagnostics ,[object Object],[object Object]
International  Consultations –    on  in vitro  diagnostics ,[object Object],[object Object],[object Object]
Preparation, characterisation and establishment of WHO biological reference preparations ,[object Object],[object Object],[object Object]
Recommendations not Guidelines ,[object Object],[object Object],[object Object]
New   Recommendations ,[object Object],[object Object],[object Object]
New   Recommendations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New   Recommendations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New   Recommendations ,[object Object],[object Object]
New   Recommendations ,[object Object]
Assessment of need formalized ,[object Object],[object Object],[object Object],[object Object]
European Commission – Common Technical Document ,[object Object],[object Object]
European Commission – Common Technical Document ,[object Object],[object Object]
Keeping Pace with Developments ,[object Object],[object Object]
WHO Biologicals  Field ,[object Object],[object Object],[object Object],[object Object]
WHO Consultation June 2003 ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],prEN/ISO 17511  WHO
Calibration of the current International Reference Preparation  for TSH Deviation of any assay result from the  mean is composed of two elements;  the assay imprecision, and the bias: The WHO multi-method approach, by  including all assays, seeks to average out, and therefore eliminate the bias  effect. The WHO approach will provide an  estimate which is “accurate” but not  “ precise” The “reference-method approach will provide an estimate which may be “precise”, but not  “ accurate” Method bias, and single method vs multi method calibration
Single or multi-method calibration studies ,[object Object],[object Object]
To measure in activity (IU) or content (SI units)? ,[object Object],[object Object]
The case of the drifting hepatitis B nanogram ,[object Object],[object Object],[object Object],[object Object]
Drift in the HBsAg “ng”
Choice of units ,[object Object],[object Object]
Assignment of uncertainty ,[object Object],[object Object]
Calibration approach ,[object Object]
Calibration approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Value assignment approach ,[object Object]
Value assignment approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Next steps concerning uncertainty ,[object Object],[object Object],[object Object],[object Object],[object Object]
Other recommendations from June 2003 meeting ,[object Object],[object Object]
Conclusions from June meeting ,[object Object]
Conclusions from June meeting ,[object Object]
 

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Biological standardisation programme who

  • 1. World Health Organization International Biological Standards Elwyn Griffiths Biologics and Genetic Therapies Directorate
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  • 41. Calibration of the current International Reference Preparation for TSH Deviation of any assay result from the mean is composed of two elements; the assay imprecision, and the bias: The WHO multi-method approach, by including all assays, seeks to average out, and therefore eliminate the bias effect. The WHO approach will provide an estimate which is “accurate” but not “ precise” The “reference-method approach will provide an estimate which may be “precise”, but not “ accurate” Method bias, and single method vs multi method calibration
  • 42.
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  • 45. Drift in the HBsAg “ng”
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