Bio-Oxford...Screeming Population

1. Prime Diagnostics of Brazil

2. Our commitment to be recognized as the most innovative, quality and
customer service oriented IVD Distributor Company in the Brazilian market, has
led us to a strategy that involves the ANVISA1 approval for all products and
equipments offered by Prime Diagnostics. Also all our suppliers are certified by
the main International Quality Management Systems (ISO9001, ISO13485, GMP -
Good Manufacturing Practices, etc .) which allows us to completely satisfy, and
even surpass, all market requirements.
(1) - ANVISA – National Agency of Sanitary Surveillance (linked to Brazilian Ministry of Health)

3. PRIME Branded products
Infectious Diseases Screening Tests

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● Prenatal Screening Tests
● General Screening Tests

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● History and the success of Newborn Screening
● 2002: Researchers and specialists developed the Q-Preven product line,
kits which used samples of human blood collected on S&S903 filter
paper for infectious diseases screening.

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1960, Robert Guthrie (1916- 1995)
Buffalo, NY

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Background
Guthrie published on 1963 the
results of a study involving
400.000 newborn samples in the
specialized magazine Pediatrics
(Guthrie R, Susi A. A Simple
Phenylalanine Method for
Detecting Phenylketonuria in
Large Populations of Newborn
Infants. Pediatrics, 1963 Sep;32:318-
343).

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Filter Paper in Brazil
1968 – Adopted by WHO/OMS (World Health Organization);
1976 – Introduced in Brazil
1992 – Mandatory throughout the entire Brazilian territory
2001 – Newborn Screening National Program

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SCREENING
Definition
Preventive care and educational initiatives for
pregnant women, general population and newborn
babies.

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SCREENING
Kit to collect samples
- Lancet
- Card (Filter Paper)

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SCREENING
Philosophy
● Concept: Screening for the masses;
● Target: 100% of all population;
● Methodology : fresh dried blood collected on
filter paper (ELISA).

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SCREENING
Objectives
● Facilitate the access to patients
● Identify the epidemiological profile.

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Sample Collecting Procedure for Filter Paper

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Punching the dried blood spot samples to ELISA Microplate

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Dried blood spot

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Dilute the samples

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Sample Shaking and Dilution

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Pipetting the Diluted Samples

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Equipments
• Semi-Automatic
ELISA microplates Reader

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Equipments
• Semi – Automatic
ELISA Microplate Washer

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Equipments
• Fully Automatic

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Equipments
• Puncher

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Advantages
Access Practical Prevention Innovation Economical

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Advantages
Access Practical Prevention Innovation Economical
• Rural epidemic control
• Laboratory infrastructure in
remote areas
• Filter paper brings the laboratory
structure from urbanized
cities to the most remote places

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Advantages
Access Practical Prevention Innovation Economical
• Easy method to collect the samples
- Whole blood
• Excellent solid support for antibodies
• Low volume and non-invasive
(50ul/spot)
•Transport (not infectious)
• Room temperature facilitates storage
procedures
• Excellent stability

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Advantages
Access Practical Prevention Innovation Economical
• Easy to diagnose
• Immediate treatment, decreasing the
number of critical cases
• Prevention Opportunities increase
• Lower Health Care costs

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Advantages
Access practicable Prevention Innovation Economical
• This methodology can be integrated
to preexisting programs:
• Rural and Indigen Population , etc...
• Family Health Programs
• Health Agents Programs

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Advantages
Access practicable Prevention Innovation Economical
• Cost Savings:
Transport
Storage
Equipment
Materials:
- Syringe / needle
- Tubes (to collect samples)
- Energy (no centrifuging procedure)

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Summary
1. Dried samples in filter paper are easy to
collect, transport and store.
2. Equivalent results when compared to the
alternative liquid method.
3. Excellent solution for areas with no or minimal
laboratory infrastructure

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SCREENING
Advantages related to the use of filter paper
LOGISTCS Serum Filter Paper
EXTRACTION Syringe Lancet
PREPARATION Centrifuge -
CONSERVATION Controled Temperature Ambient
(Ice)
SHIPMENT Styrofoam Envelop
(Ice)
PROFESSIONAL Specialized Simple Training

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SCREENING
CONVENTIONAL ELISA MODIFIED ELISA
Sample Sample
Serum/Plasma Filter Paper

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SCREENING
Infectious Diseases Kits
in Filter Paper
HIV CHAGAS
Syphilis HTLV
TOXO HCV
MEASLES HEPATITIS B
CMV

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PRENATAL SCREENING
“It is terrible when a child dies due to AIDS.
However it is worst when we know that it could
have been prevented.”
PEDIATRIC AIDS FOUNDATION