Prime Diagnostics provides infectious disease screening programs for large populations. They offer automated testing equipment, technical assistance, sample collection kits, training, reagents, and a web-based results program. Their approach uses dried blood samples collected on filter paper, which allows for easy, non-invasive collection and transport of samples from remote areas without laboratory infrastructure. This methodology facilitates large-scale screening of populations to identify infectious diseases early and begin treatment or prevention efforts.

1. Prime Diagnostics
Screening Program

2. Our commitment to being recognized as the most innovating, quality and consumer-
oriented distribution company of in vitro diagnostics products of Brazilian and
international markets, leads us to a strategy that includes the approval of ANVISA¹ on all
equipment and products offered to the market by Prime Diagnostics.
Our suppliers have the main international certifications (ISO9001, ISO13485, GMP-Good
Manufacturing Practices, etc.), fact that allows us to satisfy completely, or even exceed,
the requirements of the market.
(1) - ANVISA – Agência Nacional de Vigilância Sanitária (Vinculada ao Ministério da Saúde) (National Health
Surveillance Agency (linked to the Ministry of Health)
Mission

3. 21
● General Population Screening Tests
● Hepatitis B
● Hepatitis C
● Syphilis
● HIV
Our Business
Human blood samples collected on
filter paper S&S 903

4. ● Concept: Screening of large populations;
● Objective: 100% of the entire population;
● Methodology: Sample of dried blood collected on paper
filter (ELISA).
Business Philosophy
Aiming at:
Facilitating access to patients
Identifying epidemiological profile

5. Procedure for collecting blood on paper filter
See attached sample

6. Access Practicality Prevention Innovation Economy
Benefits

7. Access Practicality Prevention Innovation Economic
• Internalization of the Epidemic
• Limited need of laboratory infrastructure in remote areas
• Paper filter takes the laboratory structure of urban
centers that are difficult to access.
Benefits

8. • Easy method of sample collection
-Total blood
•Great solid support for antibodies
•Low volume and little invasive
•(50ul/spot)
•Transport (non-infectious)
• Easy storage at room temperature
• great stability
Access Practicality Prevention Innovation Economic
Benefits

9. Access Practicality Prevention Innovation Economic
•Facilitates the diagnosis and consequently:
• Immediate treatment and reduction of
severe cases
• Increasing opportunities of
prevention
• Decrease in costs with
assistance
Benefits

10. Access Practicality Prevention Innovation Economic
• This methodology can be integrated:
•Urban, rural and remote population
•Family health program
Benefits

11. Benefits
Access Practicality Prevention Innovation Economy
• Cost Savings
Transportation
Storage
Equipment
Material
- Syringe needle
-Collection tubes
- Energy (no spin)

12. Logistics Serum Paper Filter
Extraction Syringe Lancet
Preparation Centrifugal machine -
Conservation
Controlled Temperature
(Ice)
Environment
Transportation
Polystyrene
(Ice) Envelope
Professional Professionals Simple Training
The Benefits of Paper Filter vs. the Serum Method

13. 1. Samples of dried blood on filter paper are easy to collect, carry and store.
2. Results equivalent to those obtained using the alternative method of test on
serum.
3. Excellent solution for areas without structure, or with precarious laboratory
structure.
4. Studies conducted by Brazilian institutions showed that, unlike the
collection method on needles, dried blood samples on paper filter remain
keep their properties preserved at extreme temperature conditions as
51°C, even when combined with high humidity.
Summary

14. HIV infection in the population is a growing
problem, especially in developing countries
hit by the AIDS epidemic.
The most frequent way of a child to
acquire HIV infection is through his/her
mother during pregnancy, at birth or
through breastfeeding.
The Importance of Prevention

15. In the 21st century, the HIV epidemic continues out
of control in many countries of the world. The Joint
United Nations Program on HIV/AIDS (UNAIDS)
estimates that 40 million people would be living with
HIV/AIDS, five million are infected every year, of
which three million would be children; of these, 500
thousand children would die as a result of the
infection and 700 thousand would have acquired
new infections only that year, many of them taken to
death before reaching adolescence.
The Importance of Prevention

16. Whatever the disease, it is always better to identify it in the pre-
symptomatic phase or in its early stages. This is the reason why the
programs aimed at the prevention and early diagnosis of various
diseases are the main objectives of current health initiatives. The main
purpose of these educational and prevention initiatives is to provide all
the resources necessary to disclose the information required for the
reduction of infection and mortality rates.
For example, the treatment of syphilis, a disease that can cause
blindness or death in neonates, can be accomplished with a single dose
of Benzathine Penicillin in primary cases, or up to 3 doses (one per
week), in cases of secondary or latent syphilis.
The Importance of Prevention

17. These initiatives can be applied to:
• General Screening Programs: For men and women in screening
diseases, such as AIDS, Syphilis and Hepatitis B and C.
The Importance of Prevention

18. The importance of diagnostic tests for the detection of infectious diseases,
has been widely disclosed around the world.
Programs with this scope of coverage, given their magnitude, only would be
possible to be implemented with the use of paper filter for the collection of
samples.
The Importance of Prevention

19. Infectious Disease Screening Program for the Population
What Prime Provides:
Prime Diagnostics has been operating in
the Brazilian market for more than five
years, and has extensive knowledge and
experience in the implementation,
management and control of population
screening programs intended for the
detection of infectious diseases.

20. Infectious Disease Screening Program
What Prime Provides:
1-Automated and/or semi-automated equipment:
High-tech equipment for the processing of results properly
certified at the major world sanitation control agencies such as the FDA and CE.
All equipment will be transferred under the lending scheme (commodato),
without additional cost to the program.
2 - Technical Assistance for the maintenance and repair of equipment.
Alternatives to
1 - Automated and/or semi-automated equipment:
2 – Technical Assistance
Alternative consists of hiring a laboratory to conduct the tests and the same will be paid
by PRIME.

21. Infectious Disease Screening Program for the Population
What Prime Provides:
4- Collection kit
All the material necessary to the collection of blood samples (model attached).
1 - Lancet
2- Sachet Silica
3- Sachet Alcohol
4– Paper filter
5– Collecting card
6- Manual
7- Small envelope
8- Larger envelope

22. Infectious Disease Screening Program for the
Population
• 5 - Operational Training of Sample Collection:
Training of multipliers of the process in relation to the care
and use of the material provided for the collection, storage,
handling and transport of samples.

23. Infectious Disease Screening Program for the Population
What Prime Provides:
6 – Chemical and Biological Reagents: Reagents needed for the processing of samples,
tested and approved by international agencies of sanitary control.

24. What Prime Provides:
7 - Web-based management program:
Program for remote access to web-based results, with access protected by individual
password. (model attached)
Login l (lowercase L) 970
Password: bio970
Infectious Disease Screening Program for the Population
See example attached

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35. APPROVAL IN SOUTH AFRICA

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