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Apresentação Prime - INGLÊS - programa de triagem (10) ALTERAÇÕES1.ppt (1.103)

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Apresentação Prime - INGLÊS - programa de triagem (10) ALTERAÇÕES1.ppt (1.103)

  1. 1. Prime Diagnostics Screening Program
  2. 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. 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. 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. 5. Procedure for collecting blood on paper filter See attached sample
  6. 6. Access Practicality Prevention Innovation Economy Benefits
  7. 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. 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. 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. 10. Access Practicality Prevention Innovation Economic • This methodology can be integrated: •Urban, rural and remote population •Family health program Benefits
  11. 11. Benefits Access Practicality Prevention Innovation Economy • Cost Savings Transportation Storage Equipment Material - Syringe needle -Collection tubes - Energy (no spin)
  12. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  25. 25. RECORDS AT ANVISA
  26. 26. RECORDS AT ANVISA
  27. 27. RECORDS AT ANVISA
  28. 28. RECORDS AT ANVISA
  29. 29. RECORDS AT ANVISA
  30. 30. RECORDS AT ANVISA
  31. 31. RECORDS AT ANVISA
  32. 32. RECORDS AT ANVISA
  33. 33. RECORDS AT ANVISA
  34. 34. RECORDS AT ANVISA
  35. 35. APPROVAL IN SOUTH AFRICA
  36. 36. APPROVAL IN SOUTH AFRICA
  37. 37. APPROVAL IN SOUTH AFRICA
  38. 38. APPROVAL IN SOUTH AFRICA

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