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Role of KMLTTB in HIV POC implementation

MINISTRY OF HEALTH Kenya Medical Lab Technicians and Technologists Board. Role of KMLTTB in HIV POC implementation. Bintiomar Tsala , Abdulatif ALI. Kenya; Point of Care testing. 1 st 90 ; Gap of 25%. Opportunities for POC.

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Role of KMLTTB in HIV POC implementation

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  1. MINISTRY OF HEALTH Kenya Medical Lab Technicians and Technologists Board Role of KMLTTB in HIV POC implementation BintiomarTsala, Abdulatif ALI

  2. Kenya; Point of Care testing • 1st 90; Gap of 25% Opportunities for POC While Kenya has a robust HIV lab network POCT has been identified to address her unmet needs of HIV EID and Viral load testing. Centralized system • 2nd 90; Gap of 20%

  3. Key thematic areas for POC implementation Key pillars that anchor POC implementation

  4. KMLTTB Function – Regulatory approvals Ministry of Health Legal Notice 113 (2011) Manufacturers of IVD products approached relevant programs directly without proper verifications Mandated KMLTTB Regulation of all IVDs intended for laboratory use in Kenya KMLTTB function

  5. Role of KMLTTB in POC implementation Main Registration of the POC devices Post-market surveillance Pre-distribution lot – to –lot validation

  6. Overview of POCsregistrationprocess Validation reportfromlab Training of ToTonPOC usability POC isreturned to manufacturer Duly filledregistrationform Registrationpayment 5 Recommendation to manufacturer/ Certificate of approval Submission of form & Dossier to KMLTTB Submission of POC to KMLTTB POC released to validatinglab

  7. Validation outcomes of the two POC Technologies WHO pre-qualified EID POC devices 1.Alere Q HIV 1/2Detect 2. Genexpert HIV 1 Qualassay The two equipment were duly registered

  8. Pre-distribution - lot to lot validation • NHRL • KMLTTB • KEMSA

  9. Post market surveillance • tool to consistently monitor the performance & quality of the reagent lots Provides information on the safety of the POC devices/cartridges after it is used in the general or local population post-distribution • periodic reviews & reports from end users • surveys on usability • Electronic POC records to pull out data to understand the trends related to operation of the equipment

  10. SWOT analysis of POC regulatory approval Opportunities Strengths Weakness Threats • Existent regulatory system established by law • Existent national validation laboratories • Accommodative national environment for multiple products to be validated and introduced into the market • Lack of reference assays for emerging technologies • National post-market surveillance policy framework for in-vitro diagnostic devices • Limited funding for post market surveillance . • Training the laboratory personnel across the country on usability • Implementation of a fast tracking process for registration of WHO prequalified, CE marked, FDA or any other internationally acceptable/recognized quality mark for POCT • Finalization of a national post-market surveillance policy and guidelines

  11. Best practices for POC regulatory approvals Memorandum of understanding with the validating labs Harmonized Stringent regulation policies in place Strategic information Successful validation of the POC equipment

  12. Conclusions There was no conflict of interest KMLTTB played a key role in the roadmap towards implementation of POC in Kenya Disclaimer Thank you

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