1. 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

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
The process has taken into consideration PLHIV or at risk of HIV (HEI) as the central beneficiaries of POC.
SOC has helped the country achieve “access to HIV diagnostics” with several great achievements and some recognized challenges like delays in TAT for testing or for receiving results.
POC intends to complement the SOC in strengthening systems for HIV diagnostics but also contribute to the country’s “Results-4-life” initiative where the intention is to increase “Access to results” for timely clinical interventions

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
Pre-distribution lot – to –lot validation
Registration of the POC devices
Post-market surveillance

6. Overview of POCs registration process
Training of ToT on POC usability
Validation report from lab
POC is returned to manufacturer
Duly filled registration form
Registration payment 5
Recommendation to manufacturer/ Certificate of approval
Submission of form & Dossier to KMLTTB
Submission of POC to KMLTTB
POC released to validating lab

7. Validation outcomes of the two POC Technologies
WHO pre-qualified EID POC devices 1.Alere Q HIV 1/2 Detect
2. Genexpert HIV 1 Qual assay
Parameter
Alere Q
GeneXpert
Sensitivity
97.6%
99.1%
Specificity
100%
98.9%
PPV
NPV
97.0%
98.1%
Kappa
0.966
0.987
Errors
13.6%
4.2%
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
surveys on usability
periodic reviews & reports from end users
Electronic POC records to pull out data to understand the trends related to operation of the equipment
Provides information on the safety of the POC devices/cartridges after it is used in the general or local population post-distribution

10. SWOT analysis of POC regulatory approval
Strengths
Existent regulatory system established by law
Existent national validation laboratories
Accommodative national environment for multiple products to be validated and introduced into the market
Threats
Limited funding for post market surveillance .
Training the laboratory personnel across the country on usability
Weakness
Lack of reference assays for emerging technologies
National post-market surveillance policy framework for in-vitro diagnostic devices
Opportunities
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 Disclaimer Thank you There was no conflict of interest
KMLTTB played a key role in the roadmap towards implementation of POC in Kenya
Disclaimer
There was no conflict of interest
Thank you