Update of CDC/WHO Guidance on Quality Assurance for HIV-Related Point-Of-Care Testing

1. Update of CDC/WHO Guidance on Quality Assurance for HIV-Related Point-Of-Care Testing John Nkengasong, PhD Associate Director of Laboratory Science Division of Global HIV/AIDS, Center for Global Health Center for Disease Control and Prevention WHO Satellite Session – Assuring the Quality of Diagnostics used at POT: Pre-Market Assessment and Post-Market Surveillance July 23, 2014 Center for Global Health

3. HIV TestingOfferedIn PEPFAR-Supported Countries Between 2004-2013

4. Performance of Laboratories enrolled in Proficiency Testing for PCR-based Early Infants Diagnosis R2=0.40, P=0.003 Source - Garcia et al. JCM 2014

5. Need for Disruptive Innovation To Ensure Quality of HIV-Related POCT “ ---Many of the most powerful innovations that disrupted other industries did so by enabling a larger population of less-skilled people to do in a more convenient, less expensive setting things that historically could be performed only by expensive specialists in centralized, inconvenient locations---”

6. Elements of Disruptive Innovations:----- Cheaper, Simpler, More Convenient Products Or Services That Start By Meeting The Needs Of Less-demanding Customers----

7. New HIV-Related Point of Care Testing Guidance GUIDELINES for Assuring the Accuracy and Reliability of POINT of CARE TESTING National Policy Guidelines on Implementing Quality-Assured Point of Care Testing

8. Guidance for Assuring the Accuracy of Point of Care Testing Foundation for Increased Uptake, Coverage, and Impact of QA for POC Testing Policy Framework for Point of Care Testing

9. Cycle of Implementing QA

10. Phase I:Plan HIV-related POCT Quality Assurance Engage Leadership Establish a national QA coordination team Define roles and responsibilities Define Standards Situational Analysis Select and Assess Sites Develop Implementation plan Develop Policies Plan financial and human resources Plan Define

11. Phase II:Implement Quality Assurance for POCT Develop and Implement Training and Certification Conduct Site Supervision and Drive Accreditation Implement Process Control Generate QA-related Documentation Strengthen Logistics for QA Implement Monitor

12. Phase III: Sustain Quality Assurance for POCT Plan and allocate resources for the long term Increase country ownership Implement sustainability-focused monitoring and evaluation programmes Improve advocacy Encourage social entrepreneurship: Q-Corp Evaluate Improve

13. Response Rate and Performance of Pilot Site on Proficiency Testing Using Q-Corp (N=50)

14. “ I have been impressed with the urgency of doing. Knowing is not enough; we must implement. Being willing is not enough; we must do—” – Leonardo Da Vinci

15. Appendices

16. Immunology & Technology Stepwise Process for Improving the Quality of HIV-Related Point-of-Care-Testing (SPI-POCT)

17. Organization of the SPI-POCT checklist

20. Score of HIV Rapid Test Pilot Sites Using SPI-POCT Checklist (N=69)

21. PMTCT Paediatrics STIs TB HTC Hepatitis Special Considerations Boxes

22. AngeliiAbrolJessica Markby Pam BachanasTseyhaneshMessele Stephanie BehelFaustaMosha Sergio Carmona Jean-BoscoNdihokubwayo Dana Duncan John Nkengasong Yen Duong Bharat Parekh Paula FernandesRosanna Peeling Peter FunjungoTrevor Peter Vincent HabiyambereWilly Urassa Mireille Kalou Lara Vojnov Jonathan LeheClement Zeh Acknowledgement