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 Testing Offered In PEPFAR-Supported Countries Between 2004-2013

4. Early Infants Diagnosis
Performance of Laboratories enrolled in Proficiency Testing for PCR-based
Early Infants Diagnosis
R2=0.40, P=0.003
This figure shows the significant increase in laboratories scoring a perfect 100% at each testing cycle
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
Policy Framework for Point of Care Testing
Foundation for Increased Uptake, Coverage, and Impact of QA for POC Testing
Guidance for Assuring the Accuracy of Point of Care Testing
Developing intervention strategies to achieve objectives

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
“ 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
Appendix 1
Certification Assessment checklist for initial training
Appendix 2
The Stepwise Process for Improving the Quality of HIV-Related Point-of-Care-Testing (SPI -POCT) checklist
Appendix 3
Example of Generic Standard Operating Procedures (SOPs) for Point of Care testing
Appendix 4
Job Aides for RDT and POC CD4
Appendix 5
Standardised protocol for coordination of proficiency testing (PT) panels program at a national laboratory
Appendix 6
Standardized Logbook HIV RDT and POC CD4
Appendix 7
Test reporting form
Appendix 8
Performance report for Equipment-based CD4 POC testing
Appendix 9
Country Modelling for set up of Quality Assurance

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

17. Organization of the SPI-POCT checklist
Section
Points
Section 1
HIV Rapid Testing Sites 56
Section 2
HIV Rapid Testing Personnel 11
Section 3
Document Control 4
Section 4
Personnel and Competence Assessment 5
Section 5
Quality Management System 6
Section 6
Specimen Handling and Processing
Section 7
Pre-testing, Testing and Post-testing Phases 23
Section 8
Test Results Reporting 3
Section 9
Section 10
Equipment
Section 11
Safety 8
Section 12 Section 13
Confidentiality and Conflict of Interest
Procurement and Supply 2

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

21. Special Considerations Boxes
Special Considerations for HIV Testing and Counseling
Area
Considerations for Programs
POC tests currently used or in the pipeline for this program
HIV Rapid Diagnostic Tests (RDTs)
List of common RDTs currently approved and used by countries can be found via the following links:
WHO PQ List:
USAID Waiver List:
POC CD4 machines are also used to determine CD4 counts for HIV positive persons and facilitate linkage to care
In the pipeline device free POC CD4 tests, POC viral load testing
Settings in which POC tests are used and operators in this program
POC tests are used in facility-based settings including ANC, TB, and STI clinics, outpatient departments and inpatient wards and co-located and stand-alone VCT sites. POC tests are also used in a wide range of community-based settings including mobile units, tents, workplace, homes, schools, etc.
POC HIV rapid tests are conducted by laboratorians, trained health care providers, and lay counselors. Several countries also have over the counter RDTs for the purpose of self-testing.
Challenges associated with POCT in this program
Adequate training including refresher trainings for staff performing POC HIV rapid tests
Adequate mentoring for new staff and ongoing supervision for all staff to monitor and ensure quality of testing
Proper documentation incorporated into HTC or stand-alone registers for monitoring performance of tests kits and the individual performing them.
Focus on quantity (number of persons tested) instead of quality (did individual receive correct result).
Adequate QA procedures including proficiency testing to monitor skills of tester, retesting of positive patients to ensure correct test result prior to initiating treatment, post-marketing surveillance to identify problems with test kits, and follow-up at poor performing test sites with corrective actions to improve the quality of testing.
Flexible algorithms and functioning supply chain management systems to deal with and prevent stock outs of test kits and supplies
Providers adhering to SOPs, particularly in settings with limited human resources and high patient volume
National policies to support implementation of quality assurance efforts of POC HIV rapid tests.
PMTCT
Paediatrics
STIs TB
HTC
Hepatitis

22. Acknowledgement
Angelii Abrol Jessica Markby Pam Bachanas Tseyhanesh Messele Stephanie Behel Fausta Mosha Sergio Carmona Jean-Bosco Ndihokubwayo Dana Duncan John Nkengasong Yen Duong Bharat Parekh Paula Fernandes Rosanna Peeling Peter Funjungo Trevor Peter Vincent Habiyambere Willy Urassa Mireille Kalou Lara Vojnov Jonathan Lehe Clement Zeh