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

HIV Testing Offered In PEPFAR-Supported Countries Between 2004-2013

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

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---”

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

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  

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

Cycle of Implementing QA

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

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

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

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

“ 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

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

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

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

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

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: http://apps.who.int/prequal/info_general/documents/annual_reports/2013/PROGRESS_REPORT_WHO-PQP_June2013.pdf USAID Waiver List: http://www.usaid.gov/sites/default/files/documents/1864/hiv_tests.pdf 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

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