update of cdc/who guidance on quality assurance for hiv-related point-of-care testing john...
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Update of CDC/WHO Guidance on Quality Assurance for HIV-Related Point-Of-Care Testing
John Nkengasong, PhD
Associate Director of Laboratory ScienceDivision 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
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2004 2005 2006 2007 2008 2009 2010 2011 2012 20130
10
20
30
40
50
60
70
1.93.7
7.2
12.7
21.6
28.5
32.8
40.5
49.0
57.7
Mill
ions
HIV Testing Offered In PEPFAR-Supported Countries Between 2004-2013
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2006
-2
2006
-3
2007
-1
2007
-2
2007
-3
2008
-1
2008
-2
2008
-3
2009
-1
2009
-2
2009
-3
2010
-1
2010
-2
2010
-3
2011
-1
2011
-2
2011
-3
2012
-1
2012
-2
2012
-3
60
70
80
90
100
Test Cycle
Perc
ent
R2=0.40, P=0.003
Performance of Laboratories enrolled in Proficiency Testing for PCR-based
Early Infants Diagnosis
Source - Garcia et al. JCM 2014
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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---”
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Elements of Disruptive Innovations:
----- Cheaper, Simpler, More Convenient Products Or Services That Start By Meeting
The Needs Of Less-demanding Customers----
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New HIV-Related Point of Care Testing Guidance
GUIDELINESfor Assuring the Accuracyand Reliability ofPOINT of CARE TESTING
National Policy Guidelines on
Implementing Quality-Assured
Point of Care Testing
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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
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Cycle of Implementing QA
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Phase I:Plan HIV-related POCT Quality Assurance
1. Engage Leadership
2. Establish a national QA coordination team
3. Define roles and responsibilities
4. Define Standards
5. Situational Analysis
6. Select and Assess Sites
7. Develop Implementation plan
8. Develop Policies
9. Plan financial and human resourcesDefine
Plan
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Phase II:Implement Quality Assurance for POCT
1. Develop and Implement Training and
Certification
2. Conduct Site Supervision and Drive
Accreditation
3. Implement Process Control
4. Generate QA-related Documentation
5. Strengthen Logistics for QA Monitor
Implement
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Phase III: Sustain Quality Assurance for POCT
1. Plan and allocate resources for the long term
2. Increase country ownership
3. Implement sustainability-focused monitoring and
evaluation programmes
4. Improve advocacy
5. Encourage social entrepreneurship: Q-Corp
Improve
Evaluate
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Response Rate and Performance of Pilot Site on Proficiency Testing Using Q-Corp (N=50)
92%
8%
Total Reported Total Not Reported
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“ 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
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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
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Immunology & Technology
Stepwise Process for Improving the Quality of HIV-Related Point-of-Care-Testing (SPI-POCT)
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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 6
Section 7 Pre-testing, Testing and Post-testing Phases 23
Section 8 Test Results Reporting 3
Section 9 Test Results Reporting 5
Section 10 Equipment 4
Section 11 Safety 8
Section 12 Section 13
Confidentiality and Conflict of InterestProcurement and Supply
23
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Score of HIV Rapid Test Pilot Sites Using SPI-POCT Checklist (N=69)
88%
12%
No Recognition Level 1 Level 2 Level 3
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PMTCTPaediatricsSTIsTBHTCHepatitis
Special Considerations BoxesSpecial Considerations for HIV Testing and Counseling
Area Considerations for ProgramsPOC 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:o WHO PQ List: http://apps.who.int/prequal/info_general/documents/annual_reports/
2013/PROGRESS_REPORT_WHO-PQP_June2013.pdfo 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.
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Angelii Abrol Jessica MarkbyPam Bachanas Tseyhanesh MesseleStephanie Behel Fausta MoshaSergio Carmona Jean-Bosco NdihokubwayoDana Duncan John NkengasongYen Duong Bharat Parekh Paula Fernandes Rosanna PeelingPeter Funjungo Trevor PeterVincent Habiyambere Willy UrassaMireille Kalou Lara VojnovJonathan Lehe Clement Zeh
Acknowledgement