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

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

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

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

GUIDELINESfor Assuring the Accuracyand Reliability ofPOINT of CARE TESTING

National Policy Guidelines on

Implementing Quality-Assured

Point of Care Testing

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

Cycle of Implementing QA

Phase I:Plan HIV-related POCT Quality Assurance

1. Engage Leadership2. Establish a national QA coordination team3. Define roles and responsibilities4. Define Standards 5. Situational Analysis6. Select and Assess Sites7. Develop Implementation plan8. Develop Policies9. Plan financial and human resourcesDefine

Plan

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

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

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

92%

8%

Total Reported Total Not Reported

“ 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

4Job 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)

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

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

88%

12%

No Recognition Level 1 Level 2 Level 3

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.

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