A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned from the Population-based HIV Impact Assessment Project

Details

• Alternative Title:
  J Acquir Immune Defic Syndr
• Personal Author:
  Patel, Hetal K. ; Duong, Yen T. ; Birhanu, Sehin ; Dobbs, Trudy ; Lupoli, Kathryn ; Moore, Carole ; Detorio, Mervi ; Sleeman, Katrina ; Manjengwa, Julius ; Wray-Gordon, Floris ; Yavo, Daniel ; Jackson, Keisha ; Domaoal, Robert A. ; Yufenyuy, Ernest ; Vedapuri, Shanmugam ; Ndongmo, Clement ; Ogollah, Francis ; Dzinamarira, Tafadzwa ; Rubinstein, Paul ; Sachathep, Karampreet K ; Metz, Melissa ; Longwe, Herbert ; Suzue, Saito ; Voetsch, Andrew C. ; Parekh, Bharat
• Description:
  Background:
  
  Conducting HIV surveys in resource-limited settings is challenging due to logistics, limited availability of trained personnel, and complexity of testing. We describe procedures and systems deemed critical to ensure high-quality laboratory data in the Population-Based HIV Impact Assessments (PHIA), large-scale household (HH) surveys.
  
  Methods:
  
  Laboratory professionals were engaged in every stage of the surveys, including protocol development, site assessments, procurement, training, quality assurance, monitoring, analysis, and reporting writing. A tiered network of HH, satellite, and central laboratories, accompanied with trainings, optimized process for blood collection, storage, transport, and real-time monitoring of specimen quality and test results at each level proved critical in maintaining specimen integrity and high-quality testing. A plausibility review of aggregate merged data was conducted to confirm associations between key variables as final quality check for quality of laboratory results.
  
  Results:
  
  Overall, we conducted hands-on training of 3,355 survey staff across 13 surveys with 160 to 387 personnel trained per survey on biomarker processes. Extensive training and monitoring demonstrated that overall, 99% of specimens had adequate volume and 99.8% had no hemolysis indicating high-quality. We implemented quality control and proficiency testing for testing, resolved discrepancies, verified >300 PIMA instruments and monitored user errors. Aggregate data review for plausibility further confirmed high quality of testing.
  
  Conclusion:
  
  Ongoing engagement of laboratory personnel to oversee processes at all levels of the survey is critical for successful national surveys. High quality PHIA laboratory data ensured reliable results and demonstrated impact of HIV programs in 13 countries.
  
  
• Subjects:
  Developing Countries Epidemiological Monitoring Health Surveys HIV-1 HIV Infections Humans Laboratory Personnel Laboratory Proficiency Testing Quality Control
• Keywords:
  HIV Laboratory Testing PHIA Quality Survey Training
• Source:
  J Acquir Immune Defic Syndr. 87(Suppl 1):S17-S27
• Pubmed ID:
  34166309
• Pubmed Central ID:
  PMC10966620
• Document Type:
  Journal Article
• Funding:
  U2G GH001226/GH/CGH CDC HHSUnited States/ ; U2G GH001271/GH/CGH CDC HHSUnited States/ ; PEPFAR/PEPFARUnited States/
• Volume:
  87
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:f245005cea1685baafc63cae1e3dab70b0ce04fa4469b5848ed42eb9d57dbcf1
• Download URL:
  https://stacks.cdc.gov/view/cdc/153578/cdc_153578_DS1.pdf
• File Type:
  [PDF - 1.32 MB ]