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. 2021 Aug 1;87(Suppl 1):S17-S27.
doi: 10.1097/QAI.0000000000002702.

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

Hetal K Patel  1 , Yen T Duong  2 , Sehin Birhanu  1 , Trudy Dobbs  1 , Kathryn Lupoli  1 , Carole Moore  1 , Mervi Detorio  1 , Katrina Sleeman  1 , Julius Manjengwa  2 , Floris Wray-Gordon  1 , Daniel Yavo  1 , Keisha Jackson  1 , Robert A Domaoal  1 , Ernest L Yufenyuy  1 , Shanmugam Vedapuri  1 , Clement B Ndongmo  1 , Francis M Ogollah  2 , Tafadzwa Dzinamarira  2 , Paul Rubinstein  2 , Karampreet K Sachathep  2 , Melissa Metz  2 , Herbert Longwe  2 , Suzue Saito  2 , Kristin Brown  1 , Andrew C Voetsch  1 , Bharat S Parekh  1
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A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project

Hetal K Patel et al. J Acquir Immune Defic Syndr. .

Abstract

Background: Conducting HIV surveys in resource-limited settings is challenging because of logistics, limited availability of trained personnel, and complexity of testing. We described the procedures and systems deemed critical to ensure high-quality laboratory data in the population-based HIV impact assessments and large-scale household 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 household, satellite laboratories, and central laboratories, accompanied with trainings, optimized process for blood specimen 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 a final quality check for quality of laboratory results.

Results: Overall, we conducted a hands-on training for 3355 survey staff across 13 surveys, with 160-387 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 CD4 instruments, and monitored user errors. Aggregate data review for plausibility further confirmed the high quality of testing.

Conclusions: Ongoing engagement of laboratory personnel to oversee processes at all levels of the surveys is critical for successful national surveys. High-quality population-based HIV impact assessments laboratory data ensured reliable results and demonstrated the impact of HIV programs in 13 countries.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Engagement of laboratory personnel at all levels of surveys from planning to aggregate data review is essential for high quality of laboratory data.
Figure 2.
Figure 2.
A schematic showing tiered structure of the survey for specimen collection, testing, handling and transportation in households, satellite/mobile laboratories, and central laboratory within PHIA surveys.
Figure 3.
Figure 3.
Organized fully stocked household tool box that were provided to each field tester. Items contained personal protective equipment (PPE), blood collection supplies, household testing kits and safety and waste management supplies.
Figure 4.
Figure 4.
Schematic of various biomarker trainings for the survey conducted for testers at different levels.
See this image and copyright information in PMC

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