cross-sectional·infectious disease, public health, epidemiology, clinical trial, research methods·PMC10021713
Evaluation of the Nigeria national HIV rapid testing algorithm
PLOS Global Public Health · 35 authors, 9 centres
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A cross-sectional evaluation using retrospective program data from 492,880 clients and prospective specimens from 2,895 clients found that Nigeria's national serial HIV rapid testing algorithm (Determine, Unigold, Stat-Pak) performed well overall but achieved lower sensitivity and PPV in the field than in the controlled laboratory environment.
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This study evaluated Nigeria's national serial HIV rapid testing algorithm (Determine, Unigold, and Stat-Pak) in two phases. The retrospective phase reviewed routine HTS program data (n = 492,880) from six geopolitical zones (January 2017 to December 2019), finding an overall HIV positivity of 5.7% and a discordant rate of 1.1% between Tests 1 and 2. The prospective phase collected 2,895 samples from field HTS sites, retested them at the National Reference Laboratory using the same algorithm and supplementary assays (Geenius and multiplex). Field testing showed sensitivity of 96.6% and PPV of 97.0% compared with the multiplex assay, while NRL retesting achieved sensitivity of 99.2% and PPV of 99.0%, meeting WHO-recommended thresholds. All discordant rates were below the WHO-recommended 5% threshold. Limitations include the cross-sectional design, purposive site selection, and reliance on routine program data for the retrospective component. The findings support a need for continuous quality improvement and refresher training for field testers.