Laboratory Performance Evaluation of Wantai HIV 1/2 Rapid Test Kit

Abstract

Background: Detection of specific antibodies in the blood/body fluids is the primary testing method for HIV infection. A rapid test is one of the assays used in detecting HIV-specific antibodies. This study was conducted to evaluate the laboratory performance of the Wantai HIV 1/2 Rapid Test Kit. Study Design: Cross-sectional laboratory-based performance characteristics study. Place of Study: The study was conducted across all the six geopolitical zones in Nigeria (North Central, North East, North West, South West, South East, and South-South). Methodology: This study was a cross-sectional laboratory-based performance evaluation with specimens obtained from Nigeria’s six geopolitical zones, characterised in the reference laboratory, and used to evaluate the Wantai test-kit. Ten millilitres of whole blood were collected from all the study sites in EDTA vacutainer tubes through venous puncture from participants, coded, centrifuged, and plasma harvested into cryovials in three aliquots of 2mls each. All specimens were retested using a combination of determine and Unigold rapid test kits. Samples that tested positive or negative concordantly with these kits were used to evaluate the Wantai HIV test kit. The data were entered in Excel and analysed with IBM-SPSS-version 25. Result: Of the 1353 samples, 697 were HIV positive, and 656 were negative. Wantai RTK accurately detected 694(99.6%) positive and 649(98.9%) negative samples. Its sensitivity was 99.57% [95% CI:98.75%-99.91%], and the specificity was 98.93%[95%CI:97.81%-99.57%], with 99.26%[95%CI:98.64%-99.64%] accuracy. Collecting the correct plasma volume was at a 90.0% rate, reading the test result within the time limit, line visibility, interpreting the result, learning the procedure, design of the kit and waste generated were all at the rate of 100.0%. Conclusion: With a sensitivity of 99.6% and a specificity of 98.9%, the Wantai HIV rapid test is suitable for inclusion as a first-line (screening) test in Nigeria’s HIV testing algorithm.