Comparing the Performance of HIV Rapid Diagnostic Tests used in Zambia - A Systematic Clinical Data Review

Abstract

ABSTRACTObjectiveTo investigate the performance of the HIV RDTs used in Zambia.Method2,564 participants aged between 15 and 95 years from two sites in Lusaka province years were tested on OraQuick ADVANCE, Abbot Determine™, and then confirmed on Uni-Gold™ Recombigen®. The data from the participants were analyzed using SPSS version 25.0.ResultsThe 3 RDTs when compared to the 4th generation Abbot Architect results had the following results: OraQuick ADVANCE®, Alere Determine and Uni-Gold Ultra, at 95% CI had Sensitivities of: 91.8%, 93.3% and 92.5% respectively. The specificities of OraQuick ADVANCE® and Uni-Gold were the same (100.0%; 95% CI: 98.8 -100.0) but slightly different from Alere Determine (99.8%). Positive predictive values at 95% CI were 100% for OraQuick ADVANCE® and Uni-Gold and 98.4% for Alere Determine. Negative predictive values (at 95% CIs) were 99.1, 99.2 and 99.1 for OraQuick ADVANCE®, Alere Determine, and Uni-Gold Ultra respectively. The results showed that these RDTs could only detect 12 out of every 13 HIV positive results.ConclusionThird generation RDTs are not effective in detecting acute positive cases. Fourth generation Rapid Tests are required to capture the positive cases being missed out.