Diagnostic Accuracy of HIV in-vitro Assays Evaluated by WHO Prequalification Evaluation Laboratories: Systematic Review and Meta-analysis.

Abstract

For maintaining the performance quality, HIV in-vitro diagnostic (IVD) kits are required to be evaluated by unbiased health regulatory organisation following predefined guidelines. WHO prequalification is one such program for evaluation of in-vitro diagnostic assays. In present systematic review and meta-analysis, we analysed and compared seventeen WHO prequalified public reports of HIV IVDs to yield summarised information for performance parameters. Pooled sensitivity, pooled specificity, Positive Likelihood Ratio (PLR), Negative Likelihood Ratio (NLR) and diagnostic odds ratio (DOR) were used as overall performance evaluation parameters. High (≥98%) and comparable level of sensitivity and specificity were observed for most of the assays. The overall diagnostic efficiency was observed to attain high precision as evident by the value of Area under the curve (AUC) for the hierarchical summary receiver operating characteristic (HSROC) curve (AUC≥0.98).