Japanese Journal of Infectious Diseases
Online ISSN : 1884-2836
Print ISSN : 1344-6304
ISSN-L : 1344-6304
Original Articles
Diagnostic Accuracy of Human Immunodeficiency Virus In Vitro Assays Evaluated by the World Health Organization Prequalification Evaluation Laboratories: Systematic Review and Meta-Analysis
Santanu BanerjeeMihir BhattaSrijita NandiShanta DuttaMalay Kumar Saha
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2022 Volume 75 Issue 5 Pages 445-453

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Abstract

To maintain the performance quality, human immunodeficiency virus (HIV) in vitro diagnostic (IVD) kits are required to be evaluated by unbiased health regulatory organizations following predefined guidelines. The World Health Organization (WHO) prequalification is one such program for the evaluation of IVD assays. In the present systematic review and meta-analysis, we analyzed and compared the 17 WHO prequalified public reports of HIV IVDs to yield summarized information for performance parameters. Pooled sensitivity, pooled specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio were used as overall performance evaluation parameters. High (≥98%) and comparable levels of sensitivity and specificity were observed for most of the assays. In addition, the overall diagnostic efficiency was observed to attain high precision, as evident by the value of the area under the curve (AUC) for the hierarchical summary receiver operating characteristic curve (AUC ≥ 0.98).

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