Diagnostic Accuracy of Human Immunodeficiency Virus In Vitro Assays Evaluated by the World Health Organization Prequalification Evaluation Laboratories: Systematic Review and Meta-Analysis

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...

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Veröffentlicht in:Japanese Journal of Infectious Diseases 2022/09/30, Vol.75(5), pp.445-453
Hauptverfasser: Banerjee, Santanu, Bhatta, Mihir, Nandi, Srijita, Dutta, Shanta, Saha, Malay Kumar
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Sprache:eng
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Zusammenfassung: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).
ISSN:1344-6304
1884-2836
DOI:10.7883/yoken.JJID.2021.720