In vitro diagnostic medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid
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World Health Organization
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v, 25 p.
This document provides technical specifications for manufacturers seeking WHO prequalification of in vitro diagnostic (IVD) medical devices intended for the qualitative detection of HIV-1 and HIV-2 nucleic acid using nucleic acid amplification technologies. It outlines the evidence requirements necessary to demonstrate that such assays perform reliably and consistently for their intended use across different specimen types, testing environments and user populations. The guidance applies to assays that detect HIV-1 and HIV-2 with or without differentiation between the two viruses and forms part of the WHO Technical Specifications Series for diagnostic assessment. The publication describes the analytical, clinical and usability studies required to support WHO prequalification submissions. It details expectations for specimen validation, analytical sensitivity and specificity, subtype detection, assay precision, stability, interference and cross-reactivity assessments, validation of assay procedures, and performance across diverse operational settings. Additional requirements are provided for clinical performance studies and for near point-of-care testing conducted by health-care professionals. The document also emphasizes the importance of clearly defined intended use, appropriate reference methods, robust study design and comprehensive performance data to support regulatory evaluation and ensure the quality, safety and effectiveness of HIV nucleic acid detection assays.
This document provides technical specifications for manufacturers seeking WHO prequalification of in vitro diagnostic (IVD) medical devices intended for the qualitative detection of HIV-1 and HIV-2 nucleic acid using nucleic acid amplification technologies. It outlines the evidence requirements necessary to demonstrate that such assays perform reliably and consistently for their intended use across different specimen types, testing environments and user populations. The guidance applies to assays that detect HIV-1 and HIV-2 with or without differentiation between the two viruses and forms part of the WHO Technical Specifications Series for diagnostic assessment. The publication describes the analytical, clinical and usability studies required to support WHO prequalification submissions. It details expectations for specimen validation, analytical sensitivity and specificity, subtype detection, assay precision, stability, interference and cross-reactivity assessments, validation of assay procedures, and performance across diverse operational settings. Additional requirements are provided for clinical performance studies and for near point-of-care testing conducted by health-care professionals. The document also emphasizes the importance of clearly defined intended use, appropriate reference methods, robust study design and comprehensive performance data to support regulatory evaluation and ensure the quality, safety and effectiveness of HIV nucleic acid detection assays.