Protocol for the performance evaluation of rapid diagnostic tests for the detection of Vibrio cholerae O1 or O1/O139 for WHO prequalification assessment, PQDx_305 version 2

World Health Organization

2024年2月 · World Health Organization

关于此电子书

This protocol, published by the World Health Organization in 2023, provides a comprehensive guide for the performance evaluation of rapid diagnostic tests for detecting Vibrio cholerae O1 or O19. Aimed at Performance Evaluation Laboratories and manufacturers of in vitro diagnostics, the document outlines procedures for assessing the accuracy, sensitivity, specificity, and operational ease of use of these tests in laboratory settings. It emphasizes compliance with WHO requirements and is designed to ensure suitability for use in resource-limited environments. The protocol includes detailed instructions on specimen collection, data analysis, quality control measures, and ethical considerations, making it an essential resource for those involved in the evaluation of diagnostic tools for cholera detection.