Technical Specifications Series 5 (TSS–5) for Submission to WHO Prequalification – Diagnostic Assessment: Rapid Diagnostic Tests (RDTs) Used for Surveillance and Detection of an Outbreak of Cholera
(2018; 25 pages)

Abstract

The purpose of this document is to provide technical guidance to in vitro diagnostic medical device (IVD) manufacturers that intend to seek WHO Prequalification of rapid diagnostic tests (RDTs) for the detection of toxigenic Vibrio cholerae. This document is relevant to RDTs that can be used near to the patient, in settings outside of a laboratory environment, and that detect toxigenic V. cholerae strains that are associated with epidemic spread. It must be able to be used by health care workers and trained community workers. A V. cholerae IVD submitted for WHO Prequalification is expected to detect V. cholerae O1 or O1/O139 in combination, (being the strains consistently considered toxigenic), or are capable of detecting O1/O139 toxin prior to strain confirmation. IVDs will only be prequalified based on the evidence that supports their use for the detection of outbreaks or surveillance for this disease.

The requirements outlined in this document do not include those that demonstrate that the IVD can be used for other purposes, such as the diagnosis of an individual, or for patient management. Nor do they include requirements for use of the product for environmental testing. If claimed, these additional intended uses must be clearly stated and supported by relevant evidence.

Likewise, field-deployable rapid tests for cholera that are quantitative or are based on other technologies, such as nucleic acid amplification tests, will have different and/or additional requirements for WHO Prequalification and these are not included in this TSS.

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