Technical Specifications Series 3 (TSS–3) for Submission to WHO Prequalification – Diagnostic Assessment: Malaria Rapid Diagnostic Tests
(2017; 23 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 IVDs for the detection, in blood, of antigens produced by Plasmodium (malaria) species. For the purposes of WHO Prequalification, this document applies to only to rapid diagnostic tests (RDTs) intended to diagnose malaria infection.

A documented justification and rationale shall be provided by the manufacturer when the WHO Prequalification submission does not comply with the required technical specifications outlined in this document.

Minimum performance requirements for WHO Prequalification are summarized in this document and, where possible, are aligned with published guidance, standards and/or regulatory documents. Although references to source documents are provided, in some cases WHO Prequalification has additional requirements. External quality controls are outside the scope of this document

For WHO Prequalification purposes, manufacturers shall provide evidence in support of the clinical performance of an IVD to demonstrate that reasonable steps have been taken to ensure that a properly manufactured IVD, being correctly operated in the hands of the intended user, will detect the target analyte and fulfil its indications for use.

WHO Prequalification requirements summarized in this document do not extend to the demonstration of clinical utility, i.e. the effectiveness and/or benefits of an IVD, relative to and/or in combination with other measures, as a tool to inform clinical intervention in a given population or healthcare setting. To demonstrate clinical utility, a separate set of studies is required. Clinical utility studies usually inform programmatic strategy and are thus the responsibility of programme managers, ministries of health and other related bodies in individual WHO Member States. Such studies do not fall under the scope of WHO Prequalification.

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