Technical Specifications Series 4 (TSS–4) for Submission to WHO Prequalification – Diagnostic Assessment: In Vitro Diagnostic Medical Devices (IVDs) Used for the Detection of High-risk Human Papillomavirus (HPV) Genotypes in Cervical Cancer Screening
(2018; 29 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 tests for the detection of human papillomavirus (HPV). This document is relevant to IVDs that detect HPV genotypes that are associated with cervical cancer. Although this does not exclude those IVDs that may claim to detect other HPV associated cancers (e.g. anal cancer), IVDs will only be prequalified on the basis of evidence that pertains specifically to detection of HPV types associated with cervical cancer. 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. A full list of the individual studies is provided in Section D. • Part 1 lists the analytical studies that are required to assess the ability of the IVD to measure the relevant analyte(s). • Part 2 lists the clinical studies that are required to support the clinical performance of an IVD, and 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. Clinical utility studies, 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 each population or healthcare setting, do not fall under the scope of WHO Prequalification and are not included in this document. Clinical utility studies usually inform programmatic strategy and are thus the responsibility of programme managers, ministries of health and other relevant bodies in individual WHO Member States.
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