Technical Specifications Series 7 (TSS–7) for Submission to WHO Prequalification – Diagnostic Assessment: Rapid Diagnostic Tests to Detect Hepatitis C Antibody or Antigen. Geneva: World Health Organization; 2019
(2019; 33 pages)

Abstract

The purpose of this document is to provide technical guidance to in vitro diagnostic (IVD) medical device manufacturers that intend to seek WHO prequalification of rapid diagnostic tests (RDTs) for the:

  • detection of antibodies to Hepatitis C virus (HCV) in whole blood, serum, plasma or oral fluid;
  • detection of antigens to HCV in whole blood, serum, plasma or oral fluid.
  • Assays which detect both antibodies in combination with antigens to HCV are not within the scope of this specifications.

Minimum performance requirements for WHO prequalification are summarized in this document and apply equally to RDTs intended solely for HCV detection, and to those tests where HCV detection comprises one component of a multidetection assay (e.g. a HIV/HCV RDT). The current version of this document does not address the requirements for accompanying quality control material. However, if quality control material is provided with the assay, it should demonstrate that the IVD is functional and performs as claimed (ISO 15198).

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.

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.

Where possible, WHO analytical and clinical performance study requirements 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.

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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