Technical Specifications Series 8 (TSS–8) for Submission to WHO Prequalification – Diagnostic Assessment: Immunoassays to detect HCV antibody and/or antigen. Geneva: World Health Organization; 2019
(2019; 28 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:

  • 3rd generation immunoassays (IAs) for the detection of antibodies to hepatitis C virus (HCV);
  • 4th generation IAs intended to detect antibodies and core antigen of HCV; and
  • immunoassays intended to detect HCV core antigen.

It is not intended to cover the requirements for rapid diagnostic tests for HCV which are described in a separate technical specifications series (TSS) document (see TSS-7).

The generally accepted terminology for generations of HCV assays are used in this document: 1st generation using recombinant antigen from the NS4 region of the genome; 2nd generation using synthetic antigens (recombinant or peptide) which, as well as antigen from the NS4 region, incorporate antigens from the HCV core and NS3 regions; 3rd generation using synthetic antigens which might include NS5 along with those specified for 1st and 2nd generation assays, but with improved conformation of the NS3 antigen; 4th generation using synthetic antigens to detect circulating antibodies to viral antigens as described above for 3rd generation assays along with a monoclonal antibody to detect HCV core antigen (p22 Ag) directly.

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. 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 consistently 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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