Call for public consultation - Technical specifications for selection of essential in vitro diagnostics for antibodies to hepatitis C virus, combined antibodies to HCV and HCV core antigen, HCV core antigen and qualitative or quantitative HCV nucleic acid

WHO welcomes organizations and individuals to review and provide comments/suggestions on this document. The reviewers should use the comment column in each technical specifications listed in the Excel file.

Please provide your feedback no later than 10 May 2023, 12PM CEST, by email to EDLsecretariat@who.int. It is important that you provide us with your name and affiliation when sending your comments. Please note that comments will only be considered if they are received before the deadline mentioned above.

Technical specifications for IVDs suggest a set of pre-defined criteria and baseline requirements to ensure good quality, safety, performance and efficacy. They are decisive companions to the WHO Model list of Essential In Vitro Diagnostics (EDL) that will allow Member States, donor agencies and NGOs to select specific products within each test category of the EDL and will guide procurement decisions. 

The present publication defines the basic generic technical characteristics of IVDs for use in community settings and health facilities without laboratories (1 test):

1. Antibodies to hepatitis C virus (anti-HCV) Rapid Diagnostic Test (RDT)

for use in clinical laboratories (8 tests):

1. Antibodies to hepatitis C virus (anti-HCV) Rapid Diagnostic Test (RDT)
2. Antibodies to hepatitis C virus (anti-HCV) Immunoassay with manual method
3. Antibodies to hepatitis C virus (anti-HCV) Immunoassay with automated method
4. Combined antibodies to HCV (anti-HCV) and HCV core antigen (HCVcAg) Immunoassay with manual method
5. HCV core antigen (HCVcAg) Immunoassay with automated method
6. Qualitative or quantitative HCV nucleic acid test with manual method
7. Qualitative or quantitative HCV nucleic acid test with semi-automated method
8. Qualitative or quantitative HCV nucleic acid test with fully automated method

for blood screening laboratories (4 tests):

1. Antibodies to hepatitis C virus (anti-HCV) Rapid Diagnostic Test (RDT)
2. Antibodies to hepatitis C virus (anti-HCV) Immunoassay with manual method
3. Antibodies to hepatitis C virus (anti-HCV) Immunoassay with automated method
4. Combined antibodies to HCV (anti-HCV) and HCV core antigen (HCV cAg) Immunoassay with manual method