Call for public consultation - Technical specifications for hepatitis B virus (HBV) surface antigen, quantitative HBV nucleic acid, hepatitis B e antigen, IgM-specific antibodies to hepatitis B core antigen, and antibodies to hepatitis B surface antigen

Closed call

Deadline 10 May 2023, 12PM CEST

WHO is pleased to present draft technical specifications for selection of essential in vitro diagnostics (IVDs) for hepatitis B virus surface antigen (HBsAg), quantitative HBV nucleic acid, hepatitis B e antigen (HBeAg), IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc) and antibodies to hepatitis B surface antigen (anti-HBs) listed in the 3rd WHO Model List of Essential In Vitro Diagnostics (EDL).

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. Hepatitis B virus surface antigen (HBsAg) Rapid Diagnostic Test (RDT)

for use in clinical laboratories (12 tests):

1. Hepatitis B virus surface antigen (HBsAg) Rapid Diagnostic Test (RDT)
2. Hepatitis B virus surface antigen (HBsAg) Immunoassay with manual method
3. Hepatitis B virus surface antigen (HBsAg) Immunoassay with automated method
4. Quantitative HBV nucleic acid test (NAT) with manual method
5. Quantitative HBV nucleic acid test (NAT) with semi-automated method
6. Quantitative HBV nucleic acid test (NAT) with fully automated method
7. Hepatitis B e antigen (HBeAg) Immunoassay with manual method
8. Hepatitis B e antigen (HBeAg) Immunoassay with automated method
9. IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc) Immunoassay with manual method
10. IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc) Immunoassay with automated method
11. Antibodies to hepatitis B surface antigen (anti-HBs) Immunoassay with manual method
12. Antibodies to hepatitis B surface antigen (anti-HBs) Immunoassay with automated method

for blood screening laboratories (3 tests):

1. Hepatitis B virus surface antigen (HBsAg) Rapid Diagnostic Test (RDT)
2. Hepatitis B virus surface antigen (HBsAg) Immunoassay with manual method
3. Hepatitis B virus surface antigen (HBsAg) Immunoassay with automated method