In vitro diagnostics and laboratory technology

Hepatitis B test kit evaluations

Infection with the Hepatitis B virus is characterised by the appearance of certain viral markers including Hepatitis B surface Antigen (HBsAg) in the blood. It is recommended that all blood donations are tested for this marker to avoid transmission to recipients.

Report 2

Laboratory diagnosis of Hepatitis B infection centres on the detection of HBsAg, as the most important means for ensuring blood safety. Positive test reactions are then confirmed by retesting with a neutralization assay.

Composition of the panel

HBsAg test kit evaluations are carried out by the WHO Collaborating Centre-Health Protection Agency, London, UK on the WHO HBsAg reference panel of stored serum/plasma specimens of geographically diverse origin, seroconversion panels and low titer panels.

Past evaluations

A total of 18 assays to detect HBsAg have been evaluated by WHO, 13 of these were tests of simple/rapid format. Many of these tests are being produced in countries with transient economies and have not been licensed by well known regulatory authorities.

Guidance document

Related documents

Related links

External web sites

Emergency Use Assessment And Listing (EUAL) Procedure


Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
1211, Geneva 27