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.
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.
Related documents
Related links
External web sites
Publications
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Circonstances et modalités d’utilisation des tests d’infection récente pour estimer l’incidence de l’infection à HIV au niveau d’une population.
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When and how to use assays for recent infection to estimate HIV incidence at a population level
pdf, 2.24Mb -
HIV Rapid Assays: Operational Characteristics Report 16
pdf, 2.28Mb - View all documents
Key events
- WHO Prequalification of Medicines, Diagnostics and Vaccines: 6th Consultative Meeting with Stakeholders, 4-5 April 2011
- WHO Technical Working Group Meeting on CD 4 Technologies,17 -19 November 2009
- WHO Technical Working Group Meeting on Prequalification of HIV Virological Technologies, 21-23 September 2009
- View all events
