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.

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