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.
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.
External web sites
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Complaints and Product Alerts
- Streamlining of the Prequalification of Diagnostics
- WHO Prequalification of Male Circumcision Devices
- Procurement of in vitro diagnostics
- HIV incidence assay working group
- Information resources
- Two cutting-edge technologies for HIV detection in infants receive WHO prequalification
- New! Alternative performance evaluation mechanism
- New! Sample product dossier for public comment
- New! Guidance for manufacturers for public comment
New! Change of WHO recommendations on malaria RDT procurement
G6PD Prequalification: Public Announcement to Stakeholders
Guidance for post-market surveillance
Prioritization criteria expanded to HPV