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.
WHO performance evaluation acceptance criteria for HBsAg in vitro diagnostics in the context of WHO prequalification
External web sites
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Alternative Performance Evaluation Mechanism
- WHO Prequalification Fees
- 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
- Request for Proposals: Prequalification Team Quality Systems Consultancy
Global public consultation on WHO prequalification of similar biotherapeutic products
News releases: 2017
- WHO prequalified first HIV Self-Test
- First WHO prequalified hepatitis C rapid test opens the door to expanded treatment
- Two cutting-edge technologies for HIV detection in infants receive WHO prequalification
New! Change of WHO recommendations on malaria RDT procurement
G6PD Prequalification: Public Announcement to Stakeholders
Guidance for post-market surveillance