Download

Disease/health condition - Hepatitis B virus (HBV) infection
Hepatitis B surface antigen (HBsAg)
Setting:
2. Laboratory
Tiered Testing Service:
Blood establishment laboratory
Assay format
Particle agglutination
Information History
First added in 2018
Changed in 2020
Purpose type
Screening
Purpose
To screen blood donations for HBV in laboratories with small throughput, in remote areas or emergency situations.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN

48323

Hepatitis B virus surface antigen IVD, kit, rapid agglutination, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of Hepatitis B virus surface antigen in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W0105090299

HEPATITIS VIRUSES - RT & POC - OTHER

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2009)‎. Screening donated blood for transfusion-transmissible infections : recommendations. World Health Organization. https://iris.who.int/handle/10665/44202
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A