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Disease/health condition -
Hepatitis B virus (HBV) infection
Antibodies to hepatitis B surface antigen (anti-HBs)
Assay format
Immunoassay
Information History
First added in 2018
Changed in 2020
Purpose type
Monitoring
Purpose
To determine immune status due to HBV immunization.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
48315
Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus surface in a clinical specimen, using an enzyme immunoassay (EIA) method.
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 2005-2024EMDN
W0105020203
HEPATITIS B SURFACE ANTIBODY (TOTAL)
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/emdnWHO supporting publications
World Health Organization. (2017). WHO guidelines on hepatitis B and C testing. World Health Organization. https://iris.who.int/handle/10665/254621 ; World Health Organization. (2024). Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection. World Health Organization. https://iris.who.int/handle/10665/376353
Technical specifications
This tool presents technical specifications for 16 IVD tests for HBV. To review the one(s) of your interest, download the file and go to the “Test menu” tab to make your selection. You will find more details in the “Content” tab of this file.
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.
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The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
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