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Disease/health condition - Hepatitis B virus (HBV) infection
Hepatitis B surface antigen (HBsAg)
Setting:
1. Non-laboratory
Tiered Testing Service:
Primary health care center without laboratory District hospital with laboratory Blood establishment laboratory
Assay format
Lateral flow RDT
Information History
First added in 2018
Changed in 2022
Purpose type
Screening, Aid to diagnosis
Purpose
To screen for HBV infection, and to aid in the diagnosis of chronic and acute HBV infection in infants > 12 months of age, children, adolescents and adults.* . To screen blood donations for HBV in laboratories with small throughput, in remote areas or emergency situations.
* For acute infection, IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc) are needed in addition to HBsAg
Specimen types
Capillary whole blood, Venous whole blood, Serum, Plasma
WHO prequalified or recommended products
GMDN

48322

Hepatitis B virus surface antigen IVD, kit, rapid ICT, 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 an immunochromatographic test (ICT) method* . This is a rapid test 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
* lateral flow test
EMDN

W0105090201

HBSAG - RT & POC

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. (‎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 ; World Health Organization. (‎2009)‎. Screening donated blood for transfusion-transmissible infections : recommendations. World Health Organization. https://iris.who.int/handle/10665/44202
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.
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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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