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Disease/health condition - Hepatitis B virus (HBV) infection
IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc)
Setting:
2. Laboratory
Tiered Testing Service:
Regional or provincial hospital with laboratory
Assay format
Immunoassay
Information History
First added in 2018
Changed in 2020
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of acute HBV infection in the context of outbreak investigation.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN

48297

Hepatitis B virus core immunoglobulin M (IgM) 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 immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen 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 2005-2024
EMDN

W0105020210

HEPATITIS B CORE ANTIBODY IGM

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
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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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