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Disease/health condition -
Hepatitis C virus (HCV) infection
Combined antibodies to HCV and HCV core antigen
Assay format
Immunoassay
Information History
First added in 2018
Changed in 2020
Purpose type
Screening, Aid to diagnosis
Purpose
To screen for HCV infection, and to aid in the diagnosis of viraemic HCV infection in infants > 18 months of age, children, adolescents and adults. To screen blood donations for HCV.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
GMDN
48381
Hepatitis C virus antibody/antigen 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 Hepatitis C virus antigens and antibodies to Hepatitis C virus antigens 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
W0105020308
HEPATITIS C VIRUS (HCV) ANTIGEN/ANTIBODY COMBO TEST
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. (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 13 IVD tests for HCV. 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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