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Disease/health condition - Hepatitis C virus (HCV) infection
Antibodies to hepatitis C virus (anti-HCV)
Setting:
1. Non-laboratory
Tiered Testing Service:
N/A
Assay format
Self-testing
Information History
First added in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of infection with Hepatitis C virus.
Specimen types
Oral fluid
WHO prequalified or recommended products
GMDN

65561

Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, self-testing

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) antibodies to the Hepatitis C virus 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 intended to be used for self-testing by a layperson in the home or similar environment.

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
WHO supporting publications
World Health Organization (2021). Recommendations and guidance on hepatitis C virus self-testing. World Health Organization. https://iris.who.int/handle/10665/342803 ; World Health Organization (2024). Self-testing implementation toolkit for HIV, viral hepatitis and sexually transmitted infections. World Health Organization. https://iris.who.int/handle/10665/380174
Technical specifications
N/A
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