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Disease/health condition -
Hepatitis C virus (HCV) infection
HCV nucleic acid amplification test
Assay format
NAAT
Information History
First added in 2018
Changed in 2022
Purpose type
Diagnosis, Monitoring
Purpose
To diagnose viraemic HCV and as a test of cure.
Specimen types
Capillary whole blood, Venous whole blood, Serum, Plasma, Dried blood spots (DBS)
WHO prequalified or recommended products
GMDN
48374
Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).
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
W0105020307
HEPATITIS C VIRUS - NA REAGENTS
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
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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