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Indication -
Hepatitis C virus (HCV) infection
Qualitative or quantitative HCV nucleic acid test
Assay formats
NAT
Status history
First added in 2018
Changed in 2020
Purpose type
Diagnosis, Monitoring
Purpose
To diagnose viraemic HCV and to monitor response to treatment, and as a test of cure
Specimen types
Capillary whole blood, Venous whole blood, Serum, Plasma, Dried blood spots
WHO prequalified or recommended products
Public reports of WHO prequalified IVDs https://extranet.who.int/pqweb/vitro-diagnostics/prequalification-reports/whopr?field_whopr_category=59
WHO supporting documents
Guidelines on hepatitis B and C testing (February 2017) http://apps.who.int/iris/handle/10665/254621 ; https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
Codes
ICD11 code:
1E51.1
Summary of SAGE IVD recommendation
The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.