In vitro diagnostics and laboratory technology

Hepatitis C test kit evaluations

Laboratory diagnosis of infection with the Hepatitis C virus is characterised by the detection of antibodies to HCV. Positive test results are usually confirmed with line immunoassays. It is recommended that all blood donations are tested for HCV.

hepatitis c test kit

The number of available HCV antibody tests, including simple/rapid tests has increased in recent years. Many of these tests are produced in countries with transient economies.

Composition of the panel

Test kits are evaluated against the WHO HCV reference panel of characterised serum/plasma specimens, collected from geographically diverse regions, seroconversion panels, low titre and world wide panels. The practical work is carried out by the WHO Collaborating Centre, Health Protection Agency, London, UK.

Field evaluations have been conducted for some of the assays. Different HCV sero- and genotypes have been identified and tests kits continue to improve to allow for detection of all HCV types.

Past evaluations

To date, 14 assays for the detection of antibody to HCV have been evaluated, including 5 ELISA tests and 9 simple/rapid tests.

Related documents

Related links

External web sites

Emergency Use Assessment And Listing (EUAL) Procedure


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Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
1211, Geneva 27