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

Highlights

  • Newsletter Issue 10, Q2 2015
    pdf, 490kb

    This issue includes the new streamlined approach, abbreviated procedure, interested in Ebola? Find what the WHO PQ Dx team has been doing in the field of Ebola Virus Disease (EVD) IVDs.

Events

  • HOLD THE DATE!
    The 2015 Joint WHO-UNICEF-UNFPA meeting with pharmaceutical and diagnostics manufacturers and suppliers will be held in Copenhagen during the week of 23-27 November
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Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
(HIS/EMP/RHT/PQT)
World Health Organization
20 Avenue Appia
1211, Geneva 27
Switzerland
diagnostics@who.int