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.

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Request for Proposals

22 MARCH 2017

The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibility for on-going system maintenance and effectiveness of operations within the Prequalification Team.

The services required by the World Health Organization (WHO) are more fully described in the below attached Terms of Reference and Request for Proposals.

Proposals should be submitted to WHO in writing no later than 5 April 2017 at 17:00 hours Geneva time ("the closing date"), by email at the following address:


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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