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.
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.
To date, 14 assays for the detection of antibody to HCV have been evaluated, including 5 ELISA tests and 9 simple/rapid tests.
External web sites
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Alternative Performance Evaluation Mechanism
- WHO Prequalification Fees
- Complaints and Product Alerts
- Streamlining of the Prequalification of Diagnostics
- WHO Prequalification of Male Circumcision Devices
- Procurement of in vitro diagnostics
- HIV incidence assay working group
- Information resources
Global public consultation on WHO prequalification of similar biotherapeutic products
News releases: 2017
- WHO prequalified first HIV Self-Test
- First WHO prequalified hepatitis C rapid test opens the door to expanded treatment
- Two cutting-edge technologies for HIV detection in infants receive WHO prequalification
New! Change of WHO recommendations on malaria RDT procurement
G6PD Prequalification: Public Announcement to Stakeholders
Guidance for post-market surveillance