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
- 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
- New alternative performance evaluation mechanism
- Sample Product Dossier for a Qualitative Test for HIV-1 and HIV-2 ((for public comment to be submitted to email@example.com no later than 31 July 2016)
- New Guidance for Manufacturers TGS 3 Principles of Performance Studies (for public comment to be submitted to firstname.lastname@example.org no later than 31 July 2016)
G6PD Prequalification: Public Announcement to Stakeholders
Newsletter Issue 13, Q1 2016
Guidance for post-market surveillance
Prioritization criteria expanded to HPV