External quality assessment schemes for HIV, HBsAg and HCV serology
Four WHO regional External Quality Assessment Schemes (EQAS) for HIV, HBsAg and HCV serology are operational in:
- Africa (anglophone)
- Africa (francophone)
- South East Asia
- Western Pacific
EQAS are planned to commence in the Americas soon.
A total of approximately 130 reference laboratories and blood transfusion services receive proficiency panels at regular intervals to monitor their performance.
In addition, information is collected regarding the type and brands of test kits used and the testing strategies adopted.
Summary reports on each distribution are produced and impartial analysis conducted. Assistance is provided to laboratories with substandard performance.
Countries are encouraged to establish their own national EQAS using WHO guidelines for assistance.
Organising EQAS Guidelines for HIV Serological Testing
HBV panel March 2008 EQAS report
HBV panel October 2008 EQAS report
HCV panel March 2008 EQAS report
HCV panel October 2008 EQAS report
HIV panel March 2008 EQAS report
HIV panel October 2008 EQAS report
WHO Collaborating Centres 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
- Request for Proposals: Prequalification Team Quality Systems Consultancy
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