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
- EBOLA IVDs
- 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
Invitation to manufacturers of in vitro diagnostics for Zika virus to submit an application for emergency use assessment and listing by WHO
ZIKA VIRUS: Emergency Use Assessment and Listing Procedure (EUAL) announcement
- Sample product dossier for an IVD intended for HIV self-testing (for public comments to be submitted to email@example.com no later than 29 February 2016)
- New Guidance for Manufacturers (TGS 1 & TGS 2) (for public comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
Newsletter Issue 12, Q4 2015
Guidance for post-market surveillance
Prioritization criteria expanded to HPV