Chagas test kit evaluations
Infection with Trypanosoma cruzi causing Chagas disease is mainly endemic in South and Latin America. Nevertheless, other parts of the world such as the USA and parts of Europe are considering testing all blood donations for T. cruzi due to migration of people from endemic areas and changing travel patterns (e.g.eco tourism).
Composition of the panel
Evaluations of test kits that are primarily produced in Latin America are carried out by the WHO Collaborating Centre, Fundação Pró-Sangue, São Paulo, Brazil on the WHO reference panel of serum/ plasma specimens collected from within the region.
A total of 18 tests have been evaluated, including 11 ELISAs, 7 agglutination tests. Four confirmatory assays, including an immunofluorescence, immunoblot, Western blot and radio-immunoprecipitation (RIPA) tests were used to characterise the panel.
The obtained data are being used for the development guidelines and appropriate testing strategies.
- 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
Change of WHO recommendations on malaria RDT procurement
- 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 firstname.lastname@example.org no later than 31 July 2016)
- New Guidance for Manufacturers TGS 3 Principles of Performance Studies (for public comment to be submitted to email@example.com 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