In vitro diagnostics and laboratory technology

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.

Past evaluations

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.

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EMERGENCY USE ASSESSMENT AND LISTING (EUAL) PROCEDURE


Request for Proposals

22 MARCH 2017

The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibility for on-going system maintenance and effectiveness of operations within the Prequalification Team.

The services required by the World Health Organization (WHO) are more fully described in the below attached Terms of Reference and Request for Proposals.

Proposals should be submitted to WHO in writing no later than 5 April 2017 at 17:00 hours Geneva time ("the closing date"), by email at the following address: mubangizid@who.int

ESSENTIAL MEDICINES AND HEALTH PRODUCTS


Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
(HIS/EMP/RHT/PQT)
World Health Organization
20 Avenue Appia
1211, Geneva 27
Switzerland
diagnostics@who.int