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.

Related links

Highlights

  • Newsletter Issue 10, Q2 2015
    pdf, 490kb

    This issue includes the new streamlined approach, abbreviated procedure, intersted in Ebola? Find our what the WHO PQ Dx team has been doing the field of Ebola Virus Disease (EVD) IVDs.

Events

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    The 2015 Joint WHO-UNICEF-UNFPA meeting with pharmaceutical and diagnostics manufacturers and suppliers will be held in Copenhagen during the week of 23-27 November
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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