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Abbott's Chagas disease screening test approved in US

This article was originally published in Clinica

Executive Summary

The US FDA has approved Abbott's blood screening test for Trypansoma cruzi via a biologic licence application (BLA). The firm claims the Abbott Prism Chagas is the first fully automated blood test for the parasite, which causes Chagas disease. Symptoms of the disorder, which is mainly found in Central and South America, include heart disease and gastrointestinal malformations, and it can be fatal if left untreated. Around 8-11 million people are infected worldwide, according to the US Centers for Disease Control and Prevention. Blood centres in the US started screening for antibodies to T cruzi in 2007 to minimise transmission of the disease. Abbott's test, an in vitro chemiluminescent immunoassay, is not intended for diagnosing Chagas infection.

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