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Chagas Lateral Flow Test Gets FDA Approval


The Chagas Detect™ Plus (CDP) Rapid Test from InBios International is a rapid immunochromatographic strip assay for the qualitative detection of human lgG antibodies to Trypanosoma cruzi in human serum and whole blood matrices (venous and capillary (finger prick) whole blood).

Now FDA 510(k) cleared for in vitro diagnostic use in the USA, CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. With results ready to read within 20 mins, positive results are presumptive evidence of infection with T. cruzi.

The CDP when used in conjunction with other serological and clinical information is useful for the diagnosis of individuals with Chagas disease. Definitive diagnosis of an acute phase infection (including acute congenital infection) must be made by alternative methods, e.g., hemoculture, blood smear. This test is not intended for use on cord blood or for screening blood or plasma donors.


      

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Date Published: 10th January 2017

Source article link: InBios International Inc.


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