InBios announced today that it received 510K Clearance from the FDA for its Chagas Detect Plus Rapid Test Kit (CDP). The product is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood). CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. Reactive test results will be presumptive evidence of infection with T. cruzi.
This simple two-step rapid diagnostic test is offered in a convenient cassette format, and results can be obtained in 20 minutes. In several clinical studies, the CDP demonstrated greater than 95% sensitivity and specificity in both endemic and non-endemic populations. The kit can be stored at room temperature for up to 24 months.
This is the first point-of-care diagnostic test available in the United States for Chagas. Primary care settings now have a highly sensitive and specific reliable test to detect Chagas in minutes. The kit is also CE marked and available internationally.
Estela Raychaudhuri, President of InBios, said, “We are excited to bring this long awaited, fast and affordable point of care Chagas test to the US market. The CDP utilizes InBios’ proprietary multi-epitope recombinant antigen target in combination with a proprietary lateral flow system. The assay was developed in part through funding from the National Institutes of Health and in collaboration with the Infectious Disease Research Institute (Seattle, WA).”