Chagas Detect™ Plus Rapid Test
FDA Cleared for In Vitro Diagnostic Use in the United States
The Chagas DetectTM Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human lgG 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. 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.
Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.