Chagas Detect™ Plus Rapid Test
FDA Cleared for In Vitro Diagnostic Use
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.
- FDA 510(k) Cleared for in vitro diagnostic use in the United States
- Sensitivity and Specificity: > 95%
- For use with venous and capillary whole blood or serum
- Fast Results: 20 minutes
- Field Friendly: Refrigeration and lab equipment not required
- CE Marked
|Catalog No.||Format||Quantity/Kit||Time to Result||Sample Type||Storage||Shelf Life|
|CP050||ICT (cassette)||50 Tests||20 minutes||Whole Blood or Serum||Room Temperature|
Whitman, J.D., Bulman, C.A., Gunderson, E.L., Irish, A.M., Townsend, R.L., Stramer, S.L., Sakanari, J.A., Bern, C. (2019). Chagas Disease Serological Test Performance in U.S. Blood Donor Specimens. Journal of Clinical Microbiology. https://doi.org/10.1128/JCM.01217-19
Egüez KE, Alonso-Padilla J, Terán C, Chipana Z, García W, Torrico F, et al. (2017) Rapid diagnostic tests duo as alternative to conventional serological assays for conclusive Chagas disease diagnosis. PLoS Negl Trop Dis 11(4): e0005501. doi:10.1371/journal.pntd.0005501
Shah, V., Ferrufino, L., Gilman, R. H., Ramirez, M., Saenza, E., Malaga, E., Bern, C. (2014). Field Evaluation of the InBios Chagas Detect Plus Rapid Test in Serum and Whole-Blood Specimens in Bolivia. Clinical and Vaccine Immunology : CVI, 21(12), 1645–1649. http://doi.org/10.1128/CVI.00609-14