Chagas Detect™ Plus Rapid Test

FDA Cleared for In Vitro Diagnostic Use

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

Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.

Resources

  • FDA 510(k) Cleared for in vitro diagnostic use in the United States

  • Relative Sensitivity:  > 95%

  • Relative Specificity:  > 85%

  • For point-of-care use with venous and capillary whole blood or serum

  • Fast Results: 20 minutes

  • Refrigeration and lab equipment not required

  • CE Marked

Catalog No. CP050
Format ICT (cassette)
Quantity/Kit 50 tests
Time to Result 20 minutes
Sample Type Venous or Fingerstick Whole Blood/Serum
Storage Room Temperature (20°C-30°C)

  • This field is for validation purposes and should be left unchanged.

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

Marchiol, A., Sanchez, A.C.F., Caicedo, A., Segura, Marvi., Bautista, Jessica., Sotelo, M.S.A., Herazo, R., Forsyth, C., Bohorquez, L.C. (2023). Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia. https://doi.org/10.1371/journal.pntd.0011547

For more information, download instructions for use via the “Downloads” tab.

 Important: Read the package insert for complete details before performing this test.

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