A Highly Sensitive Rapid Diagnostic Test for Chagas Disease That Utilizes a Recombinant Trypanosoma cruzi Antigen

C. A. BARFIELD; R. S. BARNEY; C. H. CRUDDER; J. L. WILMOTH; D. S. STEVENS; SANTIAGO MORA-GARCIA; MARCELO YANOVSKY; B. H. WEIGL; J. YANOVSKY

IEEE TRANSACTIONS ON BIO-MEDICAL ENGINEERING

IEEE-INST ELECTRICAL ELECTRONICS ENGINEERS INC

Año: 2011 vol. 58 p. 814 - 817

0018-9294

Improved diagnostic tests for Chagas disease are urgently needed. A new lateral flow rapid test for Chagas disease is under development at PATH, in collaboration with Laboratorio Lemos of Argentina, which utilizes a recombinant antigen for detection of antibodies to Trypanosoma cruzi. To evaluate the performance of this test, 375 earlier characterized serum specimens from a region where Chagas is endemic were tested using a reference test (the Ortho T. cruzi ELISA, Johnson & Johnson), a commercially available rapid test (Chagas STAT-PAK, Chembio), and the PATH-Lemos rapid test. Compared to the composite reference tests, the PATH-Lemos rapid test demonstrated an optimal sensitivity of 99.5% and specificity of 96.8%, while the Chagas STAT-PAK demonstrated a sensitivity of 95.3% and specificity of 99.5%. These results indicate that the PATH-Lemos rapid test shows promise as an improved and reliable tool for screening and diagnosis of Chagas disease.