TY - JOUR T1 - A highly sensitive rapid diagnostic test for Chagas disease that utilizes a recombinant Trypanosoma cruzi antigen. JF - IEEE Trans Biomed Eng Y1 - 2011 A1 - Barfield, C A A1 - Barney, R S A1 - Crudder, C H A1 - Wilmoth, J L A1 - Stevens, D S A1 - Mora-Garcia, S A1 - Yanovsky, M J A1 - Weigl, B H A1 - Yanovsky, J KW - Antibodies, Protozoan KW - Antigens, Protozoan KW - Chagas Disease KW - Humans KW - Immunoassay KW - Point-of-Care Systems KW - Recombinant Proteins KW - Sensitivity and Specificity KW - Trypanosoma cruzi AB -

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.

VL - 58 IS - 3 U1 - http://www.ncbi.nlm.nih.gov/pubmed/21342808?dopt=Abstract ER -