title: A highly sensitive rapid diagnostic test for Chagas disease that utilizes a recombinant Trypanosoma cruzi antigen.
abstract: 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.
authors.affiliation: PATH, Seattle, WA 98121, USA. cbarfield@path.org
authors.forename: C A
authors.initials: CA
authors.lastname: Barfield
authors.forename: R S
authors.initials: RS
authors.lastname: Barney
authors.forename: C H
authors.initials: CH
authors.lastname: Crudder
authors.forename: J L
authors.initials: JL
authors.lastname: Wilmoth
authors.forename: D S
authors.initials: DS
authors.lastname: Stevens
authors.forename: S
authors.initials: S
authors.lastname: Mora-Garcia
authors.forename: M J
authors.initials: MJ
authors.lastname: Yanovsky
authors.forename: B H
authors.initials: BH
authors.lastname: Weigl
authors.forename: J
authors.initials: J
authors.lastname: Yanovsky
mesh_terms: D000913:Antibodies, Protozoan / Q000097:blood; D000953:Antigens, Protozoan / Q000276:immunology*; D014355:Chagas Disease / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D019095:Point-of-Care Systems; D011994:Recombinant Proteins / Q000276:immunology; D012680:Sensitivity and Specificity; D014349:Trypanosoma cruzi / Q000276:immunology*
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D011994:Recombinant Proteins