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

作者：Barfield C A^*; Barney R S; Crudder C H; Wilmoth J L; Stevens D S; Mora Garcia S; Yanovsky M J; Weigl B H; Yanovsky J

来源：IEEE Transactions on Biomedical Engineering, 2011, 58(3): 814-817.

DOI：10.1109/TBME.2010.2087334

• Chagas disease
• immunoassay
• medical diagnosis
• point of care (POC)

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.

• 出版日期2011-3