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IEEE Trans Biomed Eng. 2011 Mar;58(3):814-7. doi: 10.1109/TBME.2010.2087334.

A highly sensitive rapid diagnostic test for Chagas disease that utilizes a recombinant Trypanosoma cruzi antigen.

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  • 1PATH, Seattle, WA 98121, USA. cbarfield@path.org

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.

PMID:
21342808
[PubMed - indexed for MEDLINE]
PMCID:
PMC3134275
Free PMC Article

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