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

被引：15

作者：

Barfield, C. A. ^{[1
]}

Barney, R. S. ^{[1
]}

Crudder, C. H. ^{[1
]}

Wilmoth, J. L. ^{[1
]}

Stevens, D. S. ^{[1
]}

Mora-Garcia, S. ^{[2
]}

Yanovsky, M. J. ^{[2
]}

Weigl, B. H. ^{[1
]}

Yanovsky, J. ^{[3
]}

机构：

[1] PATH, Seattle, WA 98121 USA

[2] Fdn Inst Leloir, Buenos Aires, DF, Argentina

[3] Lab Lemos, Buenos Aires, DF, Argentina

来源：

IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING | 2011年 / 58卷 / 03期

关键词：

Chagas disease; immunoassay; medical diagnosis; point of care (POC); IMMUNOCHROMATOGRAPHIC ASSAY; INFECTION;

D O I：

10.1109/TBME.2010.2087334

中图分类号：

R318 [生物医学工程];

学科分类号：

0831 ;

摘要：

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.

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收藏

页码：814 / 817

页数：4

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