Chagas' disease diagnosis: A multicentric evaluation of Chagas Stat-Pak, a rapid immunochromatographic assay with recombinant proteins of Trypanosoma cruzi

Alejandro O. Luquetti, Carlos Ponce, Elisa Ponce, Javan Esfandiari, Alejandro Schijman, Susana Revollo, Nestor Añez, Bianca Zingales, Rafael Ramgel-Aldao, Antonio Gonzalez, Mariano J. Levin, Eufrosina S. Umezawa, José Franco Da Silveira

Research output: Contribution to journalArticlepeer-review

84 Scopus citations

Abstract

A rapid serologic test for diagnosis of T. cruzi infection (Chagas Stat Pak) was developed using recombinant proteins in an immunochromatographic assay. This cassette format test was evaluated first in blind with a panel of 393 coded serum samples. The Chagas Stat-Pak identified 197 infected (98.5% sensitivity) and 183 non-infected individuals (94.8% specificity). A second evaluation was performed with 352 sera from four Latin America countries tested independently in each country, showing a sensitivity of 100% and specificity of 98.6%. A third set of tests comparing sera with plasma and eluates from filter paper as well as serum preserved in 50% glycerol did show identical results as those obtained with serum. This rapid test (15 min) uses one device per sample, does not require refrigeration nor a laboratory structure or specialized skills to be performed, accepts different types of samples and may be stored for long periods of time for result checking and documentation. These attributes together with the high sensitivity and specificity demonstrated herein, make this test a suitable tool for field studies, small laboratories and emergencies at blood banks in the countryside of endemic areas.

Original languageEnglish
Pages (from-to)265-271
Number of pages7
JournalDiagnostic Microbiology and Infectious Disease
Volume46
Issue number4
DOIs
StatePublished - 1 Aug 2003
Externally publishedYes

Bibliographical note

Funding Information:
This work was supported by CYTED (Ibero American Project of Biotechnology), FAPESP and CNPq. Technical assistance of Rosangela Amaral Oliveira and Siulene B. Nascimento Tavares is duly acknowledged. We also thank Daniela V. Luquetti for the English review.

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