Chagas’ disease diagnosis: a multicentric evaluation of Chagas Stat-Pak, a rapid immunochromatographic assay with recombinant proteins of Trypanosoma cruzi
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. © 2003
Elsevier Inc. All rights reserved.
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Información Adicional
Correo Electrónico | nanes@ula.ve rafael.rangelaldao@gmail.com |
Editor | Diagnostic Microbiology and Infectious Disease 46 (2003) 265-271. Parasitology |
Colación | 265-271 |