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Memorias del Instituto de Investigaciones en Ciencias de la Salud

On-line version ISSN 1812-9528


ARIA, Laura et al. ELISA Chagas test IICS V.1 evaluation for the diagnosis of Chagas disease. Mem. Inst. Investig. Cienc. Salud [online]. 2016, vol.14, n.3, pp.7-13. ISSN 1812-9528.

In Paraguay, the serological screening for Chagas disease is mandatory in pregnant women and blood banks, therefore a high sensitivity diagnostic method is required. The aim of this study was to evaluate the ELISA Chagas test IICS V.1 by comparison with commercial kits and to analyze the external and internal quality evaluation results. In this descriptive observational study, 56 seropositive and seronegative to Trypanosoma cruzi samples were analyzed, obtaining an excellent concordance between the ELISA Chagas test IICS V.1 andthese commercial kits: Chagatest ELISA-Wiener, Argentina (kappa index: 0.89) and Test ELISA Chagas III-Grupo Bios, Chile (kappa index: 0.92).In the external quality assessment carried out by the Fundação Pró-Sangue /Blood Center of São Paulo, Brazil in the period 2001 to 2012, 450 samples were analyzed: 372 seronegative and 78 seropositive for T. cruzi. In this evaluation, an "A" score was obtained indicating the absence of false positives and negatives. Additionally, in the same period of time the internal control values were within the accepted range of ± 2SD, with a confidence interval of 95%. The results obtained in the present study demonstrate the high quality of this locally produced test which added to its low cost, making it a valid and useful tool to support the diagnosis of Chagas disease.

Keywords : Chagas; T. cruzi; evaluation program; internal control.

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