Resumo

ACOSTA-DE HETTER, María Eugenia et al. Performance of the IICS-UNA Chagas V2.0 Kit for screening of the disease. Mem. Inst. Investig. Cienc. Salud [online]. 2022, vol.20, n.3, pp.6-12. ISSN 1812-9528.  https://doi.org/10.18004/mem.iics/1812-9528/2022.020.03.06.

In Paraguay, Chagas disease is endemic, with approximately 165,000 infected people and 30% of the exposed population according to 2012 records. The objective of this study was to evaluate the ELISA Chagas test IICS V2.0 for screening of the disease in blood donor samples. We carried out a cross-sectional study of diagnostic tests, including 775 serum samples from two blood banks, and then calculating sensitivity, positive and negative values and the ROC curve. We also determined the concordance and correlation between the ELISA Chagas test IICS V2.0 and commercial ELISA. In the 775 blood bank samples analyzed, the Chagas ELISA test IICS V2.0 obtained a sensitivity of 99%, specificity of 96%, PPV 96%, NPV 99% and a kappa index equal to 0.95 (0.93-0.97) Standard Error (SE) 0.01 and p>0.0001 and the ROC area equal to 0.9835. Regarding the concordance with the commercial test, the kappa index was 0.926 CI95% (0.888-0.976), p=0.00001 and the correlation coefficient r=0.971 CI95%(0.962-0.978) p=0.0001.The concordances obtained were very good with respect to the serology of the blood bank samples as compared to the commercial test, allowing the use of the Chagas IICS V2 kit for the disease screening.

Palavras-chave : chagas disease; screening; blood bank; sensitivity; specificity; specificity.

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