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https://www.arca.fiocruz.br/handle/icict/62099
DIAGNOSTIC PERFORMANCE OF TWO DOMAINS DERIVED FROM A NOVEL TRYPANOSOMA CRUZI PROTEIN TO CHRONIC CHAGAS DISEASE IN ENDEMIC AREAS OF BRAZIL.
Author
Affilliation
Instituto de Investigaciones en Ingeniería Genética y Biología Molecular “Dr. Héctor N. Torres” (INGEBI-CONICET). Buenos Aires, Argentina.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Instituto de Investigaciones en Ingeniería Genética y Biología Molecular “Dr. Héctor N. Torres” (INGEBI-CONICET). Buenos Aires, Argentina.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Instituto de Investigaciones en Ingeniería Genética y Biología Molecular “Dr. Héctor N. Torres” (INGEBI-CONICET). Buenos Aires, Argentina.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Instituto de Investigaciones en Ingeniería Genética y Biología Molecular “Dr. Héctor N. Torres” (INGEBI-CONICET). Buenos Aires, Argentina.
Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.
Instituto de Investigaciones en Ingeniería Genética y Biología Molecular “Dr. Héctor N. Torres” (INGEBI-CONICET). Buenos Aires, Argentina.
Abstract
Chronic Chagas disease (CCD), a potentially life-threatening ill the OD of the cut-off, where RI >1.00 were considered positive. ness, is an infection caused by Trypanosoma cruzi parasite. In this To evaluate the overall precision for each antigen, areas under stage, the WHO advises using at least two distinct IgG-based the ROC curve (AUC) were performed. The AUC values were tests for a reliable diagnosis, due to the lack of a “gold-standard” 92.89% and 92.11% for D3 and D6, respectively. Both domains laboratory technique. Recently, we demonstrated the diagnosis exhibited 97.92% specificity while D3 was 79.51% sensitive and performance of two domains (D3 and D6) derived from a hypo D6 81.48%. The accuracy of D6 was 90.8% compared to the low thetical T. cruzi protein, named Tc323, which has no homologs er value for D3 (89.95%). Assuming an inconclusive range of RI in T. brucei or Leishmania genomes. For this, we used plasma values within 1.0 ± 0.10, 13 (3.95%), and 16 (4.86%) true positive of patients with CCD and non-infected donors from Argentina, samples tested against D3 and D6, respectively, led to false re Bolivia, and Paraguay. Here, we extended our work by testing sults. By analyzing the true negative samples, 4 (0.75%) fell in plasma of individuals with CCD or infected with unrelated dis side the inconclusive space using D3 and only 1 (0.18%) using eases living in endemic regions of Brazil. After the optimization D6. The incidence of cross-reactivity was almost negligible: only of our indirect ELISA, recombinant D3 and D6 proteins were as 4 out of 748 plasmas displayed seroreactivity using D3, while 5 sessed by employing plasma of 405 T. cruzi-positive and 530 samples generated false positives using D6. In both cases, sam T. cruzi-negative individuals from distinct areas of Brazil. Addi ples came from patients infected with Leptospira or Leishmania. tionally, 748 samples from donors with unrelated diseases were However, no reactivity was detected with plasma from individuo included to evaluate cross-reactivity. The receiver operating als with dengue, filariasis, HBV, HCV, HIV, rubella, schistosomia characteristic (ROC) curve was used to define the cut-off value sis, syphilis, COVID, leprosy and toxoplasmosis. with the best diagnostic performance for each ELISA assay us
Our results demonstrated a noteworthy performance of D3 and ing pooled plasma samples from positive and negative donors. D6 for the diagnosis of CCD individuals from endemic areas of The results were expressed as reactivity index (RI), calculated Brazil. Even more, both domains showed insignificant cross-re as the ratio between the optical density (OD) of the samples and activity with non-related infectious diseases.
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