Comparative Evaluation of 11 Commercialized Rapid Diagnostic Tests for Detecting Trypanosoma cruzi Antibodies in Serum Banks in Areas of Endemicity and Nonendemicity

Abstract

; Universidad Antonio Nariño (UAN), Bogotá, Colombia o Chagas disease is one of the main public health issues in Latin America. Increasingly during the past few decades, Trypanosoma cruzi infection has been detected in North America, Europe, and the Western Pacific, mainly as a result of population movement. The limited availability of rapid serological diagnostic tests hinders rapid diagnosis and early treatment in areas of endemicity and nonendemicity. In collaboration with 11 national reference laboratories (NRLs) from different geographical areas, we evaluated the performances of commercialized serological rapid diagnostic tests (RDT) for T. cruzi infection. Eleven commercialized T. cruzi infection RDTs were evaluated on a total of 474 samples extensively tested with at least three different techniques for Chagas disease, maintained at controlled low temperatures, and stored in the serum banks of the 11 NRLs. We measured the sensitivity, specificity, and concordance of each RDT and provided an additional questionnaire to evaluate its ease of use. The selected RDTs in this study were performed under controlled laboratory conditions. Out of the 11 RDTs, we found 8 of them to be useful, with the cassette format favored over the strip. We did not observe significant differences in RDT performances in the different regions. Overall, the performance results were lower than those disclosed by the manufacturers. The results of this evaluation validate the possibility of using RDTs to diagnose Chagas disease, thereby decreasing the time to treatment at a primary health care facility for patients who are willing to be treated. Further studies should be conducted in the laboratory and in the field to confirm these data, expressly to evaluate reproducibility in resource-limited settings, or using whole blood in clinical settings in areas of endemicity and nonendemicity.

2 nd Brazilian Consensus on Chagas Disease, 2015

“…However, further studies should be conducted in the laboratory and in the field to confirm these data, in particular assessing their reproducibility in the context of limited resources or the use of whole blood in the real contexts of endemic and non-endemic areas (153) .…”

Field Evaluation of the InBios Chagas Detect Plus Rapid Test in Serum and Whole-Blood Specimens in Bolivia

“…A recent multicenter evaluation of 11 rapid tests in serum showed sensitivities ranging from 10.6 to 97.2% and specificities ranging from 70.7 to 97% (14). Several rapid tests have shown high sensitivity and specificity in their initial evaluations (16) but less favorable results when later tested in field trials or against a larger panel of specimens (14,17).…”

“…Several rapid tests have shown high sensitivity and specificity in their initial evaluations (16) but less favorable results when later tested in field trials or against a larger panel of specimens (14,17). In initial evaluations in serum, sensitivity and specificity were reported to be 98.5% and 94.8% for the Chagas Stat-Pak (16) and 99.2% and 99.1% for the InBios TrypanosomaDetect (10).…”

“…If the results of one assay were considered equivocal, concordant results by at least two other assays were required to define the final status of a specimen. The WHO definition is one commonly used in evaluations of rapid tests (13,14).…”

Characterization and Diagnostic Application of Trypanosoma cruzi Trypomastigote Excreted-Secreted Antigens Shed in Extracellular Vesicles Released from Infected Mammalian Cells

“…and Trypanosoma rangeli (17). Consequently, the Pan American Health Organization has recommended (18) the use of two different assays for a confirmatory diagnosis of Chagas infection (19)(20)(21). A typical serological method recommended for confirming Chagas disease uses the trypomastigote excretory-secretory antigens (TESA) either in an ELISA or immunoblotting format to detect antibodies that cross-react with proteins or glycoconjugates released by T. cruzi (22)(23)(24)(25).…”