Comparative evaluation of four rapid diagnostic tests that detect human Trypanosoma cruzi-specific antibodies to support diagnosis of Chagas Disease in urban population of Argentina

• Published in: PLoS neglected tropical diseases Vol. 18; no. 3; p. e0011997
• Main Authors: Rivero, Rocío, Santini, M Soledad, Lopez-Albizu, Constanza, Rodriguez, Marcelo, Calbosa, Adriana, Oliveto, Daniela, Esteva, Mónica, Bisio, Margarita, Bohorquez, Laura C
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 01.03.2024; Public Library of Science (PLoS)
• Subjects: Algorithms; Antibodies; Antibodies, Protozoan; Argentina - epidemiology; Biology and Life Sciences; Chagas disease; Chagas Disease - diagnosis; Chagas Disease - epidemiology; Chemical contaminants; Chronic infection; Confidence intervals; Diagnosis; Diagnostic systems; Diagnostic tests; Estimates; Evaluation; Health aspects; Health care; Humans; Identification and classification; Infections; Laboratories; Lower bounds; Manufacturers; Medical tests; Medicine and Health Sciences; Methods; Parasites; People and places; Performance evaluation; Physical Sciences; Protozoa; Public health; Rapid Diagnostic Tests; Research and Analysis Methods; Retrospective Studies; Sample size; Sensitivity and Specificity; Serological tests; Serology; Trypanosoma; Trypanosoma cruzi; Urban Population; Urban populations; Vector-borne diseases; Argentina; United States > US; Latin America
• ISSN: 1935-2735; 1935-2727; 1935-2735
• DOI: 10.1371/journal.pntd.0011997

Chagas disease (CD), caused by the parasite Trypanosoma cruzi, is the most important endemic anthropozoonosis in Argentina. Since 2010, the World Health Organization has highlighted the urgent need to validate diagnostic systems that allow rapid detection of T. cruzi, infection in primary healthcare centers. Serological rapid diagnostic tests (RDTs) for T. cruzi, infection could be used to improve case management, as RDTs do not require specialized laboratories or highly trained staff to use them. We aimed to generate unbiased performance data of RDTs in Argentina, to evaluate their usefulness for improving T. cruzi, diagnosis rates. This is a retrospective, laboratory-based, diagnostic evaluation study to estimate the clinical sensitivity/specificity of four commercially available RDTs for T. cruzi, using the Chagas disease diagnostic algorithm currently used in Argentina as the reference standard. In total, 400 serum samples were tested, 200 from individuals with chronic T. cruzi infection and 200 from individuals not infected with T. cruzi. All results were registered as the agreement of at least two operators who were blinded to the reference standard results. The sensitivity estimates ranged from 92.5-100% (95% confidence interval (CI) lower bound 87.9-98.2%); for specificity, the range was 76-96% (95% CI lower bound 69.5-92.3%). Most RDTs evaluated showed performances comparable with the reference standard method, showing almost perfect concordance (Kappa 0.76-0.92). Our study demonstrates that, under controlled laboratory conditions, commercially available RDTs for CD have a performance comparable to the Argentinian diagnostic algorithm, which is based on laboratory-based serological tests. For the next stage of our work, the RDTs will be evaluated in real-world settings.