RESUMO
OBJECTIVE: To determine the diagnostic validity of the enzyme-linked immunosorbent assay (ELISA) and Rapid Diagnostic Tests (RDT) among individuals with suspected chronic Chagas Disease (CD). METHODOLOGY: A search was made for studies with ELISA and RDT assays validity estimates as eligibility criteria, published between 2010 and 2020 on PubMed, Web of Science, Scopus, and LILACS. This way, we extracted the data and assessed the risk of bias and applicability of the studies using the QUADAS-2 tool. The bivariate random effects model was also used to estimate the overall sensitivity and specificity through forest-plots, ROC space, and we visually assessed the heterogeneity between studies. Meta-regressions were made using subgroup analysis. We used Deeks' test to assess the risk of publication bias. RESULTS: 43 studies were included; 27 assessed ELISA tests; 14 assessed RDTs; and 2 assessed ELISA and RDTs, against different reference standards. 51.2 % of them used a non-comparative observational design, and 46.5 % a comparative clinical design ("case-control" type). High risk of bias was detected for patient screening and reference standard. The ELISA tests had a sensitivity of 99% (95% CI: 98-99) and a specificity of 98% (95% CI: 97-99); whereas the Rapid Diagnostic Tests (RDT) had values of 95% (95% CI: 94-97) and 97% (95% CI: 96-98), respectively. Deeks' test showed asymmetry on the ELISA assays. CONCLUSIONS: ELISA and RDT tests have high validity for diagnosing chronic Chagas disease. The analysis of these two types of evidence in this systematic review and meta-analysis constitutes an input for their use. The limitations included the difficulty in extracting data due to the lack of information in the articles, and the comparative clinical-type design of some studies.
Assuntos
Doença de Chagas , Testes Diagnósticos de Rotina , Humanos , Sensibilidade e Especificidade , Doença de Chagas/diagnóstico , Ensaio de Imunoadsorção Enzimática , Padrões de ReferênciaRESUMO
OBJECTIVE: To evaluate diagnostic precision of two rapid diagnostic tests (RDT's) on patients with chronic Chagas disease. METHODOLOGY: Prospective study with the following inclusion criteria: subjects older than 3 years, signed informed consent. Exclusion criterion: subjects could not have previously received treatment for infection with T. cruzi. The study population were participants in a screening process undertaken in rural and urban zones of the department Boyacá, Colombia. Two RDT's were performed to all participants: the Chagas Detect Plus InBios (CDP) and the Chagas Stat-Pak (CSP) and as a reference standard the ELISA Chagas III GrupoBios and the Chagas ELISA IgG+IgM I Vircell tests were used. In the case of discordant results between the two ELISA tests, an indirect immunofluorescence was done. RESULTS: Three hundred-five (305) subjects were included in the study (38 patients with leishmaniasis), of which 215 tested negative for T cruzi and 90 tested positive according to the reference standard. The sensitivity of the RDT's were 100% (CI 95% 95.9-100), and the specificity of the CDP was 99.1% (CI 95% 96.6-99.8) and for CSP was 100% (CI 95% 98.3-100). The agreement of CDP was 99.5% and for CSP was 100% with Kappa values of (k = 99.1; CI 95% 92.6-99.8%) and (k = 100; CI 95% 94.3-100), respectively. RDT's did not present cross-reactions with samples from patients who were positive for leishmaniasis. CONCLUSIONS: The findings demonstrate excellent results from the RDT's in terms of validity, safety, and reproducibility. The results obtained provide evidence for the recommendation for using these tests in a Colombian epidemiological context principally in endemic areas in which laboratory installations necessary to perform conventional tests are not available, or they are scarce and to help in diagnosing chronic Chagas disease in order to provide access to treatment as soon as possible.