Molecular diagnosis of Chagas disease: a systematic review and meta-analysis

Abstract

Background The complexity of the Chagas disease and its phases is impossible to have a unique test for both phases and a lot of diferent epidemiological scenarios. Currently, serology is the reference standard technique; occasion‑ ally, results are inconclusive, and a diferent diagnostic technique is needed. Some guidelines recommend molecular testing. A systematic review and meta-analysis of available molecular tools/techniques for the diagnosis of Chagas disease was performed to measure their heterogeneity and efcacy in detecting Trypanosoma cruzi infection in blood samples. Methods A systematic review was conducted up to July 27, 2022, including studies published in international databases. Inclusion and exclusion criteria were defned to select eligible studies. Data were extracted and presented according to PRISMA 2020 guidelines. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). A random-efects model was used to calculate pooled sensitivity, specifcity, and diagnostic odds ratio (DOR). Forest plots and a summary of the receiving operating characteristics (SROC) curves displayed the outcomes. Heterogeneity was determined by I2 and Tau2 statistics and P values. Funnel plots and Deek’s test were used to assess publication bias. A quantitative meta-analysis of the diferent outcomes in the two diferent clinical phases was performed. Results We identifed 858 records and selected 32 papers. Studies pertained to endemic countries and nonendemic areas with adult and paediatric populations. The sample sizes ranged from 17 to 708 patients. There were no concerns regarding the risk of bias and applicability of all included studies. A positive and nonsignifcant correlation coefcient (S=0.020; P=0.992) was obtained in the set of studies that evaluated diagnostic tests in the acute phase population (ACD). A positive and signifcant correlation coefcient (S=0.597; P<0.000) was obtained in the case of studies per‑ formed in the chronic phase population (CCD). This resulted in high heterogeneity between studies, with the master mix origin and guanidine addition representing signifcant sources. Interpretation/Conclusions and relevance The results described in this meta-analysis (qualitative and quantita‑ tive analyses) do not allow the selection of the optimal protocol of molecular method for the study of Trypanosoma cruzi infection in any of its phases, among other reasons due to the complexity of this infection. Continuous analysis and optimization of the diferent molecular techniques is crucial to implement this eficient diagnosis in endemic areas.