Abstract
Chronic Chagas disease diagnosis relies on laboratory tests due to its clinical characteristics. The aim of this research was to review commercial enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) diagnostic test performance. Performance of commercial ELISA or PCR for the diagnosis of chronic Chagas disease were systematically searched in PubMed, Scopus, Embase, ISI Web, and LILACS through the bibliography from 1980-2014 and by contact with the manufacturers. The risk of bias was assessed with QUADAS-2. Heterogeneity was estimated with the I2 statistic. Accuracies provided by the manufacturers usually overestimate the accuracy provided by academia. The risk of bias is high in most tests and in most QUADAS dimensions. Heterogeneity is high in either sensitivity, specificity, or both. The evidence regarding commercial ELISA and ELISA-rec sensitivity and specificity indicates that there is overestimation. The current recommendation to use two simultaneous serological tests can be supported by the risk of bias analysis and the amount of heterogeneity but not by the observed accuracies. The usefulness of PCR tests are debatable and health care providers should not order them on a routine basis. PCR may be used in selected cases due to its potential to detect seronegative subjects.
Highlights
There is no consistent evidence that these procedures improve clinical polymerase chain reaction (PCR) performance for chronic Chagas disease diagnosis, this later strategy was previously applied for development of a diagnostic assay of other neglected tropical diseases using loop-mediated isothermal amplification (Dinzouna-Boutamba et al 2014)
This will probably occur when key issues are adopted, such as: consecutive inclusion of suspected subjects, a reference standard for chronic Chagas disease diagnosis widely accepted in the scientific community and research with later-phase designs
The current recommendation to use two simultaneous serological tests for chronic Chagas disease diagnosis is neither supported by the accuracies found in research papers nor the accuracies provided by the manufacturers
Summary
The abstracts were eligible for full text evaluation if their aims were at least one of the following: (i) to estimate sensitivity or specificity of one or more ELISA or PCR tests for chronic Chagas disease, (ii) to estimate the accuracy of an ELISA or PCR test for chronic Chagas disease, (iii) to test a new ELISA or PCR test for chronic Chagas disease, or (iv) to estimate any validity measure for ELISA or PCR for chronic Chagas disease such as the area under the receiver operating characteristics (ROC) curve or predictive values. If abstracts had unclear objectives but partially met any of the inclusion criteria, or had unclear objectives and had any of the validity measures (as described above) as a result, they were included for full text retrieval. The following inclusion criteria were applied for quality evaluation and data extraction: (i) the investigations should be original (narrative reviews, editorials, or letters without primary data were excluded), (ii) they should be quantitative investigations, (iii) every investigation must have two samples (1 representing those with chronic Chagas disease and another representing those without chronic Chagas disease), (iv) they must have results with enough data to allow extraction (or calculation) of true positives, false negatives, false positives, and true negatives of each test, and (v) they must not involve strictly laboratory validation research. Phase 3 studies are crosssectional or diagnostic cohort studies with the consecutive inclusion of subjects in which the suspicion of the condition of interest is the main inclusion criteria
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
