Abstract
BackgroundDespite of a high disease burden, mainly in Latin America, Chagas disease (CD) is underdiagnosed and undertreated. Rapid diagnostic tests (RDTs) might improve the access to diagnosis. The aim of this study is to review the accuracy of commercially available RDTs used in field conditions for the diagnosis of chronic CD in populations at risk, in endemic and non-endemic countries.Methods/Principal findingsWe undertook a comprehensive search of the following databases: PubMed, SCOPUS, LILACS (last up-date on the 01st July, 2017), without language or date limits. Non-electronic sources have been also searched. This review included clinical studies with cohort recruitment of individuals at risk of T. cruzi exposure, without age limits; adequate reference standards for the diagnosis of CD. We excluded case-control studies and those testing RDTs during acute CD. Data on test accuracies were pooled through a bivariate random-effects model. Only one index test was evaluated separately. Geographical area, commercial brand, disease prevalence, study size, and risk of bias were explored as possible source of heterogeneity. Values of sensitivity and specificity were computed to obtain summary positive/negative likelihood ratios, and summary diagnostic odds ratio. Ten studies were included on six different immunochromatographic RDTs. The pooled sensitivity and specificity of the RDTs resulted 96.6% (95% CI 91.3–98.7%) and 99.3% (95% CI 98.4–99.7%), respectively. Test accuracy was particularly good in endemic areas (98.07%/99.03% of sensitivity/specificity, respectively). One test (Stat-Pak) showed an overall sensitivity of 97% (95% CI 87.6–99.3) and specificity of 99.4% (95% CI 98.6–99.8).Conclusions/SignificanceRDTs demonstrated to be sufficiently accurate to recommend their use for screening in endemic areas, even as stand-alone tests. This approach might increase the accessibility to the diagnosis. However, an additional confirmatory test in case of positive result remains a prudent approach.
Highlights
Chagas disease (CD) is a parasitic disease affecting more than 8 million people and causing 806,170 DALYs lost, annually, in the endemic countries of Latin America (LA)[1]
Inclusion criteria a) clinical studies with cohort recruitment in field conditions; b) the presence of adequate reference tests for the diagnosis of CD, namely a combination of two serological tests based on different techniques and antigens according to current World Health Organization (WHO) recommendations[8], or one or more high specificity test such as radioimmunoprecipitation analysis—RIPA or immunoblot or western blot, or the use of latent class analysis (LCA)-based reference standard; c) studies conducted on individuals with epidemiological risk of exposure to T. cruzi such as living in endemic area for at least one month, receiving blood transfusion in an endemic country or being born to a Latin American mother
The accuracy of all Rapid diagnostic tests (RDTs) under study can be considered sufficiently good to recommend their use in endemic settings, in the Southern Cone of LA, in order to increase access to diagnosis
Summary
Chagas disease (CD) is a parasitic disease affecting more than 8 million people and causing 806,170 DALYs lost, annually, in the endemic countries of Latin America (LA)[1]. It is caused by the protozoan parasite Trypanosoma cruzi, generally transmitted by insect vectors. Infections in the acute phase and, to a lesser extent the chronic one, can be treated with the aim of cure and interruption of transmission, or at least a reduction in the risk of morbidity[5]. The aim of this study is to review the accuracy of commercially available RDTs used in field conditions for the diagnosis of chronic CD in populations at risk, in endemic and nonendemic countries
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