Rapid immunochromatographic tests for the diagnosis of chronic chagas disease in at-risk populations: A systematic review and meta-analysis

Andrea Angheben, Dora Buonfrate, Mario Cruciani, Yves Jackson, Julio Alonso-Padilla, Joaquim Gascon, Federico Gobbi, Giovanni Giorli, Mariella Anselmi, Zeno Bisoffi

Research output: Contribution to journalArticle

Abstract

Background Despite of a high disease burden, mainly in Latin America, Chagas disease (CD) is underdi-agnosed 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 nonendemic countries. Methods/Principal findings We 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/Significance RDTs 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.

Original languageEnglish
Article numbere0007271
JournalPLoS Neglected Tropical Diseases
Volume13
Issue number5
DOIs
Publication statusPublished - May 2019

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Chagas Disease
Routine Diagnostic Tests
Meta-Analysis
Chronic Disease
Sensitivity and Specificity
Latin America
Acute Disease
PubMed
Case-Control Studies
Language
Cross-Sectional Studies
Odds Ratio
Databases

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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Rapid immunochromatographic tests for the diagnosis of chronic chagas disease in at-risk populations : A systematic review and meta-analysis. / Angheben, Andrea; Buonfrate, Dora; Cruciani, Mario; Jackson, Yves; Alonso-Padilla, Julio; Gascon, Joaquim; Gobbi, Federico; Giorli, Giovanni; Anselmi, Mariella; Bisoffi, Zeno.

In: PLoS Neglected Tropical Diseases, Vol. 13, No. 5, e0007271, 05.2019.

Research output: Contribution to journalArticle

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abstract = "Background Despite of a high disease burden, mainly in Latin America, Chagas disease (CD) is underdi-agnosed 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 nonendemic countries. Methods/Principal findings We 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/Significance RDTs 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.",
author = "Andrea Angheben and Dora Buonfrate and Mario Cruciani and Yves Jackson and Julio Alonso-Padilla and Joaquim Gascon and Federico Gobbi and Giovanni Giorli and Mariella Anselmi and Zeno Bisoffi",
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T2 - A systematic review and meta-analysis

AU - Angheben, Andrea

AU - Buonfrate, Dora

AU - Cruciani, Mario

AU - Jackson, Yves

AU - Alonso-Padilla, Julio

AU - Gascon, Joaquim

AU - Gobbi, Federico

AU - Giorli, Giovanni

AU - Anselmi, Mariella

AU - Bisoffi, Zeno

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N2 - Background Despite of a high disease burden, mainly in Latin America, Chagas disease (CD) is underdi-agnosed 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 nonendemic countries. Methods/Principal findings We 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/Significance RDTs 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.

AB - Background Despite of a high disease burden, mainly in Latin America, Chagas disease (CD) is underdi-agnosed 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 nonendemic countries. Methods/Principal findings We 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/Significance RDTs 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.

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