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 language | English |
|---|---|
| Article number | e0007271 |
| Journal | PLoS Neglected Tropical Diseases |
| Volume | 13 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - May 2019 |
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ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health
- Infectious Diseases
Cite this
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 journal › Article
}
TY - JOUR
T1 - Rapid immunochromatographic tests for the diagnosis of chronic chagas disease in at-risk populations
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
PY - 2019/5
Y1 - 2019/5
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.
UR - http://www.scopus.com/inward/record.url?scp=85068086756&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85068086756&partnerID=8YFLogxK
U2 - 10.1371/journal.pntd.0007271
DO - 10.1371/journal.pntd.0007271
M3 - Article
C2 - 31150377
AN - SCOPUS:85068086756
VL - 13
JO - PLoS Neglected Tropical Diseases
JF - PLoS Neglected Tropical Diseases
SN - 1935-2727
IS - 5
M1 - e0007271
ER -