Rapid immunochromatographic tests for the diagnosis of chronic Chagas disease in at-risk populations: A systematic review and meta-analysis
Despite 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 diag...
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| Veröffentlicht in: | PLoS neglected tropical diseases 2019-05, Vol.13 (5), p.e0007271-e0007271 |
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| creator | Angheben, Andrea Buonfrate, Dora Cruciani, Mario Jackson, Yves Alonso-Padilla, Julio Gascon, Joaquim Gobbi, Federico Giorli, Giovanni Anselmi, Mariella Bisoffi, Zeno |
| description | Despite 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.
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).
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. |
| doi_str_mv | 10.1371/journal.pntd.0007271 |
| format | Article |
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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).
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.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0007271</identifier><identifier>PMID: 31150377</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Accuracy ; Affinity chromatography ; Agglutination tests ; Antigens ; At risk populations ; Biology and Life Sciences ; Bivariate analysis ; Blood & organ donations ; Care and treatment ; Case-Control Studies ; Chagas disease ; Chagas Disease - diagnosis ; Chagas Disease - parasitology ; Cohort Studies ; Cohorts ; Cromatografia d'afinitat ; Diagnosis ; Diagnostic systems ; Diagnostic tests ; Diagnostic Tests, Routine - methods ; Diseases ; Genetic diversity ; Health risks ; Heterogeneity ; Hospitals ; Humans ; Immunoassay - methods ; Infections ; Infectious diseases ; Malaltia de Chagas ; Medical research ; Medical testing products ; Medical tests ; Medicine and Health Sciences ; Meta-analysis ; Parasitic diseases ; Population ; Populations ; Prevalence studies (Epidemiology) ; Primary care ; Protozoa ; Public health administration ; Ratios ; Research and Analysis Methods ; Reviews ; Risk ; Sensitivity ; Sensitivity and Specificity ; Specificity ; Systematic review ; Technology application ; Tests ; Tropical diseases ; Trypanosoma cruzi - genetics ; Trypanosoma cruzi - isolation & purification ; Vector-borne diseases</subject><ispartof>PLoS neglected tropical diseases, 2019-05, Vol.13 (5), p.e0007271-e0007271</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Angheben et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>cc by (c) Angheben et al., 2019 info:eu-repo/semantics/openAccess <a href="http://creativecommons.org/licenses/by/3.0/es/">http://creativecommons.org/licenses/by/3.0/es/</a></rights><rights>2019 Angheben et al 2019 Angheben et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c666t-fb496825b5162523cfc5d1fb2b213fa5c75216f8e448fa8c7cfc82b24b6ff3183</citedby><cites>FETCH-LOGICAL-c666t-fb496825b5162523cfc5d1fb2b213fa5c75216f8e448fa8c7cfc82b24b6ff3183</cites><orcidid>0000-0003-4545-8034 ; 0000-0003-0108-6822 ; 0000-0003-4466-7969 ; 0000-0001-5619-333X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6561601/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6561601/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,26951,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31150377$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Angheben, Andrea</creatorcontrib><creatorcontrib>Buonfrate, Dora</creatorcontrib><creatorcontrib>Cruciani, Mario</creatorcontrib><creatorcontrib>Jackson, Yves</creatorcontrib><creatorcontrib>Alonso-Padilla, Julio</creatorcontrib><creatorcontrib>Gascon, Joaquim</creatorcontrib><creatorcontrib>Gobbi, Federico</creatorcontrib><creatorcontrib>Giorli, Giovanni</creatorcontrib><creatorcontrib>Anselmi, Mariella</creatorcontrib><creatorcontrib>Bisoffi, Zeno</creatorcontrib><title>Rapid immunochromatographic tests for the diagnosis of chronic Chagas disease in at-risk populations: A systematic review and meta-analysis</title><title>PLoS neglected tropical diseases</title><addtitle>PLoS Negl Trop Dis</addtitle><description>Despite 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.
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).
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.</description><subject>Accuracy</subject><subject>Affinity chromatography</subject><subject>Agglutination tests</subject><subject>Antigens</subject><subject>At risk populations</subject><subject>Biology and Life Sciences</subject><subject>Bivariate analysis</subject><subject>Blood & organ donations</subject><subject>Care and treatment</subject><subject>Case-Control Studies</subject><subject>Chagas disease</subject><subject>Chagas Disease - diagnosis</subject><subject>Chagas Disease - parasitology</subject><subject>Cohort Studies</subject><subject>Cohorts</subject><subject>Cromatografia d'afinitat</subject><subject>Diagnosis</subject><subject>Diagnostic systems</subject><subject>Diagnostic tests</subject><subject>Diagnostic Tests, Routine - methods</subject><subject>Diseases</subject><subject>Genetic diversity</subject><subject>Health risks</subject><subject>Heterogeneity</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Immunoassay - methods</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Malaltia de Chagas</subject><subject>Medical research</subject><subject>Medical testing products</subject><subject>Medical tests</subject><subject>Medicine and Health Sciences</subject><subject>Meta-analysis</subject><subject>Parasitic diseases</subject><subject>Population</subject><subject>Populations</subject><subject>Prevalence studies (Epidemiology)</subject><subject>Primary care</subject><subject>Protozoa</subject><subject>Public health administration</subject><subject>Ratios</subject><subject>Research and Analysis Methods</subject><subject>Reviews</subject><subject>Risk</subject><subject>Sensitivity</subject><subject>Sensitivity and Specificity</subject><subject>Specificity</subject><subject>Systematic review</subject><subject>Technology application</subject><subject>Tests</subject><subject>Tropical diseases</subject><subject>Trypanosoma cruzi - genetics</subject><subject>Trypanosoma cruzi - 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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.
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).
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.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>31150377</pmid><doi>10.1371/journal.pntd.0007271</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0003-4545-8034</orcidid><orcidid>https://orcid.org/0000-0003-0108-6822</orcidid><orcidid>https://orcid.org/0000-0003-4466-7969</orcidid><orcidid>https://orcid.org/0000-0001-5619-333X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1935-2735 |
| ispartof | PLoS neglected tropical diseases, 2019-05, Vol.13 (5), p.e0007271-e0007271 |
| issn | 1935-2735 1935-2727 1935-2735 |
| language | eng |
| recordid | cdi_plos_journals_2252319363 |
| source | MEDLINE; Public Library of Science; Recercat; PubMed; Directory of Open Access Journals; EZB Electronic Journals Library; PubMed Central Open Access |
| subjects | Accuracy Affinity chromatography Agglutination tests Antigens At risk populations Biology and Life Sciences Bivariate analysis Blood & organ donations Care and treatment Case-Control Studies Chagas disease Chagas Disease - diagnosis Chagas Disease - parasitology Cohort Studies Cohorts Cromatografia d'afinitat Diagnosis Diagnostic systems Diagnostic tests Diagnostic Tests, Routine - methods Diseases Genetic diversity Health risks Heterogeneity Hospitals Humans Immunoassay - methods Infections Infectious diseases Malaltia de Chagas Medical research Medical testing products Medical tests Medicine and Health Sciences Meta-analysis Parasitic diseases Population Populations Prevalence studies (Epidemiology) Primary care Protozoa Public health administration Ratios Research and Analysis Methods Reviews Risk Sensitivity Sensitivity and Specificity Specificity Systematic review Technology application Tests Tropical diseases Trypanosoma cruzi - genetics Trypanosoma cruzi - isolation & purification Vector-borne diseases |
| title | Rapid immunochromatographic tests for the diagnosis of chronic Chagas disease in at-risk populations: A systematic review and meta-analysis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-07T16%3A10%3A05IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Rapid%20immunochromatographic%20tests%20for%20the%20diagnosis%20of%20chronic%20Chagas%20disease%20in%20at-risk%20populations:%20A%20systematic%20review%20and%20meta-analysis&rft.jtitle=PLoS%20neglected%20tropical%20diseases&rft.au=Angheben,%20Andrea&rft.date=2019-05-01&rft.volume=13&rft.issue=5&rft.spage=e0007271&rft.epage=e0007271&rft.pages=e0007271-e0007271&rft.issn=1935-2735&rft.eissn=1935-2735&rft_id=info:doi/10.1371/journal.pntd.0007271&rft_dat=%3Cgale_plos_%3EA587702529%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2252319363&rft_id=info:pmid/31150377&rft_galeid=A587702529&rft_doaj_id=oai_doaj_org_article_a53e99a1cd1440cfa023309954e030b5&rfr_iscdi=true |