Dataset Information

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

ABSTRACT:

Background

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.

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.

SUBMITTER: Angheben A

PROVIDER: S-EPMC6561601 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

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

Angheben Andrea A Buonfrate Dora D Cruciani Mario M Jackson Yves Y Alonso-Padilla Julio J Gascon Joaquim J Gobbi Federico F Giorli Giovanni G Anselmi Mariella M Bisoffi Zeno Z

PLoS neglected tropical diseases 20190531 5

<h4>Background</h4>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.<h4>Methods/principal findings</h4>We undertook a comprehensive search of the following databases: P ...[more]

PMID: 31150377

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Project description:BACKGROUND: Most current guidelines recommend two serological tests to diagnose chronic Chagas disease. When serological tests are persistently inconclusive, some guidelines recommend molecular tests. The aim of this investigation was to review chronic Chagas disease diagnosis literature and to summarize results of ELISA and PCR performance. METHODS: A systematic review was conducted searching remote databases (MEDLINE, LILACS, EMBASE, SCOPUS and ISIWeb) and full texts bibliography for relevant abstracts. In addition, manufacturers of commercial tests were contacted. Original investigations were eligible if they estimated sensitivity and specificity, or reliability -or if their calculation was possible - of ELISA or PCR tests, for chronic Chagas disease. RESULTS: Heterogeneity was high within each test (ELISA and PCR) and threshold effect was detected only in a particular subgroup. Reference standard blinding partially explained heterogeneity in ELISA studies, and pooled sensitivity and specificity were 97.7% [96.7%-98.5%] and 96.3% [94.6%-97.6%] respectively. Commercial ELISA with recombinant antigens studied in phase three investigations partially explained heterogeneity, and pooled sensitivity and specificity were 99.3% [97.9%-99.9%] and 97.5% [88.5%-99.5%] respectively. ELISA's reliability was seldom studied but was considered acceptable. PCR heterogeneity was not explained, but a threshold effect was detected in three groups created by using guanidine and boiling the sample before DNA extraction. PCR sensitivity is likely to be between 50% and 90%, while its specificity is close to 100%. PCR reliability was never studied. CONCLUSIONS: Both conventional and recombinant based ELISA give useful information, however there are commercial tests without technical reports and therefore were not included in this review. Physicians need to have access to technical reports to understand if these serological tests are similar to those included in this review and therefore correctly order and interpret test results. Currently, PCR should not be used in clinical practice for chronic Chagas disease diagnosis and there is no PCR test commercially available for this purpose. Tests limitations and directions for future research are discussed.

Project description:Background and purposeAccurate aphasia diagnosis is important in stroke care. A wide range of language tests are available and include informal assessments, tests developed by healthcare institutions and commercially published tests available for purchase in pre-packaged kits. The psychometrics of these tests are often reported online or within the purchased test manuals, not the peer-reviewed literature, therefore the diagnostic capabilities of these measures have not been systematically evaluated. This review aimed to identify both commercial and non-commercial language tests and tests used in stroke care and to examine the diagnostic capabilities of all identified measures in diagnosing aphasia in stroke populations.MethodsLanguage tests were identified through a systematic search of 161 publisher databases, professional and resource websites and language tests reported to be used in stroke care. Two independent reviewers evaluated test manuals or associated resources for cohort or cross-sectional studies reporting the tests' diagnostic capabilities (sensitivity, specificity, likelihood ratios or diagnostic odds ratios) in differentiating aphasic and non-aphasic stroke populations.ResultsFifty-six tests met the study eligibility criteria. Six "non-specialist" brief screening tests reported sensitivity and specificity information, however none of these measures reported to meet the specific diagnostic needs of speech pathologists. The 50 remaining measures either did not report validity data (n = 7); did not compare patient test performance with a comparison group (n = 17); included non-stroke participants within their samples (n = 23) or did not compare stroke patient performance against a language reference standard (n = 3). Diagnostic sensitivity analysis was completed for six speech pathology measures (WAB, PICA, CADL-2, ASHA-FACS, Adult FAVRES and EFA-4), however all studies compared aphasic performance with that of non-stroke healthy controls and were consequently excluded from the review.ConclusionsNo speech pathology test was found which reported diagnostic data for identifying aphasia in stroke populations. A diagnostically validated post-stroke aphasia test is needed.

Dataset Information

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

Background

Methods/principal findings

Conclusions/significance

Publications

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

Similar Datasets

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