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dc.contributor.authorPage, Anne-Laure
dc.contributor.authorAlberti, Kathryn P.
dc.contributor.authorMondonge, Vital
dc.contributor.authorRauzier, Jean
dc.contributor.authorQuilici, Marie-Laure
dc.contributor.authorGuerin, Philippe J.
dc.contributor.authorBhutta, Zulfiqar A.
dc.date.accessioned2012-09-10T19:45:11Z
dc.date.available2012-09-10T19:45:11Z
dc.date.issued2012-05-30
dc.date.submitted2011-11-15
dc.identifier.citationPLoS ONE 7(5): e37360. doi:10.1371/journal.pone.0037360en_GB
dc.identifier.issn1932-6203
dc.identifier.doi10.1371/journal.pone.0037360
dc.identifier.urihttp://hdl.handle.net/10144/242362
dc.description.abstractEarly detection and confirmation of cholera outbreaks are crucial for rapid implementation of control measures. Because cholera frequently affects regions with limited laboratory resources, rapid diagnostic tests (RDT) designed for field conditions are important to enhance rapid response. Stool culture remains the ‘‘gold standard’’ for cholera diagnosis; however, its lack of sensitivity may lead to underestimation of test specificity. We evaluated the Crystal VCH immunochromatographic test (Span Diagnostics, India) for cholera diagnosis using a modified reference standard that combines culture-dependent and independent assays, or a Bayesian latent class model (LCM) analysis. The study was conducted during a cholera epidemic in 2008, in Lubumbashi, Democratic Republic of Congo. Stools collected from 296 patients were used to perform the RDT on site and sent to Institut Pasteur, Paris, for bacterial culture. In comparison with culture as the gold standard, the RDT showed good sensitivity (92.2%; 95% CI: 86.8%–95.9%) but poor specificity when used by a trained laboratory technician (70.6%; 95% CI: 60.7%–79.2%) or by clinicians with no specific test training (60.4%, 95% CI: 50.2%–70.0%). The specificity of the test performed by the laboratory technician increased to 88.6% (95% CI: 78.7–94.9) when PCR was combined with culture results as the reference standard, and to 85.0% (95% CI: 70.4–99.2), when the Bayesian LCM analysis was used for performance evaluation. In both cases, the sensitivity remained high. Using an improved reference standard or appropriate statistical methods for diagnostic test evaluations in the absence of a gold standard, we report better performance of the Crystal VCH RDT than previously published. Our results confirm that this test can be used for early outbreak detection or epidemiological surveillance, key components of efficient global cholera control. Our analysis also highlights the importance of improving evaluations of RDT when no reliable gold standard is available.
dc.language.isoenen
dc.publisherPublic Library of Scienceen_GB
dc.relation.urlhttp://dx.plos.org/10.1371/journal.pone.0037360en_GB
dc.rightsPublished by Public Library of Science, [url]http://www.plosone.org/[/url] Archived on this site by Open Access permissionen_GB
dc.subjectcholeraen_GB
dc.subjectrapid testen_GB
dc.titleEvaluation of a Rapid Test for the Diagnosis of Cholera in the Absence of a Gold Standarden
dc.typeArticleen
dc.contributor.departmentEpicentre, Paris, France; Ministry of Health, Kinshasa, Democratic Republic of Congo; Institut Pasteur, Unité des Bactéries Pathogènes Entériques, Centre National de Référence des Vibrions et du Choléra, Paris, France; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), University of Oxford, Oxford, United Kingdomen_GB
dc.identifier.journalPLoS ONEen_GB
refterms.dateFOA2019-03-04T09:58:48Z
html.description.abstractEarly detection and confirmation of cholera outbreaks are crucial for rapid implementation of control measures. Because cholera frequently affects regions with limited laboratory resources, rapid diagnostic tests (RDT) designed for field conditions are important to enhance rapid response. Stool culture remains the ‘‘gold standard’’ for cholera diagnosis; however, its lack of sensitivity may lead to underestimation of test specificity. We evaluated the Crystal VCH immunochromatographic test (Span Diagnostics, India) for cholera diagnosis using a modified reference standard that combines culture-dependent and independent assays, or a Bayesian latent class model (LCM) analysis. The study was conducted during a cholera epidemic in 2008, in Lubumbashi, Democratic Republic of Congo. Stools collected from 296 patients were used to perform the RDT on site and sent to Institut Pasteur, Paris, for bacterial culture. In comparison with culture as the gold standard, the RDT showed good sensitivity (92.2%; 95% CI: 86.8%–95.9%) but poor specificity when used by a trained laboratory technician (70.6%; 95% CI: 60.7%–79.2%) or by clinicians with no specific test training (60.4%, 95% CI: 50.2%–70.0%). The specificity of the test performed by the laboratory technician increased to 88.6% (95% CI: 78.7–94.9) when PCR was combined with culture results as the reference standard, and to 85.0% (95% CI: 70.4–99.2), when the Bayesian LCM analysis was used for performance evaluation. In both cases, the sensitivity remained high. Using an improved reference standard or appropriate statistical methods for diagnostic test evaluations in the absence of a gold standard, we report better performance of the Crystal VCH RDT than previously published. Our results confirm that this test can be used for early outbreak detection or epidemiological surveillance, key components of efficient global cholera control. Our analysis also highlights the importance of improving evaluations of RDT when no reliable gold standard is available.


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