Performance comparison of the cobas Liat and Cepheid GeneXpert systems for Clostridium difficile detection
Clostridium difficile infection (CDI) is a high burden and significant cause of healthcare-acquired infectious diarrhea in the United States (US). Timely and accurate diagnosis of CDI enables the rapid initiation of antibiotic therapy and infection control policies to minimize disease transmission....
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| creator | Granato, Paul A Hansen, Glen Herding, Emily Chaudhuri, Sheena Tang, Shaowu Garg, Sachin K Rowell, Catherine R Sickler, Joanna Jackson |
| description | Clostridium difficile infection (CDI) is a high burden and significant cause of healthcare-acquired infectious diarrhea in the United States (US). Timely and accurate diagnosis of CDI enables the rapid initiation of antibiotic therapy and infection control policies to minimize disease transmission. Polymerase chain reaction (PCR) assays have become a preferred modality for diagnosing CDI in the US. The cobas Liat Cdiff PCR test is a novel assay that can be performed on-demand for hospital-based testing with a rapid 20-minute turnaround time from specimen collection to result reporting. We compared the clinical performance of the cobas Liat Cdiff test to the previously introduced Xpert C. difficile/Epi test; both tests are FDA-cleared PCR assays that detect the toxin B (tcdB) gene of C. difficile. Prospectively collected and remnant stool specimens from 310 patients with suspected CDI were obtained for analysis. The cobas Liat Cdiff and Xpert PCR tests showed an overall percent agreement of 97.4% (302/310; 95% CI: 95.0-98.9). Low bacterial burdens of toxigenic C. difficile, indicated by significantly delayed PCR cycle threshold (Ct) values, explained most of the discordance. Positive and negative percent agreement of the cobas Liat Cdiff test compared to the Xpert PCR test were 94.5% (52/55) and 98.0% (250/255), respectively. The clinical performance of the cobas Liat Cdiff test, combined with its simplicity of use and rapid result reporting, provides a reliable option for clinical laboratory use. |
| doi_str_mv | 10.1371/journal.pone.0200498 |
| format | Article |
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Timely and accurate diagnosis of CDI enables the rapid initiation of antibiotic therapy and infection control policies to minimize disease transmission. Polymerase chain reaction (PCR) assays have become a preferred modality for diagnosing CDI in the US. The cobas Liat Cdiff PCR test is a novel assay that can be performed on-demand for hospital-based testing with a rapid 20-minute turnaround time from specimen collection to result reporting. We compared the clinical performance of the cobas Liat Cdiff test to the previously introduced Xpert C. difficile/Epi test; both tests are FDA-cleared PCR assays that detect the toxin B (tcdB) gene of C. difficile. Prospectively collected and remnant stool specimens from 310 patients with suspected CDI were obtained for analysis. The cobas Liat Cdiff and Xpert PCR tests showed an overall percent agreement of 97.4% (302/310; 95% CI: 95.0-98.9). Low bacterial burdens of toxigenic C. difficile, indicated by significantly delayed PCR cycle threshold (Ct) values, explained most of the discordance. Positive and negative percent agreement of the cobas Liat Cdiff test compared to the Xpert PCR test were 94.5% (52/55) and 98.0% (250/255), respectively. The clinical performance of the cobas Liat Cdiff test, combined with its simplicity of use and rapid result reporting, provides a reliable option for clinical laboratory use.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0200498</identifier><identifier>PMID: 30040852</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Antibiotics ; Assaying ; Automation ; Bacteria ; Biology and Life Sciences ; Clostridium difficile ; Clostridium infections ; Control ; Diagnosis ; Diarrhea ; Discordance ; Disease control ; Disease transmission ; Enzymes ; Health aspects ; Health care ; Immunoassay ; Infections ; Laboratories ; Medical diagnosis ; Medicine and Health Sciences ; Methods ; People and places ; Polymerase chain reaction ; Research and Analysis Methods ; Risk factors ; Toxin B</subject><ispartof>PloS one, 2018-07, Vol.13 (7), p.e0200498</ispartof><rights>COPYRIGHT 2018 Public Library of Science</rights><rights>2018 Granato 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>2018 Granato et al 2018 Granato et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-e3d6317d3e32a8468c122e7c5e0ae2ea1c6a4dd6b80f6d65e2e3f466ddcc164f3</citedby><cites>FETCH-LOGICAL-c692t-e3d6317d3e32a8468c122e7c5e0ae2ea1c6a4dd6b80f6d65e2e3f466ddcc164f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057633/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057633/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30040852$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Popoff, Michel R.</contributor><creatorcontrib>Granato, Paul A</creatorcontrib><creatorcontrib>Hansen, Glen</creatorcontrib><creatorcontrib>Herding, Emily</creatorcontrib><creatorcontrib>Chaudhuri, Sheena</creatorcontrib><creatorcontrib>Tang, Shaowu</creatorcontrib><creatorcontrib>Garg, Sachin K</creatorcontrib><creatorcontrib>Rowell, Catherine R</creatorcontrib><creatorcontrib>Sickler, Joanna Jackson</creatorcontrib><title>Performance comparison of the cobas Liat and Cepheid GeneXpert systems for Clostridium difficile detection</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Clostridium difficile infection (CDI) is a high burden and significant cause of healthcare-acquired infectious diarrhea in the United States (US). Timely and accurate diagnosis of CDI enables the rapid initiation of antibiotic therapy and infection control policies to minimize disease transmission. Polymerase chain reaction (PCR) assays have become a preferred modality for diagnosing CDI in the US. The cobas Liat Cdiff PCR test is a novel assay that can be performed on-demand for hospital-based testing with a rapid 20-minute turnaround time from specimen collection to result reporting. We compared the clinical performance of the cobas Liat Cdiff test to the previously introduced Xpert C. difficile/Epi test; both tests are FDA-cleared PCR assays that detect the toxin B (tcdB) gene of C. difficile. Prospectively collected and remnant stool specimens from 310 patients with suspected CDI were obtained for analysis. The cobas Liat Cdiff and Xpert PCR tests showed an overall percent agreement of 97.4% (302/310; 95% CI: 95.0-98.9). Low bacterial burdens of toxigenic C. difficile, indicated by significantly delayed PCR cycle threshold (Ct) values, explained most of the discordance. Positive and negative percent agreement of the cobas Liat Cdiff test compared to the Xpert PCR test were 94.5% (52/55) and 98.0% (250/255), respectively. The clinical performance of the cobas Liat Cdiff test, combined with its simplicity of use and rapid result reporting, provides a reliable option for clinical laboratory use.</description><subject>Antibiotics</subject><subject>Assaying</subject><subject>Automation</subject><subject>Bacteria</subject><subject>Biology and Life Sciences</subject><subject>Clostridium difficile</subject><subject>Clostridium infections</subject><subject>Control</subject><subject>Diagnosis</subject><subject>Diarrhea</subject><subject>Discordance</subject><subject>Disease control</subject><subject>Disease transmission</subject><subject>Enzymes</subject><subject>Health aspects</subject><subject>Health care</subject><subject>Immunoassay</subject><subject>Infections</subject><subject>Laboratories</subject><subject>Medical diagnosis</subject><subject>Medicine and Health Sciences</subject><subject>Methods</subject><subject>People and places</subject><subject>Polymerase chain reaction</subject><subject>Research and 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| source | DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Antibiotics Assaying Automation Bacteria Biology and Life Sciences Clostridium difficile Clostridium infections Control Diagnosis Diarrhea Discordance Disease control Disease transmission Enzymes Health aspects Health care Immunoassay Infections Laboratories Medical diagnosis Medicine and Health Sciences Methods People and places Polymerase chain reaction Research and Analysis Methods Risk factors Toxin B |
| title | Performance comparison of the cobas Liat and Cepheid GeneXpert systems for Clostridium difficile detection |
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