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Evaluation of the Cepheid Xpert Clostridium difficile Epi Assay for Diagnosis of Clostridium difficile Infection and Typing of the NAP1 Strain at a Cancer Hospital
Clostridium difficile is the most common cause of health care-associated diarrhea. Accurate and rapid diagnosis is essential to improve patient outcome and prevent disease spread. We compared our two-step diagnostic algorithm, an enzyme immunoassay for glutamate dehydrogenase (GDH) followed by the c...
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Published in: | Journal of Clinical Microbiology 2010-12, Vol.48 (12), p.4519-4524 |
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creator | Babady, N. Esther Stiles, Jeffrey Ruggiero, Phyllis Khosa, Perminder Huang, David Shuptar, Susan Kamboj, Mini Kiehn, Timothy E |
description | Clostridium difficile is the most common cause of health care-associated diarrhea. Accurate and rapid diagnosis is essential to improve patient outcome and prevent disease spread. We compared our two-step diagnostic algorithm, an enzyme immunoassay for glutamate dehydrogenase (GDH) followed by the cytotoxin neutralization test (CYT) with a turnaround time of 24 to 48 h, versus the Cepheid Xpert C. difficile Epi assay, a PCR-based assay with a turnaround time of 90%). The excellent sensitivity and specificity and the rapid turnaround time of the Xpert PCR assay as well as its strain-typing capability make it an attractive option for diagnosis of C. difficile infection. |
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Esther ; Stiles, Jeffrey ; Ruggiero, Phyllis ; Khosa, Perminder ; Huang, David ; Shuptar, Susan ; Kamboj, Mini ; Kiehn, Timothy E</creator><creatorcontrib>Babady, N. Esther ; Stiles, Jeffrey ; Ruggiero, Phyllis ; Khosa, Perminder ; Huang, David ; Shuptar, Susan ; Kamboj, Mini ; Kiehn, Timothy E</creatorcontrib><description>Clostridium difficile is the most common cause of health care-associated diarrhea. Accurate and rapid diagnosis is essential to improve patient outcome and prevent disease spread. We compared our two-step diagnostic algorithm, an enzyme immunoassay for glutamate dehydrogenase (GDH) followed by the cytotoxin neutralization test (CYT) with a turnaround time of 24 to 48 h, versus the Cepheid Xpert C. difficile Epi assay, a PCR-based assay with a turnaround time of <1 h. In the first phase of the study, only GDH-positive stool samples were tested by both CYT and Xpert PCR. Discordant results were resolved by toxigenic culture. In the second phase, all stool samples were tested by GDH and Xpert PCR. Only GDH-positive stools were further tested by CYT. Genotypic characterization of 45 Xpert PCR-positive stools was performed by sequencing of the tcdC gene and PCR ribotyping. In phase 1, the agreement between the GDH-CYT and the GDH-Xpert PCR was 72%. The sensitivities and specificities of GDH-CYT and GDH-Xpert PCR were 57% and 97% and 100% and 97%, respectively. In phase 2, the agreement between GDH-CYT and Xpert PCR alone was 95%. As in phase 1, sensitivity of the Xpert PCR was higher than that of the GDH-CYT. The correlation between PCR-ribotyping, sequencing, and Xpert PCR for detection of NAP1 strains was excellent (>90%). The excellent sensitivity and specificity and the rapid turnaround time of the Xpert PCR assay as well as its strain-typing capability make it an attractive option for diagnosis of C. difficile infection.</description><identifier>ISSN: 0095-1137</identifier><identifier>EISSN: 1098-660X</identifier><identifier>DOI: 10.1128/JCM.01648-10</identifier><identifier>PMID: 20943860</identifier><identifier>CODEN: JCMIDW</identifier><language>eng</language><publisher>Washington, DC: American Society for Microbiology</publisher><subject>Bacterial Proteins - genetics ; Bacteriological Techniques - methods ; Bacteriology ; Biological and medical sciences ; Cancer Care Facilities ; Clostridium difficile ; Clostridium difficile - classification ; Clostridium difficile - isolation & purification ; Clostridium Infections - diagnosis ; Clostridium Infections - microbiology ; Cross Infection - diagnosis ; Cross Infection - microbiology ; Enzyme-Linked Immunosorbent Assay - methods ; Feces - microbiology ; Fundamental and applied biological sciences. Psychology ; Genotype ; Humans ; Medical sciences ; Microbiology ; Miscellaneous ; Polymerase Chain Reaction - methods ; Repressor Proteins - genetics ; Ribotyping ; Sensitivity and Specificity ; Tumors</subject><ispartof>Journal of Clinical Microbiology, 2010-12, Vol.48 (12), p.4519-4524</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright © 2010, American Society for Microbiology 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c496t-ae8ef520fd70d4761a95b9f53125a9afbbda32d2092a2de1b0e2e2467b3cda773</citedby><cites>FETCH-LOGICAL-c496t-ae8ef520fd70d4761a95b9f53125a9afbbda32d2092a2de1b0e2e2467b3cda773</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/PMC3008447/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3008447/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,3186,3187,27923,27924,53790,53792</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23597539$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20943860$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Babady, N. Esther</creatorcontrib><creatorcontrib>Stiles, Jeffrey</creatorcontrib><creatorcontrib>Ruggiero, Phyllis</creatorcontrib><creatorcontrib>Khosa, Perminder</creatorcontrib><creatorcontrib>Huang, David</creatorcontrib><creatorcontrib>Shuptar, Susan</creatorcontrib><creatorcontrib>Kamboj, Mini</creatorcontrib><creatorcontrib>Kiehn, Timothy E</creatorcontrib><title>Evaluation of the Cepheid Xpert Clostridium difficile Epi Assay for Diagnosis of Clostridium difficile Infection and Typing of the NAP1 Strain at a Cancer Hospital</title><title>Journal of Clinical Microbiology</title><addtitle>J Clin Microbiol</addtitle><description>Clostridium difficile is the most common cause of health care-associated diarrhea. Accurate and rapid diagnosis is essential to improve patient outcome and prevent disease spread. We compared our two-step diagnostic algorithm, an enzyme immunoassay for glutamate dehydrogenase (GDH) followed by the cytotoxin neutralization test (CYT) with a turnaround time of 24 to 48 h, versus the Cepheid Xpert C. difficile Epi assay, a PCR-based assay with a turnaround time of <1 h. In the first phase of the study, only GDH-positive stool samples were tested by both CYT and Xpert PCR. Discordant results were resolved by toxigenic culture. In the second phase, all stool samples were tested by GDH and Xpert PCR. Only GDH-positive stools were further tested by CYT. Genotypic characterization of 45 Xpert PCR-positive stools was performed by sequencing of the tcdC gene and PCR ribotyping. In phase 1, the agreement between the GDH-CYT and the GDH-Xpert PCR was 72%. The sensitivities and specificities of GDH-CYT and GDH-Xpert PCR were 57% and 97% and 100% and 97%, respectively. In phase 2, the agreement between GDH-CYT and Xpert PCR alone was 95%. As in phase 1, sensitivity of the Xpert PCR was higher than that of the GDH-CYT. The correlation between PCR-ribotyping, sequencing, and Xpert PCR for detection of NAP1 strains was excellent (>90%). 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Psychology</subject><subject>Genotype</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Polymerase Chain Reaction - methods</subject><subject>Repressor Proteins - genetics</subject><subject>Ribotyping</subject><subject>Sensitivity and Specificity</subject><subject>Tumors</subject><issn>0095-1137</issn><issn>1098-660X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNptkUtv1DAUhSMEotPCjjVYSIgNKX7k5Q3SKB1oUXlIbaXurJvYTlwlcbCTovk9_FGczrSAxMqS7-dzzvWJohcEHxNCi_efyy_HmGRJERP8KFoRzIs4y_D142iFMU9jQlh-EB16f4MxSZI0fRodUMwTVmR4Ff3a3EI3w2TsgKxGU6tQqcZWGYmuR-UmVHbWT85IM_dIGq1NbTqFNqNBa-9hi7R16MRAM1hv_CLx_wdng1b1nQsMEl1uRzM094Zf198JupgcmDCdEKAShlo5dGr9aCbonkVPNHRePd-fR9HVx81leRqff_t0Vq7P4zrh2RSDKpROKdYyxzLJMwI8rbhOGaEpcNBVJYFRGXanQKUiFVZU0STLK1ZLyHN2FH3Y6Y5z1StZqyFk6sToTA9uKywY8e9kMK1o7K1gGBdJsgi83Qs4-2NWfhK98bXqOhiUnb0ochqyZBkP5LsdWTvrvVP6wYVgsdQqQq3irtZwE_CXfyd7gO97DMCbPQC-hk678IPG_-FYyvOULb6vd1xrmvancUqA78VN3YvFiIokJQv0agdpsAIaF4SuLigmDBNOcpxT9htGacIs</recordid><startdate>20101201</startdate><enddate>20101201</enddate><creator>Babady, N. 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Esther</creatorcontrib><creatorcontrib>Stiles, Jeffrey</creatorcontrib><creatorcontrib>Ruggiero, Phyllis</creatorcontrib><creatorcontrib>Khosa, Perminder</creatorcontrib><creatorcontrib>Huang, David</creatorcontrib><creatorcontrib>Shuptar, Susan</creatorcontrib><creatorcontrib>Kamboj, Mini</creatorcontrib><creatorcontrib>Kiehn, Timothy E</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Environmental Sciences and Pollution Management</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of Clinical Microbiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Babady, N. Esther</au><au>Stiles, Jeffrey</au><au>Ruggiero, Phyllis</au><au>Khosa, Perminder</au><au>Huang, David</au><au>Shuptar, Susan</au><au>Kamboj, Mini</au><au>Kiehn, Timothy E</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the Cepheid Xpert Clostridium difficile Epi Assay for Diagnosis of Clostridium difficile Infection and Typing of the NAP1 Strain at a Cancer Hospital</atitle><jtitle>Journal of Clinical Microbiology</jtitle><addtitle>J Clin Microbiol</addtitle><date>2010-12-01</date><risdate>2010</risdate><volume>48</volume><issue>12</issue><spage>4519</spage><epage>4524</epage><pages>4519-4524</pages><issn>0095-1137</issn><eissn>1098-660X</eissn><coden>JCMIDW</coden><abstract>Clostridium difficile is the most common cause of health care-associated diarrhea. Accurate and rapid diagnosis is essential to improve patient outcome and prevent disease spread. We compared our two-step diagnostic algorithm, an enzyme immunoassay for glutamate dehydrogenase (GDH) followed by the cytotoxin neutralization test (CYT) with a turnaround time of 24 to 48 h, versus the Cepheid Xpert C. difficile Epi assay, a PCR-based assay with a turnaround time of <1 h. In the first phase of the study, only GDH-positive stool samples were tested by both CYT and Xpert PCR. Discordant results were resolved by toxigenic culture. In the second phase, all stool samples were tested by GDH and Xpert PCR. Only GDH-positive stools were further tested by CYT. Genotypic characterization of 45 Xpert PCR-positive stools was performed by sequencing of the tcdC gene and PCR ribotyping. In phase 1, the agreement between the GDH-CYT and the GDH-Xpert PCR was 72%. The sensitivities and specificities of GDH-CYT and GDH-Xpert PCR were 57% and 97% and 100% and 97%, respectively. In phase 2, the agreement between GDH-CYT and Xpert PCR alone was 95%. As in phase 1, sensitivity of the Xpert PCR was higher than that of the GDH-CYT. The correlation between PCR-ribotyping, sequencing, and Xpert PCR for detection of NAP1 strains was excellent (>90%). The excellent sensitivity and specificity and the rapid turnaround time of the Xpert PCR assay as well as its strain-typing capability make it an attractive option for diagnosis of C. difficile infection.</abstract><cop>Washington, DC</cop><pub>American Society for Microbiology</pub><pmid>20943860</pmid><doi>10.1128/JCM.01648-10</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Bacterial Proteins - genetics Bacteriological Techniques - methods Bacteriology Biological and medical sciences Cancer Care Facilities Clostridium difficile Clostridium difficile - classification Clostridium difficile - isolation & purification Clostridium Infections - diagnosis Clostridium Infections - microbiology Cross Infection - diagnosis Cross Infection - microbiology Enzyme-Linked Immunosorbent Assay - methods Feces - microbiology Fundamental and applied biological sciences. Psychology Genotype Humans Medical sciences Microbiology Miscellaneous Polymerase Chain Reaction - methods Repressor Proteins - genetics Ribotyping Sensitivity and Specificity Tumors |
title | Evaluation of the Cepheid Xpert Clostridium difficile Epi Assay for Diagnosis of Clostridium difficile Infection and Typing of the NAP1 Strain at a Cancer Hospital |
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