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Bacteriology

Evaluation of a New Automated Homogeneous PCR Assay, GenomEra C. difficile, for Rapid Detection of Toxigenic Clostridium difficile in Fecal Specimens

Jari J. Hirvonen, Silja Mentula, Suvi-Sirkku Kaukoranta
Jari J. Hirvonen
aDepartment of Clinical Microbiology, Vaasa Central Hospital, Vaasa, Finland
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Silja Mentula
bDepartment of Infectious Disease Surveillance and Control, Bacteriology Unit, National Institute for Health and Welfare, Helsinki, Finland
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Suvi-Sirkku Kaukoranta
aDepartment of Clinical Microbiology, Vaasa Central Hospital, Vaasa, Finland
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DOI: 10.1128/JCM.01083-13
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ABSTRACT

We evaluated a new automated homogeneous PCR assay to detect toxigenic Clostridium difficile, the GenomEra C. difficile assay (Abacus Diagnostica, Finland), with 310 diarrheal stool specimens and with a collection of 33 known clostridial and nonclostridial isolates. Results were compared with toxigenic culture results, with discrepancies being resolved by the GeneXpert C. difficile PCR assay (Cepheid). Among the 80 toxigenic culture-positive or GeneXpert C. difficile assay-positive fecal specimens, 79 were also positive with the GenomEra C. difficile assay. Additionally, one specimen was positive with the GenomEra assay but negative with the confirmatory methods. Thus, the sensitivity and specificity were 98.8% and 99.6%, respectively. With the culture collection, no false-positive or -negative results were observed. The analytical sensitivity of the GenomEra C. difficile assay was approximately 5 CFU per PCR test. The short hands-on (<5 min for 1 to 4 samples) and total turnaround (<1 h) times, together with the high positive and negative predictive values (98.8% and 99.6%, respectively), make the GenomEra C. difficile assay an excellent option for toxigenic C. difficile detection in fecal specimens.

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Evaluation of a New Automated Homogeneous PCR Assay, GenomEra C. difficile, for Rapid Detection of Toxigenic Clostridium difficile in Fecal Specimens
Jari J. Hirvonen, Silja Mentula, Suvi-Sirkku Kaukoranta
Journal of Clinical Microbiology Aug 2013, 51 (9) 2908-2912; DOI: 10.1128/JCM.01083-13

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Evaluation of a New Automated Homogeneous PCR Assay, GenomEra C. difficile, for Rapid Detection of Toxigenic Clostridium difficile in Fecal Specimens
Jari J. Hirvonen, Silja Mentula, Suvi-Sirkku Kaukoranta
Journal of Clinical Microbiology Aug 2013, 51 (9) 2908-2912; DOI: 10.1128/JCM.01083-13
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