A multicenter evaluation of a sample to answer real-time PCR assay for toxigenic C. difficile in symptomatic subjects |
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| Institution: | 1. The Ohio State University Wexner Medical Center, Columbus, OH;2. Tricore Reference Laboratories, Albuquerque, NM;3. Tampa General Hospital, Tampa, FL;4. Indiana University, Indianapolis, IN;5. Luminex Corporation, Austin, TX;6. Microbiology Specialist, Inc., Houston, TX;7. University of New Mexico, Albuquerque, NM;1. Medical and Molecular Microbiology, Faculty of Science and Medicine, University of Fribourg, Fribourg, Switzerland;2. INSERM European Unit (IAME, France), University of Fribourg, Fribourg;3. Swiss National Reference Center for Emerging Antibiotic Resistance (NARA), University of Fribourg, Fribourg;4. Institute for Microbiology, University of Lausanne and University Hospital Centre, Lausanne, Switzerland;1. Pfizer Inc, Groton, CT, USA;2. School of Medicine, CEMIC University, Buenos Aires, Argentina;3. International Health Management Associates, Inc., Schaumburg, IL, USA;1. National Institute of Gastroenterology “S. de Bellis”, Research Hospital, Castellana Grotte, Italy;2. Virology Unit, Bambino Gesù Children''s Hospital, Rome, Italy;3. Department of Molecular Medicine, Sapienza University, Rome, Italy;1. Universidad Nacional de Asunción, Instituto de Investigaciones en Ciencias de la Salud, Departamento de Producción, Paraguay;2. Emory University, Department of Medicine, Division of Infectious Diseases, Atlanta, GA, USA;3. Universidad Nacional de Asunción, Instituto de Investigaciones en Ciencias de la Salud, Departamento de Salud Pública, Paraguay;4. Department of Pathology, University of Texas Medical Branch, Galveston, TX, USA;5. Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA;6. Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, , Stanford, CA, USA;7. Rollins School of Public Health, Department of Global Health, Atlanta, GA, USA;1. Specialty Internal Medicine and Quality Department, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia;2. Indiana University School of Medicine, Indianapolis, Indiana, USA;3. Johns Hopkins University School of Medicine, Baltimore, MD, USA;4. General Internal Medicine Unit, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia;1. Vaccine and Drug Evaluation Centre, Department of Community Health Sciences, University of Manitoba, 337-750 McDermot Avenue, Winnipeg, MB, R3E 0T5, Canada;2. Diagnostic Services, Shared Health, Clinical Microbiology, Saint-Boniface Hospital, L4025-409 Taché Avenue, Winnipeg, MB, R2H 2A6 |
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| Abstract: | We evaluated the performance of the Luminex ARIES® C. difficile Assay on 984 stool specimens prospectively collected from patients being tested for CDI at 4 clinical laboratories in the United States. Results were compared to direct and enriched toxigenic culture. Positive percent agreement (PPA) of the ARIES® C. difficile Assay was 98.1% versus direct toxigenic culture, and sensitivity versus direct plus enriched toxigenic culture was 90.5%. Negative percent agreement (NPA) of the ARIES® C. difficile Assay against direct culture was 92.6%, and specificity versus direct plus enriched toxigenic culture was 95.8%. The ARIES® C. difficile Assay was also compared to the results of routine (molecular, antigen, and/or toxin) methods for C. difficile testing used at each institution. The PPA of the ARIES® C. difficile Assay ranged from 82.9% to 100%. NPA values against these commercial assays ranged from 94.5% to 100%. |
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