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Journal of Clinical Microbiology, March 2009, p. 758-764, Vol. 47, No. 3
0095-1137/09/$08.00+0     doi:10.1128/JCM.01714-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Multicenter Evaluation of the Cepheid Xpert Methicillin-Resistant Staphylococcus aureus (MRSA) Test as a Rapid Screening Method for Detection of MRSA in Nares{triangledown}

D. M. Wolk,1* E. Picton,1 D. Johnson,1 T. Davis,2 P. Pancholi,3 C. C. Ginocchio,4 S. Finegold,5 D. F. Welch,6,7 M. de Boer,1 D. Fuller,2 M. C. Solomon,3 B. Rogers,7 M. S. Mehta,8 and L. R. Peterson8

The University of Arizona/BIO5 Institute, Tucson, Arizona,1 Wishard Memorial Hospital, Indiana University Indianapolis, Indiana,2 The Ohio State University Medical Center, Columbus, Ohio,3 North Shore-Long Island Jewish Health System Laboratories, Lake Success, New York,4 VA Medical Center, West Los Angeles, California,5 Medical City Dallas Hospital,6 Children's Medical Center and University of Texas Southwestern Medical Center, Dallas, Texas,7 Evanston Northwestern Healthcare, Evanston, Illinois8

Received 4 September 2008/ Returned for modification 24 October 2008/ Accepted 25 December 2008

The first U.S. multicenter clinical trial to assess the performance of the Cepheid Xpert MRSA assay (Xpert MRSA) was conducted. The assay is a qualitative test designed for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) directly from nares swabs. This novel test combines integrated nucleic acid extraction and automated real-time PCR for the detection of a MRSA-specific signature sequence. A total of 1,077 nares specimens were collected from seven geographically distinct health care sites across the United States with prevalence rates ranging from 5.2% to 44%. Nares specimens were tested by (i) the Xpert MRSA assay, (ii) direct culture on CHROMagar MRSA medium (direct CM culture), and (iii) broth-enriched culture (Trypticase soy broth with 6.5% sodium chloride) followed by plating onto CHROMagar MRSA medium (broth-enriched CM culture). When direct CM culture was designated the reference method, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Xpert MRSA assay were 94.3%, 93.2%, 73.0%, and 98.8%, respectively. When broth-enriched CM culture was used as the reference method, the clinical sensitivity, specificity, PPV, and NPV of the Xpert MRSA assay were 86.3%, 94.9%, 80.5%, and 96.6%, respectively. The BD GeneOhm MRSA (BDGO) assay was performed as a comparative molecular method. No statistical performance differences were observed between the Xpert MRSA and BDGO assays when they were compared to culture methods. From this large-scale, multicenter clinical comparison, we conclude that the Xpert MRSA assay is a simple, rapid, and accurate method for performing active surveillance for MRSA in a variety of health care populations.

* Corresponding author. Mailing address: Microbiology, Molecular Diagnostics, University of Arizona, Pathology, BIO5 Institute, 1501 N. Campbell Avenue, P.O. Box 245059, Tucson, AZ 85724-5059. Phone: (520) 626-3676. Fax: (520) 694-7329. E-mail: dwolk{at}email.arizona.edu

{triangledown} Published ahead of print on 7 January 2009.

Journal of Clinical Microbiology, March 2009, p. 758-764, Vol. 47, No. 3
0095-1137/09/$08.00+0     doi:10.1128/JCM.01714-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.



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