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Journal of Clinical Microbiology
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Bacteriology

Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End User Setting

Leslie J. Donato, Nikki K. Myhre, Martha A. Murray, Margaret R. McDonah, Jane F. Myers, Julie A. Maxson, Alicia M. Meek, Mark J. Espy, Joseph W. Furst, Brad S. Karon, Matthew J. Binnicker
Paul Bourbeau, Editor
Leslie J. Donato
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA
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Nikki K. Myhre
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA
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Martha A. Murray
Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA
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Margaret R. McDonah
Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA
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Jane F. Myers
Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA
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Julie A. Maxson
Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA
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Alicia M. Meek
Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA
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Mark J. Espy
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA
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Joseph W. Furst
Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA
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Brad S. Karon
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA
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Matthew J. Binnicker
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA
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Paul Bourbeau
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DOI: 10.1128/JCM.01629-18
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ABSTRACT

Although U.S. Food and Drug Administration-approved and CLIA-waived point-of-care (POC) molecular systems are being implemented in routine clinical practice, instrument reliability, test performance in the hands of end users, and the potential for environmental contamination resulting from use of POC molecular systems have not been extensively evaluated. We performed a prospective evaluation of the Roche cobas Liat group A streptococcus (GAS) assay compared to routine real-time PCR. We evaluated test accuracy, instrument failure rate, and monitored for environmental contamination when testing was performed by minimally trained end users in an Express Care Clinic environment. The overall concordance of the Liat GAS assay with routine testing was 97.2% (455/468). The average Liat failure rate across three analyzers was 6.6% (33/501) (range, 3.7 to 11.6%), and no environmental contamination was detected during the course of the study. The cobas Liat platform and GAS assay demonstrated reliable performance in the end user setting and may serve as a rapid, POC option for routine diagnostic testing for certain infectious diseases, including GAS.

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Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End User Setting
Leslie J. Donato, Nikki K. Myhre, Martha A. Murray, Margaret R. McDonah, Jane F. Myers, Julie A. Maxson, Alicia M. Meek, Mark J. Espy, Joseph W. Furst, Brad S. Karon, Matthew J. Binnicker
Journal of Clinical Microbiology Jan 2019, 57 (2) e01629-18; DOI: 10.1128/JCM.01629-18

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Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End User Setting
Leslie J. Donato, Nikki K. Myhre, Martha A. Murray, Margaret R. McDonah, Jane F. Myers, Julie A. Maxson, Alicia M. Meek, Mark J. Espy, Joseph W. Furst, Brad S. Karon, Matthew J. Binnicker
Journal of Clinical Microbiology Jan 2019, 57 (2) e01629-18; DOI: 10.1128/JCM.01629-18
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KEYWORDS

group A Streptococcus
Liat
point of care

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