649. Rapid and Accurate PCR Diagnosis of Influenza and RSV with the cobas Liat System in Point of Care Settings
Session: Poster Abstract Session: Oh, Those Pesky Viruses!
Thursday, October 27, 2016
Room: Poster Hall
  • IDWeek2016FluRSVFinalPoster.pdf (384.5 kB)
  • Background: Point-of-care testing for influenza and respiratory syncytial virus (RSV) needs to be both rapid and accurate in order to guide effective patient management and infection control. While rapid antigen-based tests are sometimes used, they demonstrate sensitivity as low as 50-70%. The cobas® Influenza A/B and RSV assay is an easy-to-use automated PCR test performed on the cobas® Liat System for detection of influenza A, influenza B, and RSV from nasopharyngeal (NP) swabs in approximately 20 minutes. No reagent preparation, sample manipulation, or formal laboratory training is required. We evaluated the performance of the test in CLIA-waived point of care settings.

    Methods:  NP swabs were prospectively collected from 1361 patients with influenza-like illnesses presenting to 8 Primary Care Clinics and 4 Emergency Departments during the 2013-2014 and 2014-2015 flu seasons. Testing for Influenza A/B and RSV on the cobas® Liat platform was conducted by 38 CLIA-waived intended use operators, primarily nurses and medical assistants, with no formal laboratory training. An additional 300 retrospectively collected NP swabs were also tested. Influenza A/B and RSV assay results were compared to a conventional laboratory PCR test. Rapid antigen test results, if used by sites as part of routine clinical care, were also analyzed.

    Results:  The cobas® Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for influenza A, influenza B, and RSV, respectively, when compared to laboratory based PCR testing. Specificity was 97.5%, 99.7%, and 98.8% for influenza A, influenza B, and RSV, respectively. Rapid antigen testing was performed for influenza (796 patients) and RSV (187 patients) as part of routine care by several sites and only demonstrated sensitivities of 79.7%, 80.0%, and 87.1% for influenza A, influenza B, and RSV, respectively.

    Conclusion: The cobas® Influenza A/B and RSV assay was highly sensitive and specific. The availiability of an accurate, rapid, and easy to use point of care test with laboratory quality PCR results can improve treatment decisions, patient management, and surveillance efforts for influenza and RSV.

    Kemi Williams, MBA1, Yu Tian, PhD2, Jane Gibson, PhD3, Sharon Mace, MD4, Patricia Mitchell, RN5, Elissa Schechter-Perkins, MD, MPH5, Belinda Yen-Lieberman, Ph.D.6, Robert Luo, MD, MPH1 and Lingjun Chen, BA2, (1)Roche Molecular Systems, Pleasanton, CA, (2)Roche Molecular Systems, Marlborough, MA, (3)University of Central Florida, Orlando, FL, (4)Cleveland Clinic, Cleveland, OH, (5)Emergency Medicine, Boston University, Boston, MA, (6)Laboratory Medicine, Cleveland Clinic, Cleveland, OH


    K. Williams, Roche: Employee , Salary

    Y. Tian, Roche: Employee , Salary

    J. Gibson, None

    S. Mace, None

    P. Mitchell, None

    E. Schechter-Perkins, None

    B. Yen-Lieberman, None

    R. Luo, Roche: Employee , Salary

    L. Chen, Roche: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.