231. Rapid and accurate point-of-care PCR diagnosis of influenza A and B with the cobas® Liat system in CLIA-waived settings
Session: Poster Abstract Session: Diagnostics: Virology
Thursday, October 8, 2015
Room: Poster Hall
  • IDSA2015FluFINAL.pdf (378.2 kB)
  • Background: CLIA-waived settings allow non-laboratory trained staff to perform point-of-care diagnostic tests in places such as physician offices, emergency departments, and pharmacies. While rapid antigen-based tests are used, they can demonstrate low sensitivity.  The cobas® Influenza A/B assay is an easy-to-use, 20-minute, automated PCR test performed on the cobas® Liat System for detection of influenza A and B from nasopharyngeal (NP) swabs. We determined the performance of the assay in CLIA-waived settings using operators with no laboratory training.

    Methods: Prospective NP swabs were collected from patients with signs and symptoms of influenza in the US during the 2008-2009, 2013-2014 and 2014-2015 flu seasons. Retrospectively collected NP swabs were also tested, and rapid antigen-based testing was done as well. cobas® Influenza A/B assay and rapid antigen test results were compared to viral culture and/or an FDA-cleared laboratory PCR test. 

    Results: The performance of the cobas® Influenza A/B assay was evaluated by 33 non-laboratory trained operators at 12 CLIA-waived sites. In 784 prospective NP swabs, cobas® Influenza A/B assay sensitivity was 97.5% and 96.9% for influenza A and B, respectively, and specificity was 97.9% for both influenza A and B, when compared to viral culture. In comparison, rapid antigen tests demonstrated a sensitivity of 55.4% and 71.4% and specificity of 97.5% and 99.2% for influenza A and B, respectively. Compared to a lab-based FDA-cleared PCR test, the study demonstrated assay positive agreement of 97.7% and 98.6% for influenza A and B, respectively; and negative agreement of 99.2% and 99.4% for influenza A and B, respectively across 842 prospective specimens and 300 retrospective specimens.  In comparison, the study demonstrated rapid antigen test positive agreement of 54.4% and 62.2% and negative agreement of 97.8% and 99.5% for influenza A and B, respectively. 

    Conclusion: The high accuracy, rapid time to result and remarkable ease-of-use make the cobas® Influenza A/B assay a highly suitable point-of-care solution in CLIA-waived settings. No reagent preparation, sample manipulation, or other operator intervention is required. Such a solution can improve treatment decisions, patient management, and epidemiological surveillance efforts for influenza A and B.

    Yu Tian, PhD1, Alan Huang, PhD1, Kemi Williams, MBA2, Patrick Volkir, BS2, Robert Luo, MD, MPH2 and Lingjun Chen, BA1, (1)Roche Molecular Systems, Marlborough, MA, (2)Roche Molecular Systems, Pleasanton, CA


    Y. Tian, Roche Molecular Systems: Employee , Salary

    A. Huang, Roche Molecular Systems: Employee , Salary

    K. Williams, Roche Molecular Systems: Employee , Salary

    P. Volkir, Roche Molecular Systems: Employee , Salary

    R. Luo, Roche Molecular Systems: Employee , Salary

    L. Chen, Roche Molecular Systems: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.