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.
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