238. Comparative Evaluation of Diatherix TEM-PCR And BioFire FilmArray® in the Detection of Viral And Bacterial Respiratory Pathogens
Session: Poster Abstract Session: Diagnostics: Virology
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • 238_IDWPOSTER.pdf (170.5 kB)
  • Background: The speed and efficiency of etiologic determination of influenza-like illness (ILI) has been greatly improved with multiplex diagnostic assays. We conducted a comparative evaluation of two multiplex assays with coverage of viral and bacterial respiratory pathogens.

    Methods: Specimens (n=403) were derived from an observational study of febrile ILI among otherwise healthy subjects at five US military hospitals from 2009-2014. Specimens were first tested by single-plex PCR for influenza. Specimens were then tested by two assays: [1] target‐enriched multiplex PCR (TEM-PCR; Diatherix Laboratories, Inc.; Huntsville, AL) and [2] BioFire FilmArray® Respiratory Panel (FilmArray; BioFire Diagnostics, Salt Lake City, UT). The panels have eight viral (human Rhinovirus / Enterovirus (HRV/EV), Influenza A, Influenza B, Coronavirus, RSV, parainfluenza, human metapneumovirus (hMPV), adenovirus (ADV)) and three bacterial (Mycoplasma pneumoniae, Bordetella pertussis and Chlamydophila pneumoniae) pathogens in common. Specimens were selected based on availability, and tests were performed in separate laboratories. Kappa (κ) coefficients and 95% confidence intervals (CI) were computed.

    Results: The multiplex evaluation of influenza-PCR-positive specimens (n=34) was incomplete and thus excluded from analysis. Of the 308 specimens with complete results, TEM-PCR and FilmArray® detected at least one viral pathogen among 197 (64.0%) and 198 (64.3%) specimens, respectively. The frequency of viral co-detection (i.e. two or more viral pathogens in a specimen) was 7.1% for TEM-PCR and 6.5% for BioFire FilmArray® (p=0.67; McNemar’s test). Only one (0.3%) specimen was positive for C. pneumoniae by FilmArray®, and neither assay detected B. pertussis. Pathogen-specific agreement between the panels was as follows: HRV/EV (κ=0.75, 95%CI: 0.66, 0.84), Coronavirus (κ=0.91, 95%CI: 0.86, 0.97), RSV (κ=0.85, 95%CI: 0.77, 0.94), parainfluenza (κ=0.97, 95%CI: 0.91, 1), hMPV (κ=0.85, 95%CI: 0.74, 0.96), ADV (κ=0.21, 95%CI: -0.15, 0.58), and M. pneumoniae (κ=0.72, 95%CI: 0.42, 1).

    Conclusion: These results reveal a high degree of concordance between Diatherix Laboratories TEM-PCR and BioFire FilmArray® in the detection of viral respiratory pathogens.

    Wei-Ju Chen, PhD1, John Arnold, MD2, Mary Fairchok, MD1,3, Erin Hansen, BS4, Leslie Malone, MS, MB(ASCP)CM5, Elena Grigorenko, PhD5, Donald Stalons, PhD, D(ABMM), MPH5, Jacqueline Owens Milzman, M.S.1, Michelande Ridore, MS1,6, Christian Coles, PhD1, Timothy Burgess, MD1 and Eugene Millar, PhD1, (1)Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, (2)Naval Medical Center San Diego, San Diego, CA, (3)Madigan Army Medical Center, Tacoma, WA, (4)Naval Health Research Center, San Diego, CA, (5)Diatherix Laboratories, LLC, Huntsville, AL, (6)Children's National Medical Center, Washington, DC

    Disclosures:

    W. J. Chen, None

    J. Arnold, None

    M. Fairchok, None

    E. Hansen, None

    L. Malone, Diatherix Laboratories, LLC: Employee , Salary

    E. Grigorenko, Diatherix Laboratories, LLC: Employee , Salary

    D. Stalons, Diatherix Laboratories, LLC: Employee , Salary

    J. Owens Milzman, None

    M. Ridore, None

    C. Coles, None

    T. Burgess, None

    E. Millar, None

    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.