1990. Reactivity and Specificity of a Research Use Only (RUO) Prototype of a Highly Multiplexed Sample-to-Answer PCR System for the Detection of Pathogens from Positive Blood Culture
Session: Poster Abstract Session: Diagnostics: Bacteria and Mycobacteria
Saturday, October 6, 2018
Room: S Poster Hall
  • Reactivity and Specificity of RUO Protoype.pdf (1.5 MB)
  • Background: Rapid diagnosis of causative agents of bloodstream infections improves patient outcomes and antibiotic stewardship. BioFire Diagnostics, LLC, is developing the BioFire® Blood Culture Identification 2 (BCID2) Panel, increasing the coverage of the BioFire® FilmArray® Blood Culture Identification (BCID) Panel for key pathogens and antimicrobial resistance (AMR) markers in aerobic and anaerobic positive blood culture (PBC). This revision expands the menu from 27 to 42 targets, with 26 bacterial (14 revised, 6 new) and 7 fungal analytes (2 revised, 3 new), as well as 9 AMR markers (1 revised, 6 new). Notable additions include the anaerobe Bacteroides fragilis, the emerging fungus Candida auris, and the mobile colistin resistance gene, mcr-1. This study details the reactivity and specificity of a RUO BioFire BCID2 panel.

    Methods: The prototype was tested with fungal and bacterial isolates, some carrying AMR markers, at two sites by multiple operators. Reactivity was assessed at 106 CFU/mL for 301 analytes, and specificity at 108 CFU/mL for 43 on-panel and 93 off-panel strains. Evaluation included multiple strains for species level and AMR marker assays, as well as multiple species for family/genus level assays. Concordance with standard of care (SoC) results was examined for 126 archived PBC.

    Results: Testing against 136 on-panel organisms, phylogenetic-neighbors, and normal cutaneous flora, showed 100% specificity for 41/42 targets. Reactivity was confirmed for 346/351 target analytes, and comprehensive detection was observed for the revised family-level Enteric assay (90/90) and genus-level Staphylococcus spp. (51/51), Streptococcus spp. (17/17), and Candida spp. (67/71) assays. The prototype showed excellent sensitivity (97.1%) and specificity (99.7%) compared to SoC with archived PBC.

    Conclusion: Performance of this RUO BioFire BCID2 Panel indicates that many key pathogens implicated in bloodstream infections can be identified with high sensitivity and specificity, and highlights the utility of the expanded menu to provide actionable information. Future panel versions will address observed deficiencies.

    RUO products used in this study have not been evaluated by the FDA or other regulatory agencies for In Vitro Diagnostic use.

    Jeremiah Antosch, BS1, Usha Spaulding, MS1, Jessica Stone, BS1, Cameron Later, M.S.1, Kerrin Koch, BS1, Iryna Kavetska, B.S.1, Han Ton, B.S.1, Christine Alberti-Segui, Ph.D.2, Anne Grange, B.S.2, Caroline Dubost, B.S.2 and Margarita Rogatcheva, PhD1, (1)BioFire Diagnostics, LLC, Salt Lake City, UT, (2)bioMérieux, Inc., Grenoble, France


    J. Antosch, BioFire Diagnostics, LLC: Employee , Salary .

    U. Spaulding, BioFire Diagnostics, LLC: Employee , Salary .

    J. Stone, BioFire Diagnostics, LLC: Employee , Salary .

    C. Later, BioFire Diagnostics, LLC: Employee , Salary .

    K. Koch, BioFire Diagnostics, LLC: Employee , Salary .

    I. Kavetska, BioFire Diagnostics, LLC: Employee , Salary .

    H. Ton, BioFire Diagnostics, LLC: Employee , Salary .

    C. Alberti-Segui, bioMérieux: Employee , Salary .

    A. Grange, bioMereiux, Inc.: Employee , Salary .

    C. Dubost, bioMérieux: Employee , Salary .

    M. Rogatcheva, BioFire: Employee , Salary .

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 3rd with the exception of research findings presented at the IDWeek press conferences.