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Bloodstream infections: fast diagnosis using molecular tools

Multi-center Evaluation of the BIOFIRE® FILMARRAY® Blood Culture Identification 2 Panel for the Detection of Microorganisms and Resistance Markers in Positive Blood Cultures

April 18 • P0186

K. Holmberg1, Y. Lu1, S. Vourli1, S. Pournaras2, K. Everhart3, A. Leber3, B. Barr4, J. Daly4, T. Henry5, A. Johnson5, JM. Balada-Llasat5, D. Rhoads6, M. Jacobs6, K. McKinley7, A. Harrington7, F. Zhang8, G. Berry8, M. Jeong9, R. She9, M. Fantini10, G. Dirani10, S. Zannoli10, V. Sambri10/11, U. Spaulding1, K. Bourzac1

1) BioFire Diagnostics, LLC, Salt Lake City, UT, USA
2) Athens Medical School/Attikon University Hospital, Clinical Microbiology Laboratory, Athens, Greece
3) Nationwide Children's Hospital, Columbus, OH, USA
4) Primary Children's Hospital, Salt Lake City, UT, USA
5) The Ohio State University Wexner Medical Center, Columbus, OH, USA
6) University Hospitals Cleveland Medical Center, OH, USA
7) Loyola University Medical Center, IL, USA
8) Northwell Health Labs, NY, USA
9) University of Southern California, CA, USA
10) Unit of Microbiology, The Romagna Hub Laboratory, Pievesestina, Cesena, Italy
11) University of Bologna, Bologna, Italy

Background: The BIOFIRE® FILMARRAY® Blood Culture Identification 2 (BCID2) Panel is a rapid diagnostic test that provides results for 26 bacterial analytes, seven fungal analytes, and ten antimicrobial resistance (AMR) genes from positive blood culture (PBC) specimens in about an hour. The BCID2 Panel builds upon the existing BCID Panel with several additional assays that include Bacteroides fragilis, Candida auris, and additional AMR genes (CTX-M, IMP, mcr-1, mecA/C and MREJ, NDM, OXA-48-like, and VIM). Here, we summarize studies conducted to establish clinical performance using an Investigational Use Only version of the BCID2 Panel.

Materials/methods: A total of 1074 residual PBCs were enrolled at 7 US and 2 EU sites between October 2018 and May 2019. BCID2 Panel performance was compared to routine standard of care microbial culture, as well as molecular methods for AMR genes. In addition, BCID2 Panel MRSA results were compared to the FDA-cleared Xpert® MRSA/SA BC test (Cepheid, Inc).

Results: The BCID2 Panel identified at least one organism in 90.9% of enrolled PBCs. Among the 12.8% of positive specimens with multiple organism detections by the BCID2 Panel, combinations of gram-positive (GP) bacteria mixed with gram-negative (GN) bacteria, GP with yeast, GN with yeast, and combinations of all three were observed. The BCID2 Panel demonstrated an overall sensitivity of 99.2% and specificity of 99.6% for the identification of microorganisms compared to culture. Concordance between the BCID2 Panel and the Xpert MRSA/SA BC test for the identification of MRSA was 91.2% positive percent agreement (PPA) and 97.9% negative percent agreement (NPA); however, 100% concordance was observed when compared to phenotypic MRSA characterization by the laboratory. The overall PPA and NPA for the remainder of the BCID2 Panel AMR genes as compared to molecular methods was 98.9% and 99.9%, respectively. The overall success rate of obtaining valid results in initial specimen tests was 99.7%.

Conclusions: The new BCID2 Panel is a sensitive, specific, and robust test for rapid detection of microorganisms (including mixed polymicrobial samples) and a variety of AMR genes in PBCs.

Data presented are from assays that have not been cleared or approved for diagnostic use.


BCID2 Panel

Paper poster