322 - Evaluation of the BioFire® Bone and Joint Infection (BJI) Panel for the Detection of Microorganisms and Antimicrobial Resistance Genes in Synovial Fluid Specimens

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Presenting Author(s)

CG

Corrin Graue

Clinical Data Specialist
BioFire Diagnostics
Salt Lake City, Utah
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Co-Author(s)

BS

Bryan H. Schmitt

Medical Director, Division of Clinical Microbiology
Department of Pathology and Laboratory Medicine, Indiana University School of Medicine
Indianapolis, Indiana
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
AW

Amy Waggoner

Clinical Research Coordinator
Indiana University School of Medicine
Indianapolis, Indiana
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
FL

Frederic Laurent

Professor
French National Reference Center for Staphylococci
Lyon, Rhone-Alpes, France
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
LA

Lelia Abad

Pharmacist resident
Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon)
Lyon, Rhone-Alpes, France
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
TB

Thomas Bauer

Pathologist-in-Chief & Director
Hospital for Special Surgery
New York, New York
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
IM

Irving Mazariegos

Microbiology Manager
Hospital for Special Surgery
New York, New York
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
JB

Joan-Miquel Balada-Llasat

Associate Director, Clinical Microbiology
The Ohio State University
Columbus, Ohio
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
JH

Jarid Horn

Clinical Research
The Ohio State University Wexner Medical Center
Columbus, Ohio
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
DW

Donna Wolk

Division Chief, Molecular and Microbial Diagnostics and Development
Geisinger Medical Center
Danville, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
AJ

Alexa Jefferis

Clinical Research
Geisinger Medical Center
Danville, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
MH

Mirjam Hermans

Principle Investigator
jeroen bosch ziekenhuis
's-Hertogenbosch, Noord-Brabant, Netherlands
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
IV

Irma Verhoofstad

Clinical Research
jeroen bosch ziekenhuis
Waalwijk, Noord-Brabant, Netherlands
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
SB

Susan Butler-Wu

Associate Professor of Clinical Pathology
Director of Medical Microbiology, LAC+USC Medical Center
Los Angeles, California
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
MU

Minette Umali-Wilcox

CLS II
Keck School of Medicine of USC
Los Angeles, California
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CM

Caitlin N. Murphy

University of Nebraska Medical Center
Omaha
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
BC

Barbara J. Cabrera

Research Assistant
University of Nebraska Medical Center
Omaha, Nebraska
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
JE

Jaime Esteban

Principle Investigator
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
AM

Alicia Macias-Valcayo

Clinical Research
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
DC

David Craft

Medical Director of Microbiology
Penn State Hershey Medical Center
Hershey, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Bv

Benjamin von Bredow

Postdoctoral Scholar
Penn State Hershey Medical Center
Hershey, Pennsylvania
Disclosure: BioFire (Grant/Research Support)
AL

Amy Leber

Director, Clinical Microbiology and Immunoserology
Nationwide Childrens Hospital
Columbus, Ohio
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
KE

Kathy Everhart

Lab Manager
Nationwide Children's Hospital
Columbus, OH
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Jennifer Dien Bard

Director, Clinical Microbiology and Virology; Professor of Pathology (Clinical Scholar)
Children's Hospital Los Angeles; University of Southern California
Los Angeles, CA
Disclosure: BioFire Diagnostic (Consultant, Scientific Research Study Investigator)
JM

Javier Mestas

Research Associate
Children’s Hospital Los Angeles
Los Angeles, California
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
JD

Judy Daly

Director-Microbiology Laboratories
Primary Children's Hospital
Salt Lake City, UT
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
RB

Rebecca Barr

Research Associate
Primary Children's Hospital
Salt Lake Citu, Utah
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
BK

Bart Kensinger

Clinical Research Scientist
BioFire Diagnostics
Salt Lake City, Utah
Disclosure: BioFire Diagnostics (Employee)
BP

Benedicte Pons

Staff Scientist
bioMerieux SA
Grenoble, Rhone-Alpes, France
Disclosure: bioMerieux SA (Employee)
CJ

Corinne Jay

Scientist
bioMerieux SA
Grenoble, Rhone-Alpes, France
Disclosure: bioMerieux SA (Employee)

Background: Bone and Joint Infections (BJIs) present with non-specific symptoms that may include pain, swelling, and fever and are associated with high morbidity and significant risk of mortality. BJIs can be caused by a variety of bacteria and fungi, including anaerobes and microorganisms that can be challenging to culture or identify by traditional microbiological methods. Clinicians primarily rely on culture to identify the pathogen(s) responsible for infection. The BioFire^® Bone and Joint Infection (BJI) Panel (BioFire Diagnostics, Salt Lake City, UT) is designed to detect 15 gram-positive bacteria (including seven anaerobes), 14 gram-negative bacteria (including one anaerobe), two yeast, and eight antimicrobial resistance (AMR) genes from synovial fluid specimens in about an hour. The objective of this study was to evaluate the performance of an Investigational Use Only (IUO) version of the BioFire BJI Panel compared to various reference methods.

Methods: Remnant synovial fluid specimens, which were collected for routine clinical care at 13 study sites in the US and Europe, underwent testing using an IUO version of the BioFire BJI Panel. Performance of this test was determined by comparison to Standard of Care (SoC) consisting of bacterial culture performed at each study site according to their routine procedures.

Results: A total of 1544 synovial fluid specimens were collected and tested with the BioFire BJI Panel. The majority of specimens were from knee joints (77.9%) and arthrocentesis (79.4%) was the most common collection method. Compared to SoC culture, overall sensitivity was 90.2% and specificity was 99.8%. The BioFire BJI Panel yielded a total of 268 Detected results, whereas SoC yielded a total of 215 positive results for on-panel analytes.

Conclusion: The BioFire BJI Panel is a sensitive, specific, and robust test for rapid detection of a wide range of analytes in synovial fluid specimens. The number of microorganisms and resistance genes included in the BioFire BJI Panel, together with a reduced time-to-result and increased diagnostic yield compared to culture, is expected to aid in the timely diagnosis and appropriate management of BJIs.