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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. Disclosures Benjamin von Bredow, PhD, BioFire (Grant/Research Support) Jennifer Dien Bard, PhD, BioFire Diagnostic (Consultant, Scientific Research Study Investigator) Bart Kensinger, PhD, BioFire Diagnostics (Employee) Benedicte Pons, PhD, bioMerieux SA (Employee) Corinne Jay, PhD, bioMerieux SA (Employee)

Background Bone and Joint Infections (BJI) have high morbidity and are difficult to treat infections. Culture-based diagnosis is limited in its ability to recover fastidious bacteria and because several organisms can be involved; culture times of up to two weeks may be necessary for certain bacteria. The sensitivity of culture is also negatively impacted by antibiotics received before surgery. Alternatively, molecular methods offer a promising improvement for the diagnosis of BJI. The goal of this study was to evaluate a development version of Biofire® Bone and Joint Infection (BJI) Panel (bioMerieux SA, BioFire Diagnostics, LLC) using synovial fluid samples. Methods 121 synovial fluid specimens were collected from patients with suspected bone and joint infection in a pilot evaluation. All specimens were collected and tested in culture by the sites using their standard of care practices; in parallel, a leftover volume of 200 µL was tested on the BJI panel. BJI panel results were then compared with culture and discordant results were investigated using a comparator assay (PCR/sequencing). Results 49 synovial fluid specimens (40%) were positive by culture vs. 72 with the BJI panel (59%). Of the 97 positive detections by the BJI panel, 58 were concordant with culture; the 39 additional organism detections were in majority confirmed by PCR/sequencing. Lastly, two false negative results corresponding to the same sample are under investigation. Conclusion The BJI Panel was able to identify most of the pathogens detected by culture. The majority of additional detections observed were confirmed by PCR/sequencing. While sites are currently enrolling more synovial fluids samples, these preliminary data suggest that a multiplexed molecular test may be more sensitive than culture to detect pathogens in synovial fluid specimens. The data presented in this abstract have not been reviewed by FDA or other regulatory agencies for In Vitro Diagnostic use. Disclosures B. Pons, bioMerieux: Employee, Salary. C. Jay, bioMerieux: Employee, Salary. T. Martin, bioMerieux: Employee, Salary. I. Sothier, bioMerieux: Employee, Salary. H. Savelli, bioMerieux: Employee, Salary. B. Kensinger, bioFire a bioMerieux company: Employee, Salary. F. Laurent, BioFire (bioMerieux company): Investigator, Research support. L. Abad, BioFire (bioMerieux company): Investigator, Research support. C. Murphy, BioFire (bioMerieux company): Investigator, Research support. A. Craney, BioFire (bioMerieux company): Investigator, Research support. B. Schmitt, BioFire (bioMerieux company): Investigator, Research support. A. Waggoner, BioFire (bioMerieux company): Investigator, Research support. S. Butler-Wu, BioFire (bioMerieux): Investigator, Research support. C. Costales, BioFire (bioMerieux company): Investigator, Research support. J. Bien-Bard, BioFire (bioMerieux): Investigator, Research support. J. Mestas, BioFire (bioMerieux): Investigator, Research support. J. Esteban, BioFire (bioMerieux): Investigator, Research support. L. Salar-Vidal, BioFire (BioMerieux company)): Investigator, Research support. A. Harrington, BioFire (bioMerieux company): Investigator, Research support. S. Collier, BioFire (BioMerieux Company): Investigator, Research support. A. Leber, BioFire (bioMerieux company): Investigator, Research support. K. Everhart, BioFire (bioMerieux company): Investigator, Research support. J. M. Balada-Llasat, BioFire (bioMerieux company): Investigator, Research support. J. Horn, BioFire (bioMerieux company): Investigator, Research support. S. Magro, bioMerieux: Employee, Salary. K. Bourzac, BioFire a bioMerieux company: Employee, Salary.