640. Development of a Laboratory Verification Protocol for Concurrent Detection of Bacterial, Fungal, and Antimicrobial Resistance Genes in a Multiplex Syndromic Joint Infection Panel

Abstract

Abstract Background Verification is a critical component of implementing a diagnostic test in a clinical lab and can be time consuming and costly. A verification protocol and organism panel were developed in collaboration with ZeptoMetrix®, LLC to verify all analyte detections for the BioFire® Joint Infection (JI) Panel*. The BioFire JI Panel detects 31 pathogens and 8 antimicrobial resistance (AMR) genes associated with joint infections from synovial fluid specimens. Methods A protocol was developed using prototype NATtrol™ controls from ZeptoMetrix®, synovial fluid, and the BioFire® FilmArray® 2.0 and the BioFire® FilmArray® Torch Systems. Control materials were tested in the presence of synovial fluid from pooled human donors. The 32 targets required for all analyte detections were divided into 5 pools of 6-7 analytes and then tested over multiple days on several systems. Results Preliminary outcomes were good with a cumulative positive detection rate of 100% (310/310) and expected negative detections of 99.3% (1182/1190) from 50 prototype BioFire JI Panel test runs. AMRs were correctly identified in 50/50 (100%) replicates when a correlated bacterium was present. Unexpected detections of Streptococcus spp. (7/50) and Staphylococcus lugdunensis (1/50) were likely due to contaminants in the synovial fluid; Streptococcus spp. was confirmed by testing the synovial fluid in isolation. Conclusion Efficient performance verification may be achieved by combining 32 organisms/8 AMR into 5 pools and can be completed with 20 test runs in 4 days. The pooling scheme provides multiple positive/negative detections per analyte and accurately detects AMR. The protocol and controls serve as a useful tool for providing reliable detections of targets over multiple days, operators and systems and offers a flexible solution for supporting verification needs. *The BioFire® Joint Infection Panel is currently pending US FDA De Novo review. This product has not been evaluated by other global regulatory agencies for in vitro diagnostic use. Not available for sale. Panel menu subject to change. Disclosures Monica Cronin, MS, BioFire Diagnostics, LLC (Employee) Taylor K. Fadgen, Bachelor of Science, BioFire Diagnostics, LLC (Employee) Lisa Ogden, BS, BioFire Diagnostics, LLC (Employee) Jeremy P. Green, BS, BioFire Diagnostics, LLC (Employee, Shareholder) Stephanie A. Thatcher, MS, BioFire Diagnostics (Employee) Rebecca C. Young, MS, BioFire Diagnostics, LLC (Employee) Brandon Hoelcle, BS, ZeptoMetrix, LLC (Employee)