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The BioFire Joint Infection (JI) Panel is a multiplexed nucleic-acid-based, in vitro diagnostic test intended for use with BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. The following organisms are identified using the BioFire JI Panel: Anaerococcus prevotii/vaginalis, Bacteroides fragilis, Candida spp., Candida albicans, Citrobacter, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterobacter cloacae complex, Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Fingoldia magna, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii. Neisseria gonorrhoeae, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., Serratia marcescens, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes. The BioFire JI Panel contains assays for the detection of genetic determinants associated with S. aureus resistance to methicillin (mecA/C) in conjunction with the SCCmec right extremity junction (MREJ), enterococcal resistance to vancomycin (vanA and vanB), and some mechanisms of gram-negative bacterial resistance ß-lactams including penicillins, cephalosporins, monobactams, and carbapenems (blactx.M, blakec, blaNDM, blaOXA-48-like; blavin). Detection of these genetic determinants can aid in the identification of potentially antimicrobial-resistant organisms in synovial fluid samples. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, and ß-lactams exist. The BioFire JI Panel is indicated as an aid in the diagnosis of specific agents of joint infection and results should be used in conjunction with other clinical and laboratory findings. Negative results may be due to infection with pathogens that are not detected by this test, pathogens present below the limit of detection of the assay, or infection that may not be detected in a synovial fluid specimen. Positive results do not rule out co-infection with other organisms. The BioFire JI Panel is not intended to monitor treatment for joint infections. Culture of synovial fluid is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the synovial fluid that are not detected by the BioFire JI Panel, and to further identify species in the genus, complex or group results.

The BioFire Joint Infection (JI) Panel is designed to simultaneously identify 39 different bacteria, yeast, and select genetic determinants of antimicrobial resistance from synovial fluid specimens. The BioFire JI Panel is compatible with BioFire's PCR-based in vitro diagnostic BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems for infectious disease testing. A panel-specific software module (i.e., BioFire JI Panel pouch module software) is used to perform BioFire JI Panel testing on these systems. A test is initiated by loading Hydration Solution into one port of the BioFire JI Panel pouch and the synovial fluid sample mixed with the provided Sample Buffer into the other port of the BioFire JI Panel pouch and placing it in a FilmArray instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the BioFire Software guides the user through the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run. The FilmArray instrument contains a coordinated system of inflatable bladders and seal points. which act on the pouch to control the movement of liguid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically-controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis. Nucleic acid extraction occurs within the FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the Film Array performs a nested multiplex PCR that is executed in two stages. During the first stage, the FilmArray performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double stranded DNA binding dye (LC Green Plus, BioFire Diagnostics). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the end of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data. The FilmArray Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.