WebJul 1, 2024 · FDA-Approved Multiplex PCR Assay—Spinal Fluid BioFire FilmArray ME Panel. The BioFire FilmArray ME panel is a U.S. Food and Drug Administration approved and cleared multiplex PCR test that detects DNA or RNA of 15 pathogens, including 7 viruses, 6 bacteria, and 1 yeast from spinal fluid. Specifically, the assay detects … WebWith fast and accurate diagnosis of important pathogens, the BIOFIRE ® FILMARRAY ® GI Panel provides clinicians with the information necessary to make the best treatment decisions for improved patient outcomes and decreased healthcare costs . Simple: 2 minutes of hands-on time. Easy: No precise measuring or pipetting required.
April 29, 2024 - Food and Drug Administration
WebThe BIOFIRE JI Panel tests for a comprehensive grouping of gram-positive and gram-negative bacteria, yeast, and antimicrobial resistance genes commonly associated with joint infections. It takes just one syndromic test, one small sample of synovial fluid, and about an hour to get results on 39 clinically relevant targets. WebBioFire ® Joint Infection Panel 1 Test. 39 Targets. ~1 Hour. Newly cleared under an FDA De Novo authorization, the BioFire JI Panel offers an improved diagnostic approach to … curious george baby clothes
INTERNAL USE ONLY - BioFire Diagnostics
WebJournal of Bone and Joint Infection (Jan 2024) ... The BIOFIRE JI Panel showed a high specificity (100 %, 95 % confidence interval (CI): 78–100) in all patient categories. Sensitivity was 83 % (95 % CI: 44–97) for patients with a clinical suspicion of native septic arthritis (n=12), 73 % (95 % CI: 48–89) for patients with a clinical ... WebSimple, comprehensive respiratory testing. The BIOFIRE ® Respiratory 2.1 plus Panel tests for 19 viruses and 4 bacteria which cause respiratory tract infections with an overall performance: 97.1% sensitivity and 99.3% specificity, SARS-CoV-2 Performance: 98.4% PAA, 98.9% NPA.It works on the BIOFIRE ® FILMARRAY ® 2.0 and Torch systems, an … WebThe 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 … curious george a very monkey christmas album