BIOFIRE Joint Infection Panel Detects 39 Targets in Synovial Fluid in About One Hour
A multicenter evaluation of the BIOFIRE Joint Infection Panel tested 1,544 prospective synovial fluid samples for 31 organisms and several antimicrobial resistance genes. The panel achieved sensitivity of 90.9% or greater for most organisms and specificity above 98.5% for all targets, with 100% positive percent agreement for all AMR genes. With results available in approximately one hour versus days for standard culture, this panel addresses a critical diagnostic gap in prosthetic and native joint infections.
The original study
Multicenter evaluation of the BIOFIRE Joint Infection Panel for the detection of bacteria, yeast, and AMR genes in synovial fluid samples.
- Authors
- Esteban J, Salar-Vidal L, Schmitt BH, Waggoner A, Laurent F, Abad L, et al.
- Journal
- Journal of clinical microbiology
- Type
- Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't
- PMID
- 37877730
Original abstract
The bioMérieux BIOFIRE Joint Infection (JI) Panel is a multiplex in vitro diagnostic test for the simultaneous and rapid (~1 h) detection of 39 potential pathogens and antimicrobial resistance (AMR) genes directly from synovial fluid (SF) samples. Thirty-one species or groups of microorganisms are included in the kit, as well as several AMR genes. This study, performed to evaluate the BIOFIRE JI Panel for regulatory clearance, provides data from a multicenter evaluation of 1,544 prospectively collected residual SF samples with performance compared to standard-of-care (SOC) culture for organisms or polymerase chain reaction (PCR) and sequencing for AMR genes. The BIOFIRE JI Panel demonstrated a sensitivity of 90.9% or greater for all but six organisms and a positive percent agreement (PPA) of 100% for all AMR genes. The BIOFIRE JI Panel demonstrated a specificity of 98.5% or greater for detection of all organisms and a negative percent agreement (NPA) of 95.7% or greater for all AMR genes. The BIOFIRE JI Panel provides an improvement over SOC culture, with a substantially shorter time to result for both organisms and AMR genes with excellent sensitivity/PPA and specificity/NPA, and is anticipated to provide timely and actionable diagnostic information for joint infections in a variety of clinical scenarios.