Multicenter evaluation of the BIOFIRE Joint Infection Panel for the detection of bacteria, yeast, and AMR genes in synovial fluid samples.

Autor:	Esteban J; IIS-Fundacion Jimenez Diaz, CIBERINFEC-CIBER de Enfermedades Infecciosas , Madrid, Spain., Salar-Vidal L; IIS-Fundacion Jimenez Diaz, CIBERINFEC-CIBER de Enfermedades Infecciosas , Madrid, Spain., Schmitt BH; Indiana University School of Medicine , Indianapolis, Indiana, USA., Waggoner A; Indiana University School of Medicine , Indianapolis, Indiana, USA., Laurent F; Hospices Civils de Lyon , Lyon, France., Abad L; Hospices Civils de Lyon , Lyon, France., Bauer TW; Hospital for Special Surgery , New York, USA., Mazariegos I; Hospital for Special Surgery , New York, USA., Balada-Llasat J-M; The Ohio State University Wexner Medical Center , Columbus, Ohio, USA., Horn J; The Ohio State University Wexner Medical Center , Columbus, Ohio, USA., Wolk DM; Geisinger Health , Danville, Pennsylvania, USA., Jefferis A; Geisinger Health , Danville, Pennsylvania, USA., Hermans M; Jeroen Bosch Hospital , Den Bosch, the Netherlands., Verhoofstad I; Jeroen Bosch Hospital , Den Bosch, the Netherlands., Butler-Wu SM; University of Southern California , Los Angeles, California, USA., Umali-Wilcox M; University of Southern California , Los Angeles, California, USA., Murphy C; University of Nebraska Medical Center Omaha , Omaha, Nebraska, USA., Cabrera B; University of Nebraska Medical Center Omaha , Omaha, Nebraska, USA., Craft D; The Milton S. Hershey Medical Center , Hershey, Pennsylvania, USA., von Bredow B; The Milton S. Hershey Medical Center , Hershey, Pennsylvania, USA., Leber A; Nationwide Children's Hospital , Columbus, Ohio, USA., Everhart K; Nationwide Children's Hospital , Columbus, Ohio, USA., Dien Bard J; Children's Hospital Los Angeles , Los Angeles, California, USA., Flores II; Children's Hospital Los Angeles , Los Angeles, California, USA., Daly J; Primary Children's Hospital , Salt Lake City, Utah, USA., Barr R; Primary Children's Hospital , Salt Lake City, Utah, USA., Holmberg K; bioMérieux, Inc. , Salt Lake City, Utah, USA., Graue C; bioMérieux, Inc. , Salt Lake City, Utah, USA., Kensinger B; bioMérieux, Inc. , Salt Lake City, Utah, USA.
Jazyk:	angličtina
Zdroj:	Journal of clinical microbiology [J Clin Microbiol] 2023 Nov 21; Vol. 61 (11), pp. e0035723. Date of Electronic Publication: 2023 Oct 25.
DOI:	10.1128/jcm.00357-23
Abstrakt:	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. Competing Interests: J.E. has received research funding from bioMérieux and has served as a consultant for bioMérieux. AL has received research funding from BioFire, Cepheid, and Luminex. J.M.B.L. has served as a consultant for bioMérieux and has also participated in other BioFire clinical studies. B.S. has received research funding from BioFire, Becton, Dickinson and Company, and DiaSorin.
Databáze:	MEDLINE
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