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Browsing by Author "Wolk, Donna M."
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Item Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment(Elsevier, 2022) Shihabuddin, Bashar S.; Faron, Matthew L.; Relich, Ryan F.; Van Heukelom, Paul; Mayne, Donna; Staat, Mary Allen; Selvarangan, Rangaraj; Hueschen, Leslie A.; Wolk, Donna M.; House, Stacey; Harnett, Glenn; McGann, Kevin; Steele, Mark T.; Romero, Jose R.; Arms, Joe; Lander, Owen; Loeffelholz, Michael; Strouts, Fiona; Cohen, Daniel; Pathology and Laboratory Medicine, School of MedicineThe COVID-19 pandemic highlighted the significance of readily available and easily performed viral testing for surveillance during future infectious pandemics. The objectives of this study were: to assess the performance of the Xpert Xpress Flu and/or RSV test, a multiplex PCR assay for detecting influenza A and B virus and respiratory syncytial virus nucleic acids in respiratory tract specimens, relative to the Quidel Lyra Influenza A+B assay and the Prodesse ProFlu+ assay, and the system's ease of use by minimally trained operators. Overall, the Xpert Xpress Flu/RSV test demonstrated a high positive and negative percent agreement with the comparator assays, and was easy to use and interpret results, based on the operators' feedback. We concluded that the Xpert Xpress Flu/RSV test is sensitive, specific, and easy to use for the diagnosis of influenza and RSV by minimally trained operators and can be a valuable tool in future infectious clusters or pandemics.Item Multicenter evaluation of the BIOFIRE Joint Infection Panel for the detection of bacteria, yeast, and AMR genes in synovial fluid samples(American Society for Microbiology, 2023) Esteban, Jaime; Salar-Vidal, Llanos; Schmitt, Bryan H.; Waggoner, Amy; Laurent, Frédéric; Abad, Lelia; Bauer, Thomas W.; Mazariegos, Irving; Balada-Llasat, Joan-Miquel; Horn, Jared; Wolk, Donna M.; Jefferis, Alexa; Hermans, Mirjam; Verhoofstad, Irma; Butler-Wu, Susan M.; Umali-Wilcox, Minette; Murphy, Caitlin; Cabrera, Barbara; Craft, David; von Bredow, Benjamin; Leber, Amy; Everhart, Kathy; Dien Bard, Jennifer; Flores, Irvin Ibarra; Daly, Judy; Barr, Rebecca; Holmberg, Kristen; Graue, Corrin; Kensinger, Bart; Medicine, School of MedicineThe 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.