531. Clinical Evaluation of the BioFire® FilmArray® Gastrointestinal (GI) Panel for use with Rectal Swab Specimens in Cary-Blair Media
نویسندگان
چکیده
Abstract Background The BioFire® FilmArray® Gastrointestinal (GI) Panel provides results for 22 bacterial, viral, and protozoan pathogens responsible GI infection in about an hour. This test is indicated use with stool specimens Cary-Blair media (SCB) as a specimen type. For many patients, sample can be difficult to provide during single clinic visit, potentially delaying diagnosis treatment. Rectal swabs (RSCB; off-label type) are more convenient faster type collect, collection occur patient’s healthcare visit. purpose of this study was assess the performance when testing RSCB compared SCB. Methods Paired SCB were collected from outpatient subjects signs tested parallel using Panel. All detections confirmed culture (for some bacterial analytes) PCR/sequencing. Performance versus types assessed ratios (RSCB/SCB) sensitivities false positive rates (FPR). Positive percent agreement (PPA) negative (NPA) also evaluated. Results A total 299 paired Detections 17 analytes on observed both types. When comparing types, overall ratio sensitivity 0.86 FPR 0.31. Further, PPA 76.6% NPA 99.8%. Conclusion Overall, sensitive specific rapid detection organisms either type, however have lower diagnostic yield (i.e. fewer detections) As result, characterized less specimens. Acknowledging these limitations, convenience time-to-result benefits may aid effective management settings. BioFire FilmArray not cleared or approved rectal Cary-Blair. Disclosures Jared Goos, PhD, bioMerieux: Employee|bioMerieux: Stocks/Bonds Crissy Neff, n/a, Kristen Holmberg, Employee Annie Lyons, Nicole Monroe, Dr. sc. nat., Rangaraj Selvarangan, BVSc, D(ABMM), FIDSA, F(AAM), BioFire: Grant/Research Support|Luminex: Support Kimberle Chapin, MD, Cepheid: Bradley A. Connor, BioMerieux: Advisor/Consultant Cynthia Andjelic, Employee.
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ژورنال
عنوان ژورنال: Open Forum Infectious Diseases
سال: 2022
ISSN: ['2328-8957']
DOI: https://doi.org/10.1093/ofid/ofac492.586