title: Multicenter evaluation of the Quidel Lyra Direct C. difficile nucleic acid amplification assay.
abstract: Clostridium difficile is a Gram-positive bacterium commonly found in health care and long-term-care facilities and is the most common cause of antibiotic-associated diarrhea. Rapid detection of this bacterium can assist physicians in implementing contact precautions and appropriate antibiotic therapy in a timely manner. The purpose of this study was to compare the clinical performance of the Quidel Lyra Direct C. difficile assay (Lyra assay) (Quidel, San Diego, CA) to that of a direct cell culture cytotoxicity neutralization assay (CCNA) and enhanced toxigenic culture. This study was performed at three geographically diverse laboratories within the United States using residual stool specimens submitted for routine C. difficile testing. Residual samples were tested using the Lyra assay on three real-time PCR platforms, and results were compared to those for direct CCNA and enhanced toxigenic culture. The test results for all platforms were consistent across all three test sites. The sensitivity and specificity of the Lyra assay on the SmartCycler II, ABI 7500 Fast DX, and ABI QuantStudio DX instruments compared to CCNA were 90.0% and 93.3%, 95.0% and 94.2%, and 93.8% and 95.0%, respectively. Compared to enhanced toxigenic culture, the sensitivity and specificity of the Lyra assay on the SmartCycler II, ABI 7500, and QuantStudio instruments were 82.1% and 96.9%, 89.3% and 98.8%, and 85.7% and 99.0%, respectively. Overall, the Lyra assay is easy to use and versatile and compares well to C. difficile culture methods.
authors.affiliation: Department of Microbiology, Dynacare Laboratories, Milwaukee, Wisconsin, USA.
authors.forename: Eric T
authors.initials: ET
authors.lastname: Beck
authors.affiliation: Department of Microbiology, Dynacare Laboratories, Milwaukee, Wisconsin, USA Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
authors.forename: Blake W
authors.initials: BW
authors.lastname: Buchan
authors.affiliation: Department of Microbiology, Dynacare Laboratories, Milwaukee, Wisconsin, USA.
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Riebe
authors.affiliation: Department of Microbiology, Laboratory Alliance of Central New York, Liverpool, New York, USA.
authors.forename: Brenda R
authors.initials: BR
authors.lastname: Alkins
authors.affiliation: Department of Pathology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
authors.forename: Preeti
authors.initials: P
authors.lastname: Pancholi
authors.affiliation: Department of Microbiology, Laboratory Alliance of Central New York, Liverpool, New York, USA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Granato
authors.affiliation: Department of Microbiology, Dynacare Laboratories, Milwaukee, Wisconsin, USA Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA nledeboe@mcw.edu.
authors.forename: Nathan A
authors.initials: NA
authors.lastname: Ledeboer
mesh_terms: D001427:Bacterial Toxins / Q000032:analysis; D016360:Clostridioides difficile / Q000235:genetics / Q000302:isolation & purification*; D003015:Clostridium Infections / Q000175:diagnosis* / Q000382:microbiology; D003967:Diarrhea / Q000175:diagnosis* / Q000382:microbiology; D005243:Feces / Q000382:microbiology; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009500:Neutralization Tests / Q000379:methods; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014481:United States
chemical_list: D001427:Bacterial Toxins