title: Clinical comparison of Simplexa universal direct and BD GeneOhm tests for detection of toxigenic Clostridium difficile in stool samples.
abstract: We compared the performance characteristics of the Simplexa universal direct (Focus Diagnostics, Cypress, CA) and BD GeneOhm (BD Diagnostics/GeneOhm Sciences, San Diego, CA) tests for detection of toxigenic Clostridium difficile in 459 stool samples (9.4% positive). The observed agreement for the results of the two tests with 452 samples with valid test results was 98.2% (kappa, 0.9; P value of 0.73 by the McNemar test). When samples with discordant or invalid results were retested, the agreement increased to 100%.
authors.affiliation: Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: Frederick S
authors.initials: FS
authors.lastname: Nolte
authors.forename: Danielle G
authors.initials: DG
authors.lastname: Ribeiro-Nesbitt
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods*; D002648:Child; D002675:Child, Preschool; 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*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D055815:Young Adult