A multicenter evaluation of a sample to answer real-time PCR assay for toxigenic C. difficile in symptomatic subjects

• Published in: Diagnostic microbiology and infectious disease Vol. 96; no. 1; p. 114920
• Main Authors: Pancholi, Preeti, Young, Steve, Widen, R., Silbert, Suzane, Schmitt, B., Dunn, R., Drain, A., Weissfeld, S.A.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2020
• Subjects: Adolescent; Adult; Bacterial Proteins - genetics; Bacterial Toxins - genetics; C. difficile; C. difficile infection; Child; Child, Preschool; Clostridium difficile - isolation & purification; Clostridium Infections - diagnosis; Clostridium Infections - microbiology; Feces - microbiology; Female; Humans; Infant; Luminex ARIES; Male; Middle Aged; Molecular Diagnostic Techniques; NAAT; PCR; Prospective Studies; Real-Time Polymerase Chain Reaction; Sensitivity and Specificity; Young Adult; PPA; NAAT; C. difficile; C. difficile infection; Luminex ARIES; CDI; CCNA; EIA; NPA; PCR
• ISSN: 0732-8893; 1879-0070; 1879-0070
• DOI: 10.1016/j.diagmicrobio.2019.114920

We evaluated the performance of the Luminex ARIES® C. difficile Assay on 984 stool specimens prospectively collected from patients being tested for CDI at 4 clinical laboratories in the United States. Results were compared to direct and enriched toxigenic culture. Positive percent agreement (PPA) of the ARIES® C. difficile Assay was 98.1% versus direct toxigenic culture, and sensitivity versus direct plus enriched toxigenic culture was 90.5%. Negative percent agreement (NPA) of the ARIES® C. difficile Assay against direct culture was 92.6%, and specificity versus direct plus enriched toxigenic culture was 95.8%. The ARIES® C. difficile Assay was also compared to the results of routine (molecular, antigen, and/or toxin) methods for C. difficile testing used at each institution. The PPA of the ARIES® C. difficile Assay ranged from 82.9% to 100%. NPA values against these commercial assays ranged from 94.5% to 100%.