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

Authors

Preeti Pancholi, The Ohio State University Wexner Medical Center, Columbus, OH. Electronic address: Preeti.Pancholi@osumc.edu
Steve Young, Tricore Reference Laboratories, Albuquerque, NM; University of New Mexico, Albuquerque, NM
R Widen, Tampa General Hospital, Tampa, FL
Suzane Silbert, Tampa General Hospital, Tampa, FL
B Schmitt, Indiana University, Indianapolis, IN
R Dunn, Luminex Corporation, Austin, TX
A Drain, Luminex Corporation, Austin, TX
S A. Weissfeld, Microbiology Specialist, Inc., Houston, TX

Document Type

Article

Publication Date

1-1-2020

Abstract

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%.

Recommended Citation

Pancholi P, Young S, Widen R, Silbert S, Schmitt B, Dunn R, Drain A, Weissfeld SA. A multicenter evaluation of a sample to answer real-time PCR assay for toxigenic C. difficile in symptomatic subjects. Diagn Microbiol Infect Dis. 2020 Jan;96(1):114920. doi: 10.1016/j.diagmicrobio.2019.114920. Epub 2019 Oct 24. PMID: 31699545.