Faculty Collaboration Database

Multicenter evaluation of the Quidel Lyra Direct C. difficile nucleic acid amplification assay. J Clin Microbiol 2014 Jun;52(6):1998-2002

Date

03/29/2014

Pubmed ID

24671790

Pubmed Central ID

PMC4042815

DOI

10.1128/JCM.03089-13

Scopus ID

2-s2.0-84901650235 (requires institutional sign-in at Scopus site)   15 Citations

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.

Author List

Beck ET, Buchan BW, Riebe KM, Alkins BR, Pancholi P, Granato PA, Ledeboer NA

Authors

Blake W. Buchan PhD Professor in the Pathology department at Medical College of Wisconsin
Nathan A. Ledeboer PhD Vice Chair, Professor in the Pathology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Bacterial Toxins
Clostridium Infections
Diarrhea
Feces
Humans
Molecular Diagnostic Techniques
Neutralization Tests
Nucleic Acid Amplification Techniques
Prospective Studies
Sensitivity and Specificity
United States