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Evaluation of the illumigene C. difficile assay for toxigenic Clostridium difficile detection: a prospective study of 302 consecutive clinical fecal samples.
- Source :
-
Diagnostic Microbiology & Infectious Disease . Nov2014, Vol. 80 Issue 3, p177-180. 4p. - Publication Year :
- 2014
-
Abstract
- Toxigenic Clostridium difficile is a major pathogen causing nosocomial diarrhea. Consequently, rapid detection of toxigenic C. difficile is very important in clinical laboratories. The illumigene C. difficile DNA amplification assay (illumigene; Meridian Bioscience, Inc.) is a rapid method that detects the toxin A gene ( tcdA ) by loop-mediated isothermal amplification. In the present study, we evaluated the diagnostic performance of the illumigene assay using 302 consecutive stool specimens in comparison with the VIDAS C. difficile A&B enzyme-linked fluorescent immunoassay (VIDAS-CDAB; bioMérieux). Toxigenic culture was used as the reference method. The sensitivity, specificity, positive predictive value, and negative predictive value of the illumigene assay were 88.1%, 96.7%, 86.7%, and 97.1%, respectively, while those of the VIDAS-CDAB assay were 40.4%, 98.8%, 87.5%, and 88.5%, respectively. It is of note that use of a combination of the illumigene and VIDAS-CDAB assays did not improve any of the 4 evaluated parameters (88.1%, 95.5%, 82.5%, and 97.1%, respectively). The illumigene assay showed limits of detection of 250 and 11,467 CFU/mL for ATCC 9688 ( tcdA +, tcdB +, cdtB −) and ATCC 43598 ( tcdA −, tcdB +, cdtB −) reference strains, respectively, and there was no cross-reactivity with 8 frequently isolated bacterial species. In conclusion, the illumigene assay might be a useful method for rapid detection of toxigenic C. difficile in clinical laboratories. Additionally, the VIDAS-CDAB assay seems unnecessary if the illumigene assay is used. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 07328893
- Volume :
- 80
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- Diagnostic Microbiology & Infectious Disease
- Publication Type :
- Academic Journal
- Accession number :
- 99066892
- Full Text :
- https://doi.org/10.1016/j.diagmicrobio.2014.08.014