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Clinical evaluation of a non-purified direct molecular assay for the detection of Clostridioides difficile toxin genes in stool specimens
- Source :
- PLoS ONE, PLoS ONE, Vol 15, Iss 6, p e0234119 (2020)
- Publication Year :
- 2020
- Publisher :
- Public Library of Science, 2020.
-
Abstract
- Recently, a new rapid assay for the detection of tcdB gene of Clostridioides difficile was developed using the GENECUBE. The assay can directly detect the tcdB gene from stool samples without a purification in approximately 35 minutes with a few minutes of preparation process. We performed a prospective comparative study of the performance of the assay at eight institutions in Japan. Fresh residual stool samples (Bristol stool scale ≥5) were used and comparisons were performed with the BD MAX Cdiff assay and toxigenic cultures. For the evaluation of 383 stool samples compared with the BD MAX Cdiff assay, the sensitivity, and specificity of the two assays was 99.0% (379/383), 98.1% (52/53), 99.1% (327/330), respectively. In the comparison with toxigenic culture, the total, sensitivity, and specificity were 96.6% (370/383), 85.0% (51/60), and 98.8% (319/323), respectively. The current investigation indicated the GENECUBE Clostridioides difficile assay has equivalent performance with the BD MAX Cdiff assay for the detection of tcdB gene of C. difficile.
- Subjects :
- 0301 basic medicine
Nosocomial Infections
Gene Identification and Analysis
Artificial Gene Amplification and Extension
medicine.disease_cause
Toxicology
Pathology and Laboratory Medicine
Polymerase Chain Reaction
Mass Spectrometry
law.invention
Analytical Chemistry
Enterotoxins
Feces
0302 clinical medicine
Bristol stool scale
Spectrum Analysis Techniques
law
Medicine and Health Sciences
Toxins
030212 general & internal medicine
Polymerase chain reaction
Multidisciplinary
Matrix-Assisted Laser Desorption Ionization Mass Spectrometry
Clostridium difficile
Chemistry
Infectious Diseases
Physical Sciences
Medicine
Anaerobic bacteria
Clinical evaluation
Research Article
Diarrhea
DNA, Bacterial
Clostridium Difficile
Science
030106 microbiology
Toxic Agents
Bacterial Toxins
Gastroenterology and Hepatology
Anaerobic Bacteria
Research and Analysis Methods
Sensitivity and Specificity
03 medical and health sciences
Signs and Symptoms
Bacterial Proteins
Diagnostic Medicine
parasitic diseases
medicine
Genetics
Humans
Molecular Biology Techniques
Gene
Molecular Biology
Mutation Detection
Bacteria
Toxin
business.industry
Clostridioides difficile
Gut Bacteria
Organisms
Biology and Life Sciences
Molecular biology
Repressor Proteins
Clostridium Infections
Reagent Kits, Diagnostic
business
Clostridioides
Subjects
Details
- Language :
- English
- ISSN :
- 19326203
- Volume :
- 15
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- PLoS ONE
- Accession number :
- edsair.doi.dedup.....f2da195bd45164ec26822f60079a4afd