Molecular Test Based on Isothermal Helicase-Dependent Amplification for Detection of the Clostridium difficile Toxin A Gene

ABSTRACT The AmpliVue Clostridium difficile assay and a glutamate dehydrogenase (GDH)-illumigene algorithm were evaluated using 308 diarrheal stool specimens of patients suspected of having C. difficile infection. Compared to the enriched toxigenic culture method, the sensitivities, specificities, and positive and negative predictive values of the AmpliVue C. difficile assay and the GDH-illumigene-based algorithm were 91.7% (95% confidence interval [CI], 76.4 to 97.8), 100% (95% CI, 98.3 to 100), 100% (95% CI, 87 to 100), and 98.9% (95% CI, 96.6 to 99.7), respectively.

[1]  S. Gorbach,et al.  Neutralization of Clostridium difficile toxin by Clostridium sordellii antitoxins , 1978, Infection and immunity.

[2]  R. Humphries,et al.  Comparison of Illumigene, Simplexa, and AmpliVue Clostridium difficile Molecular Assays for Diagnosis of C. difficile Infection , 2013, Journal of Clinical Microbiology.

[3]  M. Wilcox,et al.  Reference assays for Clostridium difficile infection: one or two gold standards? , 2010, Journal of Clinical Pathology.

[4]  G. Hobbs,et al.  Diagnosis of Clostridium difficile-associated disease: examination of multiple algorithms using toxin EIA, glutamate dehydrogenase EIA and loop-mediated isothermal amplification , 2012, British journal of biomedical science.

[5]  D. Crook,et al.  Differences in outcome according to Clostridium difficile testing method: a prospective multicentre diagnostic validation study of C difficile infection , 2013, Lancet. Infectious Diseases (Print).

[6]  O. Dekkers,et al.  European Society of Clinical Microbiology and Infectious Diseases (ESCMID): data review and recommendations for diagnosing Clostridium difficile-infection (CDI). , 2009, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases.

[7]  J. O’Horo,et al.  Molecular techniques for diagnosis of Clostridium difficile infection: systematic review and meta-analysis. , 2012, Mayo Clinic proceedings.

[8]  N. Shetty,et al.  The role of glutamate dehydrogenase for the detection of Clostridium difficile in faecal samples: a meta-analysis. , 2011, The Journal of hospital infection.

[9]  B. Coignard,et al.  Clinical and microbiological features of Clostridium difficile infections in France: the ICD-RAISIN 2009 national survey. , 2013, Medecine et maladies infectieuses.

[10]  N. Dendukuri,et al.  Comparison of eight commercial enzyme immunoassays for the detection of Clostridium difficile from stool samples and effect of strain type. , 2012, Diagnostic microbiology and infectious disease.

[11]  K. Manickam,et al.  Evaluation of an Algorithmic Approach in Comparison with the Illumigene Assay for Laboratory Diagnosis of Clostridium difficile Infection , 2013, Journal of Clinical Microbiology.

[12]  D. Gerding,et al.  Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) , 2010, Infection Control & Hospital Epidemiology.

[13]  F. Barbut,et al.  Clinical Features of Clostridium difficile–Associated Infections and Molecular Characterization of Strains: Results of a Retrospective Study, 2000-2004 , 2007, Infection Control & Hospital Epidemiology.

[14]  M. Rupnik,et al.  Clostridium difficile toxinotype XI (A-B-) exhibits unique arrangement of PaLoc and its upstream region. , 2010, Anaerobe.

[15]  E. Nagy,et al.  Laboratory diagnosis of Clostridium difficile infections: there is light at the end of the colon. , 2013, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[16]  C. Eckert,et al.  New molecular methods for the diagnosis of Clostridium difficile infections. , 2012, Drugs of today.

[17]  C. Surawicz,et al.  C. difficile Infection: Changing Epidemiology and Management Paradigms , 2015, Clinical and Translational Gastroenterology.

[18]  W. Stamm,et al.  Nosocomial acquisition of Clostridium difficile infection. , 1989, The New England journal of medicine.

[19]  C. Eckert,et al.  Evaluation of a Loop-Mediated Isothermal Amplification Assay for Diagnosis of Clostridium difficile Infections , 2011, Journal of Clinical Microbiology.

[20]  T. Riley,et al.  Novel Molecular Type of Clostridium difficile in Neonatal Pigs, Western Australia , 2013, Emerging infectious diseases.