Molecular test based on isothermal helicase-dependent amplification for detection of the Clostridium difficile toxin A gene.
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.
Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, National Reference Laboratory for C. difficile, Paris, France UPMC, Universite Paris 06, GRC-2, Epidiff, Paris, France catherine.eckert@sat.aphp.fr.
Catherine
C
Eckert
Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, National Reference Laboratory for C. difficile, Paris, France.
Eleonore
E
Holscher
Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, National Reference Laboratory for C. difficile, Paris, France UPMC, Universite Paris 06, GRC-2, Epidiff, Paris, France.
Amandine
A
Petit
Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, National Reference Laboratory for C. difficile, Paris, France Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, Microbiology Unit, Paris, France UPMC, Universite Paris 06, GRC-2, Epidiff, Paris, France.
Valérie
V
Lalande
Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, National Reference Laboratory for C. difficile, Paris, France Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, Microbiology Unit, Paris, France UPMC, Universite Paris 06, GRC-2, Epidiff, Paris, France.
Frédéric
F
Barbut
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001427:Bacterial Toxins / Q000235:genetics*; D002648:Child; D002675:Child, Preschool; D016360:Clostridioides difficile / Q000235:genetics* / Q000302:isolation & purification*; D003015:Clostridium Infections / Q000175:diagnosis / Q000382:microbiology; D003967:Diarrhea / Q000175:diagnosis / Q000382:microbiology; D004768:Enterotoxins / Q000235:genetics*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D055815:Young Adult
D001427:Bacterial Toxins; D004768:Enterotoxins; C041348:tcdA protein, Clostridium difficile