Evaluation of a Gastrointestinal Pathogen Panel Immunoassay in Stool Testing of Patients with Suspected Clostridioides (Clostridium) difficile Infection

J Clin Microbiol. 2019 Sep 24;57(10):e00710-19. doi: 10.1128/JCM.00710-19. Print 2019 Oct.

Abstract

Clostridioides (Clostridium) difficile infection (CDI) is the most common causative pathogen of health care-associated gastrointestinal infections; however, due to the overlap of clinical symptoms with those of other causes of acute gastroenteritis, the selection of the most appropriate laboratory test is difficult. From April to October 2018, 640 stool samples requested for CDI testing were examined using the mariPOC CDI and Gastro test (ArcDia), which allows the detection of C. difficile glutamate dehydrogenase (GDH) and toxin A/B, norovirus genogroups GI and GII.4, rotavirus, adenovirus, and Campylobacter spp. In parallel, the C. Diff Quik Chek Complete test (Alere) was used as a routine diagnostic assay, and C. difficile toxigenic culture was used as a reference method. The sensitivity of the mariPOC CDI and Gastro test was comparable to that of C. Diff Quik Chek Complete for the detection of GDH (96.40% [95% confidence interval {CI}, 91.81% to 98.82%] versus 95.68% [95% CI, 90.84 to 98.40%]; P = 1.00) and was higher for the detection of toxin A/B (66.67% [95% CI, 57.36 to 75.11%] versus 55.56% [95% CI, 46.08 to 64.74%]; P = 0.00). The specificity of the mariPOC CDI and Gastro test was lower than that of C. Diff Quik Chek Complete for GDH detection (95.21% [95% CI, 92.96% to 96.91%] versus 97.60% [95% CI, 95.85% to 98.76%]; P = 0.04) and comparable to that of C. Diff Quik Chek Complete for toxin A/B detection (99.24 [95% CI, 98.05% to 99.79%] versus 99.81% [95% CI, 98.94% to 100.0%]; P = 0.37). In 29 cases (4.53%), other causative agents of diarrhea were detected (Campylobacter spp. [n = 17], rotavirus [n = 7], and norovirus genogroup GII.4 [n = 5]).

Keywords: Clostridium difficile; gastrointestinal infection; glutamate dehydrogenase; toxin A/B.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Bacterial Proteins / genetics
  • Bacterial Toxins / genetics
  • Child
  • Child, Preschool
  • Clostridioides difficile* / enzymology
  • Clostridioides difficile* / genetics
  • Clostridioides difficile* / immunology
  • Clostridium Infections / diagnosis*
  • Clostridium Infections / immunology
  • Clostridium Infections / microbiology*
  • Diagnostic Tests, Routine
  • Disease Management
  • Enterocolitis, Pseudomembranous / diagnosis
  • Enterocolitis, Pseudomembranous / immunology
  • Enterocolitis, Pseudomembranous / microbiology
  • Enterotoxins / genetics
  • Feces / microbiology*
  • Female
  • Glutamate Dehydrogenase
  • Humans
  • Immunoassay* / methods
  • Immunoassay* / standards
  • Infant
  • Male
  • Middle Aged
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Bacterial Proteins
  • Bacterial Toxins
  • Enterotoxins
  • tcdA protein, Clostridium difficile
  • toxB protein, Clostridium difficile
  • Glutamate Dehydrogenase