Background: Pathogenic Clostridium difficile produces two proinflammatory exotoxins, toxin A and toxin B. Low level of serum antitoxin IgG antibodies is a risk factor for the development of primary and recurrent C. difficile infection (CDI).
Results: We developed and validated two sensitive, titer-based electrochemiluminescence assays for the detection of serum antibody levels against C. difficile toxins A and B. These assays demonstrated excellent precision. The sensitivity of the assays allowed the detection of antitoxin A and antitoxin B IgG antibodies in all tested serum samples during assay validation.
Conclusion: The validated titer-based assays enable assessment of antitoxin A and antitoxin B IgG antibodies as potential biomarkers to identify patients with CDI at increased risk for CDI recurrence.
Keywords: Clostridium difficile; Clostridium difficile infection; Clostridium difficile recurrence; anti-C. difficile toxin A antibody; anti-C. difficile toxin B antibody; antibody titer assay; assay validation; biomarker; clinical biomarker assay; endogenous antitoxin antibody.