Sensitive assays enable detection of serum IgG antibodies against Clostridium difficile toxin A and toxin B in healthy subjects and patients with Clostridium difficile infection

Author:

Zhao Xuemei1,Bender Florent12,Shukla Rajiv1,Kang John J3,Caro-Aguilar Ivette45,Laterza Omar F1

Affiliation:

1. Translational Molecular Biomarkers, Merck Research Laboratories, Rahway, NJ 07065, USA

2. Drug Metabolism & Pharmacokinetics, Novartis Institutes for Biomedical Research, Basel 4057, Switzerland

3. Biometrics Research, Merck Research Laboratories, Rahway, NJ 07065, USA

4. Vaccines Basic Research, Merck Research Laboratories, West Point, PA 19486, USA

5. Janssen Research & Development, L.L.C., 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA

Abstract

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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