Zhao Xuemei, Bender Florent, Shukla Rajiv, Kang John J, Caro-Aguilar Ivette, Laterza Omar F
Translational Molecular Biomarkers, Merck Research Laboratories, Rahway, NJ 07065, USA.
Drug Metabolism & Pharmacokinetics, Novartis Institutes for Biomedical Research, Basel 4057, Switzerland.
Bioanalysis. 2016 Apr;8(7):611-23. doi: 10.4155/bio-2015-0033. Epub 2016 Mar 11.
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).
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.
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.
致病性艰难梭菌产生两种促炎性外毒素,即毒素A和毒素B。血清抗毒素IgG抗体水平低是原发性和复发性艰难梭菌感染(CDI)发生的一个危险因素。
我们开发并验证了两种基于滴度的灵敏电化学发光测定法,用于检测血清中针对艰难梭菌毒素A和B的抗体水平。这些测定法显示出极佳的精密度。在测定法验证期间,这些测定法的灵敏度能够检测所有测试血清样本中的抗毒素A和抗毒素B IgG抗体。
经过验证的基于滴度的测定法能够评估抗毒素A和抗毒素B IgG抗体,作为潜在生物标志物以识别有CDI复发高风险的CDI患者。