Affiliated Laboratory, Inc., Bangor, ME 04401, USA.
Diagn Microbiol Infect Dis. 2010 Feb;66(2):129-34. doi: 10.1016/j.diagmicrobio.2009.09.001.
Enzyme immunoassays are currently the most common tests used in the clinical laboratory for the detection of Clostridium difficile toxins; however, significant problems with their performance have recently been described. We prospectively reevaluated the Meridian Premier C. difficile toxin A/B assay with direct comparison to a 2-step algorithm that screened for C. difficile common antigen and compared cytotoxin and real-time polymerase chain reaction (PCR) as confirmatory procedures. The Premier assay lacked sufficient sensitivity, missing 25% of true-positive samples. PCR was the most sensitive method and the only procedure that allowed same day testing and reporting.
酶免疫分析是目前临床实验室检测艰难梭菌毒素最常用的方法;然而，最近描述了其性能存在重大问题。我们前瞻性地重新评估了 Meridian Premier C. difficile 毒素 A/B 检测法，与两步法进行了直接比较，两步法筛选艰难梭菌共同抗原，并将细胞毒素和实时聚合酶链反应（PCR）作为确认程序进行了比较。Premier 检测法灵敏度不足，漏检了 25%的真阳性样本。PCR 是最敏感的方法，也是唯一能够在同一天进行检测和报告的方法。
