Nucleic acid amplification tests for diagnosing Clostridioides difficile infections (CDI) are improving to become faster and more accurate. This study aimed to evaluate the accuracy of rapid detection of toxigenic C. difficile using the novel high-speed polymerase chain reaction (PCR) device, PathOC RightGene. These results were compared and evaluated with real-time PCR (qPCR) and enzyme immunoassays (EIA) kit. For this study, 102 C. difficile and 3 Clostridium species isolated from CDI patients were used. These C. difficile isolates were 85 toxigenic and 17 non-toxigenic strains. The results of qPCR served as a standard, and sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the PathOC Right Gene were 99.2%, 99.4%, 100%, 98.8%, and 99.3%, respectively. Turnaround time of qPCR and EIA was 85 and 30 minutes, whereas PathOC RightGene was only 25 minutes including DNA extraction. This novel high-speed PCR device detected toxigenic C. difficile rapidly and accurately.

用于诊断艰难梭菌感染（CDI）的核酸扩增测试正在不断改进，以变得更快，更准确。这项研究旨在评估使用新型高速聚合酶链反应（PCR）设备PathOC RightGene快速检测产毒艰难梭菌的准确性。使用实时荧光定量PCR（qPCR）和酶免疫分析（EIA）试剂盒对这些结果进行比较和评估。在这项研究中，使用了从CDI患者中分离出来的102个艰难梭菌和3个梭菌。这些艰难梭菌分离株为85个产毒菌株和17个非产毒菌株。以qPCR的结果为标准，PathOC Right基因的敏感性，特异性，阳性预测值，阴性预测值和准确性分别为99.2％，99.4％，100％，98.8％和99.3％。qPCR和EIA的处理时间分别为85和30分钟，而PathOC RightGene仅25分钟（包括DNA提取）。这种新颖的高速PCR装置可快速，准确地检测出产毒艰难梭菌。