Department of Microbiology, St. Marianna University School of Medicine, Kawasaki, Japan; Department of Microbiology, Tokyo Medical University, Tokyo, Japan.
Metaboscreen Co., Ltd., Yokohama, Japan.
Diagn Microbiol Infect Dis. 2021 Feb;99(2):115247. doi: 10.1016/j.diagmicrobio.2020.115247. Epub 2020 Oct 16.
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.
核酸扩增试验用于诊断艰难梭菌感染（CDI）正在变得更快、更准确。本研究旨在评估新型高通量聚合酶链反应（PCR）设备PathOC RightGene 快速检测产毒艰难梭菌的准确性。这些结果与实时 PCR（qPCR）和酶联免疫吸附试验（EIA）试剂盒进行了比较和评估。在这项研究中，使用了 102 株来自 CDI 患者的艰难梭菌和 3 种梭菌属分离株。这些艰难梭菌分离株中，85 株为产毒株，17 株为非产毒株。qPCR 的结果作为标准，PathOC RightGene 的灵敏度、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 的检测周转时间分别为 85 分钟和 30 分钟，而 PathOC RightGene 仅包括 DNA 提取在内的检测时间为 25 分钟。这种新型高通量 PCR 设备可快速、准确地检测产毒艰难梭菌。
