Department of Microbiology, Tokyo Medical University, Tokyo, Japan; Department of Infectious Diseases, St Luke's International Hospital, Tokyo, Japan.
Metaboscreen Company, Ltd., Kanagawa, Japan.
J Infect Chemother. 2021 May;27(5):715-721. doi: 10.1016/j.jiac.2020.12.020. Epub 2021 Jan 2.
The incidence of Clostridioides difficile infection (CDI) has been continuously increasing and thereby became an important issue worldwide. Appropriate diagnosis, management, and infection control are required for patients with CDI. Enzyme immunoassay (EIA) is a widely used standard diagnostic tool for C. difficile-specific glutamate dehydrogenase (GDH) and C. difficile toxins (toxins A and B). However, the sensitivity of EIA in detecting C. difficile toxins has been reported to be relatively low, resulting in CDI underdiagnosis. Therefore, nucleic acid amplification tests (NAAT) are recently developed for higher sensitivity/specificity test.
In this study, a total of 279 stool samples submitted for CDI diagnosis were examined using an independently developed new high-speed polymerase chain reaction (PCR) device (PathOC RightGene, Metaboscreen). In parallel, results were compared with those of definitive diagnosis and conventional diagnostic methods (EIA, real-time PCR) to assess the inspection accuracy.
PathOC RightGene showed high sensitivity (96.7%) and specificity (96.7%). Regarding the measurement time, C. difficile-specific and C. difficile toxin genes were simultaneously detected in approximately 25 min for one sample (including the preprocessing and measurement time).
PathOC RightGene has been found to show both excellent sensitivity and rapidity and thus can be used for the reliable and early diagnosis, which are needed for the appropriate management of CDI.
艰难梭菌感染（CDI）的发病率持续上升，已成为全球关注的重要问题。CDI 患者需要进行适当的诊断、管理和感染控制。酶联免疫吸附试验（EIA）是一种广泛用于检测艰难梭状芽孢杆菌谷氨酸脱氢酶（GDH）和艰难梭状芽孢杆菌毒素（毒素 A 和 B）的标准诊断工具。然而，EIA 检测艰难梭状芽孢杆菌毒素的敏感性相对较低，导致 CDI 的漏诊。因此，最近开发了核酸扩增试验（NAAT）以提高检测的敏感性/特异性。
本研究使用自主研发的新型高速聚合酶链反应（PCR）设备（PathOC RightGene，Metaboscreen）对 279 份提交用于 CDI 诊断的粪便样本进行了检测。同时，将检测结果与明确诊断和常规诊断方法（EIA、实时 PCR）进行比较，以评估检测的准确性。
PathOC RightGene 具有较高的敏感性（96.7%）和特异性（96.7%）。在测量时间方面，对于一个样本（包括预处理和测量时间），可在大约 25 分钟内同时检测到艰难梭菌特异性和艰难梭菌毒素基因。
PathOC RightGene 具有出色的敏感性和快速性，可用于可靠且早期的诊断，这对于 CDI 的适当管理非常重要。
