Alnimr Amani, Alwazzeh Marwan J, Al-Ameer Ali
Clin Lab. 2019 Aug 1;65(8). doi: 10.7754/Clin.Lab.2019.181252.
Clostridioides (formerly Clostridium) difficile infection (CDI) is linked to misuse of antimicrobials. The prevalence of disease varies with difficulties of establishing the diagnosis because of the lack of sensitivity and specificity of laboratory tests. The clinical impact of upgrading CDI testing from routine to molecular based-algorithm is still unclear. The aim of this study is to assess the impact of upgrading CDI testing from routine to molecular based-algorithm on the management of CDI and evaluate the role of antimicrobials on the course of CDI.
This is an observational case-study. A total of 564 patients were included from whom stool samples were tested by enzyme immunoassay (EIA) and Xpert for C. difficile. Data on the number and results of tests ordered, antimicrobial exposure, comorbidities, and treatment with metronidazole or vancomycin were collected. The main outcome measures were C. difficile tests (EIA and Xpert C. difficile Assay) and prevalence of CDI.
CDI was found in 9 and 10 cases out of 313 and 254 patients tested by the EIA and Xpert C. difficile assay, respectively, giving an overall incidence of 0.03 per 1,000 patient tested. Reduction was noted in the number of tests ordered per patient for presumptive CDI after shifting to the Xpert C. difficile assay which was not statistically significant (p-value 0.2). Also, there was less metronidazole and vancomycin therapy initiated for patients with a negative C. difficile test (p-value 0.2) observed with molecular testing.
Xpert C. difficile testing is a supportive tool for diagnosing CDI with rapid turnaround time that is helpful for patient management and initiating effective infection control measures. The clinical accuracy of the assay is still to be determined in the context of low carriage rate in the local patient population.
艰难梭菌感染（CDI）与抗菌药物的滥用有关。由于实验室检测缺乏敏感性和特异性，疾病的患病率因诊断确立困难而有所不同。将CDI检测从常规方法升级为基于分子的检测算法的临床影响仍不明确。本研究的目的是评估将CDI检测从常规方法升级为基于分子的检测算法对CDI管理的影响，并评估抗菌药物在CDI病程中的作用。
这是一项观察性病例研究。共纳入564例患者，对其粪便样本进行酶免疫测定（EIA）和Xpert艰难梭菌检测。收集检测的数量和结果、抗菌药物暴露情况、合并症以及甲硝唑或万古霉素治疗的数据。主要结局指标为艰难梭菌检测（EIA和Xpert艰难梭菌检测）及CDI患病率。
分别通过EIA和Xpert艰难梭菌检测对313例和254例患者进行检测，其中分别有9例和10例检测出CDI，每1000例检测患者的总体发病率为0.03。转换为Xpert艰难梭菌检测后，每位疑似CDI患者的检测次数有所减少，但差异无统计学意义（p值为0.2）。此外，分子检测显示，艰难梭菌检测结果为阴性的患者开始使用甲硝唑和万古霉素治疗的情况较少（p值为0.2）。
Xpert艰难梭菌检测是一种支持诊断CDI的工具，周转时间快，有助于患者管理并启动有效的感染控制措施。在当地患者群体携带率较低的情况下，该检测的临床准确性仍有待确定。
