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Effectiveness of a Two-Step Testing Algorithm for Reliable and Cost-Effective Detection of Clostridium difficile Infection in a Tertiary Care Hospital in Saudi Arabia

机译:在沙特阿拉伯一家三级护理医院中可靠且经济高效地检测艰难梭菌感染的两步测试算法的有效性

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摘要

The aim of this study was to evaluate the effectiveness of a two-step algorithm for the detection of Clostridium difficile infection. Setting and Design: A two-step testing algorithm was evaluated for testing stool samples from patients suspected of Clostridium difficile infection (CDI). A total of 103 stool specimens were tested using the C. diff Quik Chek Complete enzyme immunoassay (EIA) test and the Xpert C. difficile PCR test. A two-step algorithm was implemented, and data from 3518 patient samples tested during a two-year period after implementation were analyzed to evaluate the effectiveness. The sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of the Quik Chek Complete EIA test were calculated using the Xpert C. difficile PCR test as a reference method. The sensitivity, specificity, PPV, and NPV of the Quik Chek Complete EIA test for C. difficile toxin were 46.7%, 100%, 100%, and 91%, respectively. The two-step algorithm, which combined the Quik Chek Complete EIA with Xpert C. difficile PCR, improved the sensitivity and also provided rapid detection. When algorithm-based testing was performed daily, there was a 66% reduction in turnaround time compared to batch testing using a lengthy ELISA procedure. Postimplementation data analysis showed that almost 89% of the samples could be reported immediately by initial screening with Quik Chek Complete EIA. Only 11% of the samples gave discrepant results and required PCR confirmation. According to our results, the two-step algorithm is an effective tool for the rapid and reliable detection of toxigenic C. difficile from stool samples.
机译:这项研究的目的是评估两步法检测艰难梭菌感染的有效性。设置和设计:评估了两步测试算法,以测试疑似艰难梭菌感染(CDI)患者的粪便样本。使用diff。C. diff Quik Chek完全酶免疫分析(EIA)测试和Xpert艰难梭菌PCR测试测试了总共103个粪便标本。实施了两步算法,并在实施后的两年内分析了来自3518名患者样本的数据,以评估其有效性。使用Xpert艰难梭菌PCR试验作为参考方法,计算了Quik Chek Complete EIA试验的敏感性,特异性以及阳性和阴性预测值(PPV,NPV)。 Quik Chek Complete EIA测试对艰难梭菌毒素的敏感性,特异性,PPV和NPV分别为46.7%,100%,100%和91%。两步算法将Quik Chek Complete EIA与Xpert C. difficile PCR相结合,提高了灵敏度并提供了快速检测。每天进行基于算法的测试时,与使用冗长的ELISA程序进行批量测试相比,周转时间减少了66%。实施后的数据分析表明,使用Quik Chek Complete EIA进行初步筛选可立即报告几乎89%的样品。只有11%的样品给出了不一致的结果,并需要进行PCR确认。根据我们的结果,两步算法是从粪便样品中快速,可靠地检测出艰难梭菌的有效工具。

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