Xu Xingxing, Luo Yun, Song Xiaojun, Ying Jianfei, Ye Julian, Lu Yong, Cai Jian, Ma Jian, Wang Xianjun, Yu Wanjun, Wang Yiping, Jin Dazhi
Department of Laboratory Medicine, Zhejiang Chinese Medical University affiliated Hangzhou First Hospital, Hangzhou, Zhejiang, 310006, China; Department of Microbiology, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, 310051, China.
Department of Microbiology, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, 310051, China.
Diagn Microbiol Infect Dis. 2018 Dec;92(4):279-283. doi: 10.1016/j.diagmicrobio.2018.06.021. Epub 2018 Jun 30.
In this study, we compared the performance of an UltraFast LabChip (UL) V280 system for Clostridium difficile detection in stool with that of Xpert C. difficile/Epi and VIDAS CDAB. Among 176 stool specimens, UL V280 detected toxigenic C. difficile in 22 (22/176, 12.5%) with a sensitivity, specificity, positive predictive value, negative predictive value (NPV) of 100.0%, 99.4%, 99.5% and 100.0%, respectively, which were higher than 95.2%, 97.4%, 83.3%, and 99.3% of Xpert C. difficile/Epi (P > 0.05). Notably, the sensitivity and NPV of ULV280 were significantly higher than those of VIDAS CDAB 52.4% (P < 0.001, odds ratio [OR] = 20.0, 95% confidence interval [CI] = 2.26-176.81) and 93.8% (P = 0.002, OR = 10.27, 95% CI = 1.30-81.17). UL V280 turnaround time (35 min) and cost (6.24 Dollars [$]) per specimen were less than those for Xpert C. difficile/Epi (47 min, 59.26 $) and VIDAS CDAB (65 min, 11.70 $). UL V280 possessed an analytical sensitivity limit of 2500 CFU/ml, 95% [CI] = (Ct: 30.76-34.90), and no cross-reactions with other pathogens were found. The study demonstrates that UL V280 based on a microfluidic chip is a rapid, accurate, easy, and cost-effective diagnostic test for toxigenic C. difficile in stool.
在本研究中，我们比较了超快速实验室芯片（UL）V280系统用于粪便中艰难梭菌检测的性能与Xpert艰难梭菌/流行病情原体检测（Xpert C. difficile/Epi）及VIDAS艰难梭菌抗原检测（VIDAS CDAB）的性能。在176份粪便标本中，UL V280检测出22份（22/176，12.5%）产毒艰难梭菌，其灵敏度、特异性、阳性预测值、阴性预测值（NPV）分别为100.0%、99.4%、99.5%和100.0%，高于Xpert艰难梭菌/流行病情原体检测的95.2%、97.4%、83.3%和99.3%（P>0.05）。值得注意的是，UL V280的灵敏度和NPV显著高于VIDAS CDAB，分别为52.4%（P<0.001，优势比[OR]=20.0，95%置信区间[CI]=2.26 - 176.81）和93.8%（P = 0.002，OR = 10.27，95% CI = 1.30 - 81.17）。UL V280的周转时间（35分钟）和每份标本的成本（6.24美元[$]）低于Xpert艰难梭菌/流行病情原体检测（47分钟，59.26美元）和VIDAS CDAB（65分钟，11.70美元）。UL V280的分析灵敏度极限为2500 CFU/ml，95%[CI] =（Ct值：30.76 - 34.90），且未发现与其他病原体的交叉反应。该研究表明，基于微流控芯片的UL V280是一种用于粪便中产毒艰难梭菌的快速、准确、简便且经济高效的诊断检测方法。
