Evaluation of an UltraFast LabChip V280 assay for detection of toxigenic Clostridium difficile

Xingxing Xu; Yun Luo; Xiaojun Song; Jianfei Ying; Julian Ye; Yong Lu; Jian Cai; Jian Ma; Xianjun Wang; Wanjun Yu; Yiping Wang; Dazhi Jin

doi:10.1016/j.diagmicrobio.2018.06.021

Evaluation of an UltraFast LabChip V280 assay for detection of toxigenic Clostridium difficile

Diagn Microbiol Infect Dis. 2018 Dec;92(4):279-283. doi: 10.1016/j.diagmicrobio.2018.06.021. Epub 2018 Jun 30.

Authors

Xingxing Xu¹, Yun Luo², Xiaojun Song², Jianfei Ying³, Julian Ye², Yong Lu³, Jian Cai⁴, Jian Ma⁵, Xianjun Wang⁶, Wanjun Yu⁵, Yiping Wang³, Dazhi Jin⁷

Affiliations

¹ 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.
² Department of Microbiology, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, 310051, China.
³ Department of Laboratory Medicine, Ningbo Yinzhou People's Hospital, Ningbo, Zhejiang, 315040, China.
⁴ Department of Disease Control and Prevention, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, 310051, China.
⁵ Department of Respiratory Medicine, Ningbo Yinzhou People's Hospital, Ningbo, Zhejiang, 315040, China.
⁶ Department of Laboratory Medicine, Zhejiang Chinese Medical University affiliated Hangzhou First Hospital, Hangzhou, Zhejiang, 310006, China.
⁷ Department of Microbiology, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, 310051, China. Electronic address: dzjin@cdc.zj.cn.

PMID: 30029809
DOI: 10.1016/j.diagmicrobio.2018.06.021

Abstract

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.

Keywords: Clinical evaluation; Clostridium difficile; Lab-on-a-chip technology; Ultrafast diagnosis.

MeSH terms

Bacterial Toxins / genetics*
Clostridioides difficile / classification*
Clostridioides difficile / genetics*
Clostridium Infections / diagnosis*
Clostridium Infections / microbiology*
Humans
Lab-On-A-Chip Devices*
Molecular Typing / instrumentation
Molecular Typing / methods*
Polymerase Chain Reaction
Reproducibility of Results
Sensitivity and Specificity

Substances

Bacterial Toxins