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

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.