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Published October 2013 | Supplemental Material
Journal Article Open

A novel precision-engineered microfiltration device for capture and characterisation of bladder cancer cells in urine


Background: Sensitivity of standard urine cytology for detecting urothelial carcinoma of the bladder (UCB) is low, attributable largely to its inability to process entire samples, paucicellularity and presence of background cells. Objective: Evaluate performance and practical applicability of a novel portable microfiltration device for capture, enumeration and characterisation of exfoliated tumour cells in urine, and compare it with standard urine cytology for UCB detection. Methods: A total of 54 urine and bladder wash samples from patients undergoing surveillance for UCB were prospectively evaluated by standard and microfilter-based urine cytology. Head-to-head comparison of quality and performance metrics, and cost effectiveness was conducted for both methodologies. Results: Five samples were paucicellular by standard cytology; no samples processed by microfilter cytology were paucicellular. Standard cytology had 33.3% more samples with background cells that limited evaluation (p < 0.001). Microfilter cytology was more concordant (κ = 50.4%) than standard cytology (κ = 33.5%) with true UCB diagnosis. Sensitivity, specificity and accuracy were higher for microfilter cytology compared to standard cytology (53.3%/100%/79.2% versus 40%/95.8%/69.9%, respectively). Microfilter-captured cells were amenable to downstream on-chip molecular analyses. A 40 ml sample was processed in under 4 min by microfilter cytology compared to 5.5 min by standard cytology. Median microfilter cytology processing and set-up costs were approximately 63% cheaper and 80 times lower than standard cytology, respectively. Conclusions: The microfiltration device represents a novel non-invasive UCB detection system that is economical, rapid, versatile and has potentially better quality and performance metrics than routine urine cytology, the current standard-of-care.

Additional Information

© 2013 Elsevier Ltd. Available online 9 July 2013. The authors thank Yao-Shan Fan, Marineide Brinn, Carmen Casas, Ana Prada, and Jinghong Peng of the Cytogenetics and Molecular Diagnostics Laboratory at the University of Miami Miller School of Medicine for their technical support. This work was supported by the U.S. National Institutes of Health/National Cancer Institute Grant R33-CA-123027, and the Whittier Bionanotechnology Program. These study sponsors had no involvement in the study design; collection, analysis and interpretation of data; writing of the manuscript; and decision to submit the manuscript for publication.

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