title: Clinical results of microfluidic antibody-independent peripheral blood circulating tumor cell capture for the diagnosis of lung cancer.
abstract: OBJECTIVE
  The ability to capture and characterize peripheral blood circulating tumor cells has the potential for the development of a blood test for cancer. The aim of this study was to evaluate the diagnostic performance of microfluidic technology as a proof-of-concept study.
  
  
  METHODS
  Blood from patients undergoing surgery for known or suspected lung cancer was obtained and processed using a microfluidic biochip. Diagnostic performance was evaluated against the reference of cancer identified within surgically obtained formalin-fixed paraffin embedded specimens reported by a principal pathologist. Agreement was assessed in a sample reported by a second independent pathologist. Sensitivity- and specificity-weighted analyses were undertaken.
  
  
  RESULTS
  From March 2011 to October 2012, 46 patients at our institution donated blood for research. Cancer was the underlying diagnosis in 43 (94%); 34 (79%) of the patients had primary lung cancer. The proportion of patients with cancer in which atypical cells suspicious for cancer were identified on hematoxylin and eosin staining was 16/43 (37%) by the principal pathologist and 10/17 (59%) by the second pathologist. On sensitivity-weighted analysis, the sensitivity of the biochip was 54% (95% confidence interval [CI], 37-72) and the specificity was 33% (95% CI, 2-91). On specificity-weighted analysis, the sensitivity was 43% (95% CI, 21-71) and the specificity was 100% (95% CI, 5-100).
  
  
  CONCLUSIONS
  This work highlights the potential of microfluidic technology to develop a blood test for the diagnosis of cancer using peripheral blood; conventional clinical criteria can be used as a proof-of-concept of what may be possible with today's technology.
authors.affiliation: National Heart and Lung Division, Imperial College, London, United Kingdom; Academic Division of Thoracic Surgery, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom. Electronic address: e.lim@rbht.nhs.uk.
authors.forename: Eric
authors.initials: E
authors.lastname: Lim
authors.affiliation: Academic Division of Thoracic Surgery, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Andee
authors.initials: A
authors.lastname: Tay
authors.affiliation: National Heart and Lung Division, Imperial College, London, United Kingdom; Department of Histopathology, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Jan
authors.initials: J
authors.lastname: Von Der Thusen
authors.affiliation: National Heart and Lung Division, Imperial College, London, United Kingdom; Academic Division of Thoracic Surgery, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Maxim B
authors.initials: MB
authors.lastname: Freidin
authors.affiliation: Academic Division of Thoracic Surgery, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Anikin
authors.affiliation: National Heart and Lung Division, Imperial College, London, United Kingdom; Department of Histopathology, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Nicholson
mesh_terms: D000328:Adult; D000368:Aged; D000906:Antibodies; D014408:Biomarkers, Tumor / Q000097:blood / Q000276:immunology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D008297:Male; D046210:Microfluidic Analytical Techniques; D008875:Middle Aged; D009360:Neoplastic Cells, Circulating / Q000276:immunology / Q000473:pathology*; D015588:Observer Variation; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D013194:Staining and Labeling
chemical_list: D000906:Antibodies; D014408:Biomarkers, Tumor