title: Simultaneous multi-analyte urinary protein assay for bladder cancer detection.
abstract: BACKGROUND
  The ability to accurately measure multiple proteins simultaneously in a single assay has the potential to markedly improve the efficiency of a myriad of clinical assays. Here, we tested the performance of a new, multiplex protein array platform to quantitate three bladder cancer-associated proteins in urine samples. The following analytes, interleukin 8 (IL8), matrix metallopeptidase 9 (MMP9), and vascular endothelial growth factor A (VEGFA) were monitored using Q-plex, a customized multiplex ELISA system from Quansys Biosciences, and individual target commercial ELISA kits. The performance of the two approaches was compared by evaluating the diagnostic accuracy of the biomarker assays in samples from a cohort of 73 subjects of known bladder cancer status.
  
  
  RESULTS
  The combination biomarker panel analyses revealed an AUROC value of 0.9476 for the Q-plex assay, and 0.9119 for the combination of the single-target ELISA assays. The Q-plex assay achieved an overall diagnostic sensitivity of 0.93 and specificity of 0.81, and the individual target ELISA assays achieved an overall sensitivity of 0.77 and specificity of 0.91.
  
  
  CONCLUSIONS
  Based on these encouraging preliminary data, we believe that the Q-Plex technology is a viable platform that can be exploited as an efficient, highly accurate tool to quantitate multiplex panels of diagnostic proteins in biologic specimens.
authors.affiliation: MD Anderson Cancer Center Orlando, Orlando, FL, USA. crosser@cc.hawaii.edu.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Rosser
authors.forename: Yunfeng
authors.initials: Y
authors.lastname: Dai
authors.forename: Makito
authors.initials: M
authors.lastname: Miyake
authors.forename: Ge
authors.initials: G
authors.lastname: Zhang
authors.forename: Steve
authors.initials: S
authors.lastname: Goodison
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000652:urine*; D016022:Case-Control Studies; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D016209:Interleukin-8 / Q000652:urine; D008297:Male; D020780:Matrix Metalloproteinase 9 / Q000652:urine; D008875:Middle Aged; D040081:Protein Array Analysis / Q000379:methods*; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis*; D042461:Vascular Endothelial Growth Factor A / Q000652:urine
chemical_list: D014408:Biomarkers, Tumor; C508606:CXCL8 protein, human; D016209:Interleukin-8; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C579270:MMP9 protein, human; D020780:Matrix Metalloproteinase 9