Analytical validation of ONCURIA™ a multiplex bead-based immunoassay for the non-invasive bladder cancer detection.

Background: The objective of our study was to assess the analytical performance of a multiplex assay (Oncuria™) to quantify protein biomarkers towards a bladder cancer associated diagnostic signature in voided urine.

Method: ology: Using Luminex xMAP technology, a custom immunoassay was developed to measure the concentrations of 10 urinary analytes (angiogenin, ANG; apolipoprotein E, APOE; alpha-1 antitrypsin, A1AT; carbonic anhydrase 9, CA9; interleukin 8, IL8; matrix metallopeptidase 9, MMP9; matrix metallopeptidase 10, MMP10; plasminogen activator inhibitor 1, PAI1; syndecan 1, SDC1; vascular endothelial growth factor, VEGF). Selectivity, sensitivity, specificity, precision, linearity, dynamic range, and detection threshold were assessed using recombinant proteins and human urine samples.