Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms

• Published in: Journal of translational medicine 2024-01, Vol.22 (1), p.8-8, Article 8
• Main Authors: Furuya, Hideki, Sakatani, Toru, Tanaka, Sunao, Murakami, Kaoru, Waldron, Richard T, Hogrefe, Wayne, Rosser, Charles J
• Format: Article
• Language: English
• Subjects: Analysis; Angiogenin; Apolipoprotein E; Apolipoproteins; BCG; BCG vaccines; Biological markers; Biomarkers; Biotechnology industry; Bladder; Bladder cancer; Cancer; Cancer therapies; Cellular biology; Comparative analysis; Development and progression; Diseases; Equipment and supplies; FDA approval; Fluorescence; Gelatinase B; Hematuria; Humans; Immunoassay; In vitro assay; Interleukin 8; Laboratories; Laboratory equipment; Magnetic bead; Matrix metalloproteinase; Metalloproteinase; Multiplex immunoassay; Oncology, Experimental; Patients; Plasminogen activator inhibitors; Prevention; Proteins; Relapse; Risk Assessment; Risk factors; Skin cancer; Software; Stromelysin 2; Surgery; Syndecan; Trypsin; Tumors; Urinalysis; Urinary Bladder Neoplasms - diagnosis; Urinary Bladder Neoplasms - urine; Urine; Vascular endothelial growth factor; Vascular Endothelial Growth Factor A
• ISSN: 1479-5876; 1479-5876
• DOI: 10.1186/s12967-023-04811-2

No single marker of bladder cancer (BC) exists in urine samples with sufficient accuracy for disease diagnosis and treatment monitoring. The multiplex Oncuria BC assay noninvasively quantifies the concentration of 10 protein analytes in voided urine samples to quickly generate a unique molecular profile with proven BC diagnostic and treatment-tracking utility. Test adoption by diagnostic and research laboratories mandates reliably reproducible assay performance across a variety of instrumentation platforms used in different laboratories. We compared the performance of the clinically validated Oncuria BC multiplex immunoassay when data output was generated on three different analyzer systems. Voided urine samples from 36 subjects (18 with BC and 18 Controls) were reacted with Oncuria test reagents in three 96-well microtiter plates on Day 1, and consecutively evaluated on the LED/image-based MagPix, and laser/flow-based Luminex 200 and FlexMap 3D (all xMAP instruments from Luminex Corp., Austin, TX) on Day 2. The BC assay uses magnetic bead-based fluorescence technology (xMAP, Multi-analyte profiling; Luminex) to simultaneously quantify 10 protein analytes in urine specimens [i.e., angiogenin (ANG), apolipoprotein E (ApoE), carbonic anhydrase IX (CA9), CXCL8/interleukin-8 (IL-8), matrix metalloproteinase-9 (MMP-9), matrix metalloproteinase-10 (MMP-10), serpin A1/alpha-1 anti-trypsin (A1AT), serpin E1/plasminogen activator inhibitor-1 (PAI-1), CD138/syndecan-1 (SDC1), and vascular endothelial growth factor-A (VEGF-A)]. All three analyzers quantify fluorescence signals generated by the Oncuria assay. All three platforms categorized all 10 analytes in identical samples at nearly identical concentrations, with variance across systems typically