Tanaka Sunao, Shimizu Takuto, Pagano Ian, Hogrefe Wayne, Dunbar Sherry, Rosser Charles J, Furuya Hideki
Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
Population Sciences in the Pacific Program, University of Hawaii Cancer Center, Honolulu, HI 96813, USA.
Diagnostics (Basel). 2025 Jul 10;15(14):1749. doi: 10.3390/diagnostics15141749.
: The clinically validated multiplex Oncuria bladder cancer (BC) assay quickly and noninvasively identifies disease risk and tracks treatment success by simultaneously profiling 10 protein biomarkers in voided urine samples. Oncuria uses paramagnetic bead-based fluorescence multiplex technology (xMAP; Luminex, Austin, TX, USA) to simultaneously measure 10 protein analytes in urine [angiogenin, apolipoprotein E, carbonic anhydrase IX (CA9), interleukin-8, matrix metalloproteinase-9 and -10, alpha-1 anti-trypsin, plasminogen activator inhibitor-1, syndecan-1, and vascular endothelial growth factor]. : In a pilot study (N = 36 subjects; 18 with BC), Oncuria performed essentially identically across three different common analyzers (the laser/flow-based FlexMap 3D and 200 systems, and the LED/image-based MagPix system; Luminex). The current study compared Oncuria performance across instrumentation platforms using a larger study population (N = 181 subjects; 51 with BC). : All three analyzers assessed all 10 analytes in identical samples with excellent concordance. The percent coefficient of variation (%CV) in protein concentrations across systems was ≤2.3% for 9/10 analytes, with only CA9 having %CVs > 2.3%. In pairwise correlation plot comparisons between instruments for all 10 biomarkers, R values were 0.999 for 15/30 comparisons and R ≥ 0.995 for 27/30 comparisons; CA9 showed the greatest variability (R = 0.948-0.970). Standard curve slopes were statistically indistinguishable for all 10 biomarkers across analyzers. : The Oncuria BC assay generates comprehensive urinary protein signatures useful for assisting BC diagnosis, predicting treatment response, and tracking disease progression and recurrence. The equivalent performance of the multiplex BC assay using three popular analyzers rationalizes test adoption by CLIA (Clinical Laboratory Improvement Amendments) clinical and research laboratories.
经过临床验证的Oncuria膀胱癌（BC）多重检测法，通过同时分析排尿样本中的10种蛋白质生物标志物，能够快速、无创地识别疾病风险并追踪治疗效果。Oncuria采用基于顺磁珠的荧光多重技术（xMAP；美国德克萨斯州奥斯汀市的Luminex公司），同时检测尿液中的10种蛋白质分析物[血管生成素、载脂蛋白E、碳酸酐酶IX（CA9）、白细胞介素-8、基质金属蛋白酶-9和-10、α-1抗胰蛋白酶、纤溶酶原激活物抑制剂-1、多功能蛋白聚糖-1和血管内皮生长因子]。：在一项试点研究中（N = 36名受试者；18名患有膀胱癌），Oncuria在三种不同的常用分析仪（基于激光/流动的FlexMap 3D和200系统，以及基于LED/图像的MagPix系统；Luminex）上的表现基本相同。当前研究使用更大的研究群体（N = 181名受试者；51名患有膀胱癌）比较了Oncuria在不同仪器平台上的性能。：所有三种分析仪对相同样本中的所有10种分析物进行评估，一致性极佳。9/10种分析物在各系统间蛋白质浓度的变异系数百分比（%CV）≤2.3%，只有CA9的%CV > 2.3%。在所有10种生物标志物的仪器间成对相关性图比较中，15/30次比较的R值为0.999，27/30次比较的R≥0.995；CA9的变异性最大（R = 0.948 - 0.970）。所有10种生物标志物在各分析仪间的标准曲线斜率在统计学上无显著差异。：Oncuria BC检测法可生成全面的尿液蛋白质特征，有助于辅助膀胱癌诊断、预测治疗反应以及追踪疾病进展和复发。使用三种常用分析仪的多重BC检测法具有等效性能，这使得CLIA（临床实验室改进修正案）临床和研究实验室采用该检测法具有合理性。
