Rabien Anja, Rong Dezhi, Rabenhorst Silke, Schlomm Thorsten, Labonté Flora, Hofbauer Sebastian, Forey Nathalie, Le Calvez-Kelm Florence, Ecke Thorsten H
Department of Urology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Department of Urology, Helios Hospital, Bad Saarow, Germany.
Sci Rep. 2024 Dec 23;14(1):30617. doi: 10.1038/s41598-024-83976-2.
Uromonitor and urinary telomerase reverse transcriptase promoter mutation droplet digital PCR (uTERTpm ddPCR) are non-invasive tests designed to detect bladder cancer in urine. We aimed to compare the diagnostic performance of uTERTpm ddPCR, Uromonitor and urine cytology in detecting bladder cancer. Urine samples were collected prospectively from patients diagnosed with primary (n = 74) and recurrent bladder cancer (n = 20) or benign urological conditions (n = 48) prior to surgical resection. The samples were tested for bladder cancer via uTERTpm ddPCR, Uromonitor and urine cytology. The sensitivity, specificity, and predictive values were calculated for each test, including confidence intervals. The results were stratified by low-grade non-muscle-invasive bladder cancer, high-grade non-muscle-invasive bladder cancer and muscle-invasive bladder cancer. Compared with urine cytology (59.5%, p = 0.005) and Uromonitor (56.8%, p = 0.001), the uTERTpm ddPCR test had the highest sensitivity (79.7%) for the detection of primary bladder cancer. Specificity did not significantly differ. The uTERTpm ddPCR test exhibited superior diagnostic performance over urine cytology and Uromonitor, highlighting its potential for non-invasive primary bladder cancer diagnosis.
尿监测仪和尿端粒酶逆转录酶启动子突变数字PCR（uTERTpm ddPCR）是用于检测尿液中膀胱癌的非侵入性检测方法。我们旨在比较uTERTpm ddPCR、尿监测仪和尿细胞学检查在检测膀胱癌方面的诊断性能。前瞻性收集了在手术切除前被诊断为原发性膀胱癌（n = 74）、复发性膀胱癌（n = 20）或良性泌尿系统疾病（n = 48）患者的尿液样本。通过uTERTpm ddPCR、尿监测仪和尿细胞学检查对样本进行膀胱癌检测。计算每个检测方法的敏感性、特异性和预测值，包括置信区间。结果按低级别非肌层浸润性膀胱癌、高级别非肌层浸润性膀胱癌和肌层浸润性膀胱癌进行分层。与尿细胞学检查（59.5%，p = 0.005）和尿监测仪（56.8%，p = 0.001）相比，uTERTpm ddPCR检测对原发性膀胱癌的检测具有最高的敏感性（79.7%）。特异性无显著差异。uTERTpm ddPCR检测在诊断性能上优于尿细胞学检查和尿监测仪，突出了其在非侵入性原发性膀胱癌诊断中的潜力。
