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Abstract：
OBJECTIVE: Assessment of patients with hematuria (aH) remains a challenge in urological practice, balancing the benefits of diagnosing a potentially underlying bladder cancer (UCa) against the risks of possibly unnecessary diagnostic interventions. This study analyzes the potential of an mRNA-based urine assay, the Xpert® Bladder Cancer Detection- CE-IVD (Xpert BC-D), in patients with hematuria.
METHODS: Overall, 368 patients with newly observed painless hematuria and no history of UCa were included in this observational study. Patients received urological workup, including urethrocystoscopy (WLC), upper tract imaging, urine cytology and Xpert BC-D. Patients with positive WLC were recommended to undergo tumor resection (TUR-B).
RESULTS: After excluding non-assessable cases, 324 patients were considered for analysis (188 males, 136 females; median age: 61 years). Eight of twenty-eight patients with a positive TUR-B had Ta low grade (LG) tumors; the others were diagnosed with high grade (HG) lesions (Ta: 4, CIS: 2, T1:11, > T1:3). The Xpert BC-D was more sensitive than urine cytology (96% vs. 61%) (p = 0.002). Increased risk ratios (RR) were observed for gross hematuria, gender, urine cytology, and positive Xpert BC-D (all p < 0.05). Age and positive Xpert BC-D remained independent predictors of UCa in multivariate analysis. Simulating a triage with WLC restricted to patients with positive Xpert BC-D could have saved 240 (74.1%) assessments at the cost of missing one pTa LG tumor.
CONCLUSIONS: The results suggest a potential role for Xpert BC-D in preselecting patients with hematuria for either further invasive diagnosis or an alternate diagnostic procedure.
METHODS: Overall, 368 patients with newly observed painless hematuria and no history of UCa were included in this observational study. Patients received urological workup, including urethrocystoscopy (WLC), upper tract imaging, urine cytology and Xpert BC-D. Patients with positive WLC were recommended to undergo tumor resection (TUR-B).
RESULTS: After excluding non-assessable cases, 324 patients were considered for analysis (188 males, 136 females; median age: 61 years). Eight of twenty-eight patients with a positive TUR-B had Ta low grade (LG) tumors; the others were diagnosed with high grade (HG) lesions (Ta: 4, CIS: 2, T1:11, > T1:3). The Xpert BC-D was more sensitive than urine cytology (96% vs. 61%) (p = 0.002). Increased risk ratios (RR) were observed for gross hematuria, gender, urine cytology, and positive Xpert BC-D (all p < 0.05). Age and positive Xpert BC-D remained independent predictors of UCa in multivariate analysis. Simulating a triage with WLC restricted to patients with positive Xpert BC-D could have saved 240 (74.1%) assessments at the cost of missing one pTa LG tumor.
CONCLUSIONS: The results suggest a potential role for Xpert BC-D in preselecting patients with hematuria for either further invasive diagnosis or an alternate diagnostic procedure.
摘要：
目的：血尿（aH）患者的评估在泌尿外科实践中仍然是一个挑战，平衡诊断潜在潜在潜在膀胱癌（UCa）的益处与可能不必要的诊断干预措施的风险。这项研究分析了基于mRNA的尿液检测的潜力，Xpert®膀胱癌检测-CE-IVD（XpertBC-D），血尿患者。
方法：总的来说，这项观察性研究包括368例新观察到的无痛性血尿且无UCa病史的患者。病人接受了泌尿外科检查,包括尿道膀胱镜检查（WLC），上束成像,尿细胞学和XpertBC-D建议WLC阳性的患者进行肿瘤切除术（TUR-B）。
结果：排除不可评估的病例后，324名患者被考虑进行分析(188名男性，136名女性；平均年龄：61岁）。TUR-B阳性的28例患者中有8例患有Ta低度（LG）肿瘤；其他人则被诊断为高级别（HG）病变（Ta：4，CIS：2，T1：11，>T1：3）。XpertBC-D比尿细胞学更敏感(96%vs.61%)(p=0.002)。观察到肉眼血尿的风险比（RR）增加，性别,尿细胞学,和阳性XpertBC-D（均p<0.05）。在多变量分析中，年龄和阳性XpertBC-D仍然是UCa的独立预测因子。用WLC模拟分诊，仅限于XpertBC-D阳性的患者，可以节省240（74.1％）评估，但以缺少一个pTaLG肿瘤为代价。
结论：结果表明，XpertBC-D在血尿患者的预选中具有潜在的作用，以进行进一步的侵入性诊断或替代诊断程序。
方法：总的来说，这项观察性研究包括368例新观察到的无痛性血尿且无UCa病史的患者。病人接受了泌尿外科检查,包括尿道膀胱镜检查（WLC），上束成像,尿细胞学和XpertBC-D建议WLC阳性的患者进行肿瘤切除术（TUR-B）。
结果：排除不可评估的病例后，324名患者被考虑进行分析(188名男性，136名女性；平均年龄：61岁）。TUR-B阳性的28例患者中有8例患有Ta低度（LG）肿瘤；其他人则被诊断为高级别（HG）病变（Ta：4，CIS：2，T1：11，>T1：3）。XpertBC-D比尿细胞学更敏感(96%vs.61%)(p=0.002)。观察到肉眼血尿的风险比（RR）增加，性别,尿细胞学,和阳性XpertBC-D（均p<0.05）。在多变量分析中，年龄和阳性XpertBC-D仍然是UCa的独立预测因子。用WLC模拟分诊，仅限于XpertBC-D阳性的患者，可以节省240（74.1％）评估，但以缺少一个pTaLG肿瘤为代价。
结论：结果表明，XpertBC-D在血尿患者的预选中具有潜在的作用，以进行进一步的侵入性诊断或替代诊断程序。
