Increased accuracy of a novel mRNA-based urine test for bladder cancer surveillance
Increased accuracy of a novel mRNA-based urine test for bladder cancer surveillance
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DOI：
10.1111/bju.14019
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发表时间：
2018-01-01
影响因子：
4.5
通讯作者：
Heidegger, Isabel
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文献类型：
--
作者：
Pichler, Renate;Fritz, Josef;Heidegger, Isabel
目的评价Xpert膀胱癌（BC）监护仪与膀胱镜检查和细胞学检查在非肌肉浸润性膀胱癌（NMIBC）肿瘤随访中的诊断准确性。材料和方法本研究前瞻性纳入140例在我院接受常规监测的NMIBC病史患者（ISRCTN研究注册号37210907）。尿液细胞学按照巴黎分类系统进行评估。此外，使用Xpert BC Monitor分析尿液标本，该监视器使用实时PCR测量5种靶mrna （ABL1， CRH, IGF2, UPK1B, ANXA10）。计算描述性分析、诊断准确性(包括敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）、患者工作特征曲线和曲线下面积（AUC）。结果Xpert BC Monitor的总灵敏度（0.84）和NPV（0.93）明显优于膀胱冲洗细胞学检查（0.33和0.76,P < 0.001）。亚组分析证实，与barbotage细胞学（低级别：0.13;pTa: 0.21）相比，Xpert BC Monitor即使在低级别（0.77）和pTa（0.82）疾病中也具有高灵敏度。Xpert BC Monitor和barbotage细胞学的总体特异性相似（0.91 vs 0.94; P = 0.41）。与单独使用Xpert BC Monitor （AUC = 0.87）相比，联合使用Xpert BC Monitor与barbotage细胞学（AUC = 0.85）并没有提高诊断性能。在这项研究中，我们首次报道了Xpert BC Monitor，一种新的基于mrna的尿液检测，在敏感性和NPV方面优于细胞学，即使在低级别和pTa肿瘤中，也没有降低特异性。
ObjectivesTo evaluate the diagnostic accuracy of the Xpert Bladder Cancer (BC) Monitor, compared with cystoscopy and cytology in the oncological follow-up of non-muscle-invasive bladder cancer (NMIBC).Material and MethodsA total of 140 patients with a history of NMIBC undergoing routine surveillance at our institution were enrolled prospectively in this study (ISRCTN study registry number 37210907). Urine cytology was evaluated according to the Paris classification system. In addition, urinary specimens were analysed using the Xpert BC Monitor, which measures five target mRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) using real-time PCR. Descriptive analysis, diagnostic accuracy including sensitivity, specificity, positive (PPV) and negative predictive value (NPV), receiver-operating characteristic curve, and area under the curve (AUC) were calculated.ResultsThe overall sensitivity (0.84) and NPV (0.93) of the Xpert BC Monitor were significantly superior to those of bladder washing cytology (0.33 and 0.76; P < 0.001). Subgroup analyses confirmed the high sensitivity of the Xpert BC Monitor even in low-grade (0.77) and pTa (0.82) disease compared with barbotage cytology (low-grade: 0.13; pTa: 0.21). The overall specificity of the Xpert BC Monitor and barbotage cytology was similar (0.91 vs 0.94; P = 0.41). Combining the Xpert BC Monitor with barbotage cytology (AUC = 0.85) did not enhance diagnostic performance compared with the performance of the Xpert BC Monitor alone (AUC = 0.87).ConclusionIn this study, we report for the first time that the Xpert BC Monitor, a new mRNA-based urine test, outperforms cytology with regard to sensitivity and NPV, even in low-grade and pTa tumours, with no reduction of specificity.