Department of Urology, Central Hospital of Bolzano, Bolzano, Italy.
Department of Pathology, Central Hospital of Bolzano, Bolzano, Italy.
Cancer Cytopathol. 2019 Jul;127(7):465-469. doi: 10.1002/cncy.22152. Epub 2019 Jun 2.
The objective of this study was to evaluate the diagnostic accuracy of the Bladder EpiCheck test in the follow-up of patients with non-muscle-invasive bladder cancer (NMIBC) and to compare it with the accuracy of urinary cytology, cystoscopy, and/or histology.
In total, 243 patients were enrolled in the current study. Patients were evaluated by voided urine cytology, by the Bladder EpiCheck test, and by white-light cystoscopy.
Overall sensitivity was 33.3% for cytology, 62.3% for Bladder EpiCheck, and 66.7% for the 2 tests combined. The sensitivity of cytology increased from 7.7% in low-grade (LG) tumors to 66.6% in high-grade (HG) tumors; whereas, for the Bladder EpiCheck test, the sensitivity was 46.1% in LG tumors and 83.3% in HG tumors. Combined cytology and Bladder EpiCheck testing yielded an overall sensitivity of 56.4% for LG tumors and 90% for HG tumors. Overall specificity was 98.6% for cytology, 86.3% for Bladder EpiCheck, and 85.6% for the 2 tests combined. The positive predictive value was 92% for cytology and 68.2% for Bladder EpiCheck. For the 2 tests combined, it was 68.6%. The negative predictive value was similar for the 2 tests: 75.8% for cytology, 82.9% for Bladder EpiCheck, and 84.5% for the 2 tests combined.
The sensitivity of the Bladder EpiCheck test was significantly higher than that of cytology. The test performed very well in terms of specificity but could not reach the high value of cytology. The positive predictive value was higher for Bladder EpiCheck, whereas the negative predictive value was approximately the same for both tests.
本研究旨在评估 Bladder EpiCheck 检测在非肌层浸润性膀胱癌（NMIBC）患者随访中的诊断准确性，并与尿细胞学、膀胱镜检查和/或组织学的准确性进行比较。
本研究共纳入 243 例患者。患者通过尿液细胞学检查、膀胱 EpiCheck 检查和白光膀胱镜检查进行评估。
细胞学检查的总敏感性为 33.3%，膀胱 EpiCheck 检查的敏感性为 62.3%，两者联合检查的敏感性为 66.7%。细胞学检查的敏感性从低级别（LG）肿瘤的 7.7%增加到高级别（HG）肿瘤的 66.6%；而对于膀胱 EpiCheck 检查，LG 肿瘤的敏感性为 46.1%，HG 肿瘤的敏感性为 83.3%。联合细胞学和膀胱 EpiCheck 检查的总敏感性分别为 LG 肿瘤的 56.4%和 HG 肿瘤的 90%。细胞学检查的总特异性为 98.6%，膀胱 EpiCheck 检查的特异性为 86.3%，两者联合检查的特异性为 85.6%。细胞学检查的阳性预测值为 92%，膀胱 EpiCheck 检查的阳性预测值为 68.2%。对于两种检查联合，阳性预测值为 68.6%。两种检查的阴性预测值相似：细胞学检查为 75.8%，膀胱 EpiCheck 检查为 82.9%，两种检查联合的阴性预测值为 84.5%。
膀胱 EpiCheck 检查的敏感性明显高于细胞学检查。该检查在特异性方面表现出色，但无法达到细胞学检查的高值。膀胱 EpiCheck 检查的阳性预测值较高，而两种检查的阴性预测值大致相同。
