Department of Clinical Laboratory, Peking University People's Hospital, Beijing, China.
College of Life Sciences, Peking University, Beijing, China.
Dis Markers. 2020 May 8;2020:3424039. doi: 10.1155/2020/3424039. eCollection 2020.
To evaluate the performance of the nuclear matrix protein 22 (NMP22) BladderChek test in urothelial carcinoma (UC).
We retrospectively analyzed 1318 patients who performed the NMP22 BladderChek tests. Of them, 103 were primary UC patients, 90 were surgical treatment UC patients, and 1125 were benign disease patients. The performance of the NMP22 BladderChek test for the diagnosis of primary and recurrent UC was evaluated. Moreover, the performance of urine cytology and the NMP22 BladderChek test for the diagnosis of primary UC was compared in 90 available subjects including 48 primary UC patients and 42 benign disease patients.
The sensitivity and specificity of the NMP22 BladderChek test were 37.9% and 95.8%, respectively, for the diagnosis of primary UC ( = 1228). The corresponding parameters of the NMP22 BladderChek test were 31.0% and 88.5%, respectively, for the diagnosis of recurrent UC ( = 90). The sensitivity and specificity of urine cytology were 54.2% and 97.6%, respectively, for the diagnosis of primary UC ( = 90); the corresponding parameters of the NMP22 BladderChek test were 41.7% and 83.3%, respectively; the corresponding parameters of the two tests combination were 64.6% and 83.3%, respectively. There was a significant difference in the performance between the NMP22 BladderChek test and urine cytology or the combination of two tests ( = 0.017 and 0.001, respectively).
The NMP22 BladderChek test has a low sensitivity for detecting primary and recurrent UC. Urine cytology is superior to the NMP22 BladderChek test, and combined use of the two tests improves the sensitivity in the detection of primary UC.
评估核基质蛋白 22（NMP22）膀胱检测试剂盒（BladderChek）在尿路上皮癌（UC）中的应用性能。
我们回顾性分析了 1318 例接受 NMP22 BladderChek 检测的患者。其中，103 例为原发性 UC 患者，90 例为接受手术治疗的 UC 患者，1125 例为良性疾病患者。评估 NMP22 BladderChek 试验对原发性和复发性 UC 的诊断性能。此外，在 90 例可评估的患者（包括 48 例原发性 UC 患者和 42 例良性疾病患者）中比较尿细胞学和 NMP22 BladderChek 试验对原发性 UC 的诊断性能。
NMP22 BladderChek 试验对原发性 UC 的诊断敏感性和特异性分别为 37.9%和 95.8%（=1228）。相应的参数分别为 31.0%和 88.5%（=90）。NMP22 BladderChek 试验对复发性 UC 的诊断敏感性和特异性分别为 31.0%和 88.5%（=90）。尿细胞学的敏感性和特异性分别为 54.2%和 97.6%（=90）；NMP22 BladderChek 试验的相应参数分别为 41.7%和 83.3%；两项检测联合的相应参数分别为 64.6%和 83.3%。NMP22 BladderChek 试验与尿细胞学或两项检测联合的性能之间存在显著差异（=0.017 和 0.001）。
NMP22 BladderChek 试验对原发性和复发性 UC 的检出敏感性较低。尿细胞学优于 NMP22 BladderChek 试验，两者联合使用可提高原发性 UC 的检出敏感性。
