Tritschler Stefan, Scharf Sonja, Karl Alexander, Tilki Derya, Knuechel Ruth, Hartmann Arndt, Stief Christian G, Zaak Dirk
Department of Urology, University of Munich, Munich, Germany.
Eur Urol. 2007 Feb;51(2):403-7; discussion 407-8. doi: 10.1016/j.eururo.2006.08.001. Epub 2006 Aug 15.
The aim of the present study was to validate the sensitivity and specificity of the new "point-of-care" NMP22 BladderChek test compared to photodynamic diagnosis (PDD).
Voided urine samples from 100 patients with suspicion of bladder cancer were collected to perform the NMP22 BladderChek test and voided urinary cytology. The nuclear matrix protein 22 (NMP22) levels were measured by a lateral flow immunochromatographic qualitative assay, using 10 U/ml as the cut-off value. Subsequently patients underwent PDD, using 5-aminolevulinic acid or hexyl-aminolevulinate; previous bladder washings for cytology were collected. Sensitivity and specificity of the NMP22 BladderChek test were compared with cytology and PDD.
Forty of the 100 patients had urothelial malignancies (22 pTa, 4 pT1, 3 pT2, 9 carcinoma in situ, 2 pTx; 16 G1, 6 G2, 18 G3). The sensitivity was 65% for the NMP22 BladderChek test, 44% for voided cytology, 75% for washing cytology, and 93% for PDD. Specificity rates were 40%, 78%, 62%, and 43%, respectively. Positive predictive values were 0.42, 0.58, 0.53, and 0.52 and the negative predictive values 0.63, 0.68, 0.82, and 0.9, respectively.
The results demonstrate that the NMP22 BladderChek is an easily applied test, giving diagnostic findings within 30 min. However, validated by the highly sensitive PDD, the NMP22 BladderChek test demonstrates poor specificity and sensitivity and, therefore, cannot be recommended for screening or surveillance in daily clinical routine use. Further studies with careful patient selection are necessary to identify the patient population that might benefit from the NMP22 BladderChek test.
本研究旨在验证新型“即时检验”NMP22膀胱检测试验相对于光动力诊断（PDD）的敏感性和特异性。
收集100例疑似膀胱癌患者的晨尿样本，进行NMP22膀胱检测试验和尿脱落细胞学检查。采用侧向流免疫层析定性分析法测定核基质蛋白22（NMP22）水平，以10 U/ml作为临界值。随后患者接受使用5-氨基酮戊酸或己基氨基酮戊酸的PDD检查，并收集先前用于细胞学检查的膀胱冲洗液。将NMP22膀胱检测试验的敏感性和特异性与细胞学检查和PDD进行比较。
100例患者中有40例患有尿路上皮恶性肿瘤（22例pTa期、4例pT1期、3例pT2期、9例原位癌、2例pTx期；16例G1级、6例G2级、18例G3级）。NMP22膀胱检测试验的敏感性为65%，尿脱落细胞学检查为44%，冲洗液细胞学检查为75%，PDD为93%。特异性率分别为40%、78%、62%和43%。阳性预测值分别为0.42、0.58、0.53和0.52，阴性预测值分别为0.63、0.68、0.82和0.9。
结果表明，NMP22膀胱检测试验是一种易于应用的检测方法，可在30分钟内得出诊断结果。然而，经高度敏感的PDD验证，NMP22膀胱检测试验的特异性和敏感性较差，因此，不推荐在日常临床常规使用中用于筛查或监测。需要进一步进行仔细选择患者的研究，以确定可能从NMP22膀胱检测试验中获益的患者群体。
