检测尿液CK20的胶体金试条研制及初步应用

目的 建立用于筛查膀胱癌的尿液细胞角蛋白20（CK20）单克隆抗体胶体金检测试条,并与常用方法比较.方法 用自行研制的CK20单克隆抗体,建立检测CK20的胶体金试条,对膀胱移行细胞癌（TCC）、泌尿系统良性疾病和健康人尿液进行检测,同时与尿液膀胱癌金标检测板（UBC）和膀胱肿瘤抗原（BTA）检测板的检测结果比较.结果 CK20试条法与UBC、BTA法的敏感性、特异性、阳性似然比、阴性似然比之间均无显著性差异（P＞0.05）.3种方法敏感性随TCC病理分级而增高,但3法差异不显著（P＞0.05）.对20例TCC患者术后监测,3法结果也一致.结论 CK20试条法具有特异性好、敏感性高、操作简单、快速,一般实验室可开展的特点,可用于膀胱癌快速筛查和疗效观察.

Establishment of urine colloid gold test strip by using monoclonal antibody to CK20 and comparative analysis for methodology

Objective To establish a urine colloid gold test strip by using monoclonal antibody to CK20 and compare with other methods.Methods The CK20 monoclonal antibody made by our laboratory was used to produce the test strip.The urine samples from the patients with bladder cancer,benign urinary tract diseases and the normal volunteer were detected with the CK20 colloid gold test strip.The results were compared with UBC and BTA kit for evaluating its clinical application.Results Comparing with UBC and BTA kit,the specificity, positive likelihood ratio and negative likelihood ratio had no significant differences (P>0.05), but the sensitivity, 78%, 68%, 82% for the 3 methods respectively, had significant difference (P<0.05). The sensitivity of CK20 test strip was lower than that of BTA kit, but higher than that of UBC kit. The false positive rate of the 3 methods in detecting 20 non-cancer hematuria samples had significant difference (P<0.05). The positive rate in detecting the samples of bladder cancer patients before and after surgery had significant difference (P<0.005).Conclusion The colloid gold test strip by using monoclonal antibody to CK20 showed high specificity and sensitivity, easy to operate, and may be promoted in simple laboratories. It is suggested that the colloid gold test strip is really worthy of application in quick screening bladder.