胶体金免疫层析法视黄醇结合蛋白检测试剂对肾小管功能损伤的诊断价值评价

The Diagnostic Value of RBP Colloidal Gold Assay on Renal Tubular Dysfunction

目的:对胶体金免疫层析法的视黄醇结合蛋白(RBP)检测试剂诊断肾小管损伤的价值进行评价。方法:选择上海柏纳生物技术有限公司生产的视黄醇结合蛋白检测试剂盒(胶体金免疫层析法)与上海太阳生物技术有限公司生产的RBP含量测定试剂盒(酶联免疫法)进行对比试验,分别对临床选取的病例组和对照组的尿液样本进行检测。参考临床单位诊断标准,酶联免疫法结果浓度≥300ng/mL为阳性,<300ng/mL为阴性;胶体金免疫层析法检测结果检测线显色为阳性,不显色为阴性。对两组检验结果进行Kappa一致性检验,分析两种检测方法诊断结果的一致性,同时以临床通用诊断方法为参考,计算胶体金免疫层析法诊断肾小管功能损伤的灵敏度和特异度。结果:两种检测方法的诊断结果一致性良好(市一医院:K=0.9070,95%CI:0.8277～0.9863,P<0.01;市六医院:K=0.9391,95%CI:0.8714～1.000,P<0.01)。胶体金方法诊断肾小管损伤的灵敏度和特异度,市一医院:灵敏度=100%,精确95%CI为:92.45%～100.00%;特异度=91.80%,精确95%CI为:81.90%～97.28%;市六医院:灵敏度=100%,精确95%CI为:91.40%～100.00%;特异度=95.00%,精确95%CI为:86.08%～98.96%。结论:胶体金免疫层析法的视黄醇结合蛋白检测试剂与已批准上市的试剂等效,对肾小管功能损伤的诊断具有重大应用价值。

Objective：To evaluate the value that diagnosis renal tubular damage by colloidal gold immunochromatography assay of retinol-binding protein（RBP）.Methods：Retinol-binding protein kit（colloidal gold immunochromatography） produced by Shanghai bionano Biotechnology Co.,Ltd.and RBP content assay kit（ELISA） produced by Shanghai Sun biotechnology Co.,Ltd.Were selected,comparative tests were used to detect urine samples which were divided into the case group and control group.To ELISA,if concentration is equal or greater than 300 ng mL-1,the result is positive,while low than 300 ng mL-1 will be negative;Coloration of test line means positive wile has no color means negative.Consistency of two detection methods will be analysed by Kappa consistency test,clinical diagnosis is treated as the standard which can help us to calculate the diagnostic sensitivity and specificity of colloidal gold immunochromatography assay.Results：The two detection methods,diagnostic consistency（No.1 hospital：K = 0.9070,95% CI：0.8277～0.9863,P 0.01;No.6 hospital：K = 0.9391,95% CI：0.8714～ 1.000,P 0.01）.The sensitivity and specificity of the colloidal gold immunochromatography assay for diagnosis renal tubular damage,No.1 hospital：sensitivity = 100%,exact 95% CI：92.45%～ 100.00%;specificity = 91.80%,exact 95% CI：81.90%～ 97.28%;No.6 hospitals：sensitivity = 100%,exact 95% CI：92.45% to 100.00%;specificity = 91.80%,exact 95% CI：81.90%～ 97.28%.Conclusion：Colloidal gold immunochromatography assay of retinol-binding protein has a great value for the diagnosis of renal tubular injury.