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出 处:《检验医学》2011年第4期252-255,共4页Laboratory Medicine
摘 要:目的对免疫透射比浊法测定血清视黄醇结合蛋白(RBP)进行方法学和临床应用评价。方法用免疫透射比浊法测定62例肾病患者(肾小球肾炎35例、糖尿病肾病14例、慢性肾功能衰竭13例)、86例肝病患者(急性肝炎21例、肝硬化49例、肝恶性肿瘤16例)及100名健康体检者的血清RBP含量,根据美国临床实验室标准化委员会(NCCLS)相关文件对其进行精密度、线性、准确度等方法学评价以及临床应用初探。结果免疫透射比浊法的批内变异系数(CV)为2.05%~4.35%,批间CV为2.94%~5.41%,总CV为2.71%~8.85%。线性不低于120 mg/L,回归方程为Y=0.934X+4.838,r=0.975。最低检测浓度为1 mg/L。低、中、高浓度回收率分别为109.5%、96.2%、98.8%,总回收率为99.4%。该法与DADE BEHRING特种蛋白仪的相关性良好(r=0.997)。肾病各组的血清RBP含量均高于健康对照组(P均〈0.01),但肾病组内差异均无统计学意义(P〉0.05)。肝病各组的血清RBP含量均低于健康对照组(P均〈0.01),肝病组内比较差异均无统计学意义(P〉0.05)。结论免疫透射比浊法简便、快速、灵敏、结果准确,可用全自动生化分析仪测试,宜于推广。RBP对肝、肾疾病的诊断都有临床意义。Objective To evaluate clinical application and methodology of serum retinol-binding protein(RBP) levels by immune turbidimetry.Methods A total of 62 patients with nephropathy(35 glomerular nephritis cases,14 diabetic nephropathy cases and 13 chronic renal failure cases),86 patients with liver disease(21 acute hepatitis cases,49 hepatic cirrhosis cases and 16 liver malignant tumor cases) and 100 healthy subjects were enrolled.Serum RBP levels were determined by immune turbidimetry.According to National Committee for Clinical Laboratory Standards(NCCLS) documents,the precision,linearity,accuracy and clinical application were evaluated.Results The within-run coefficient of variation(CV) was 2.05%-4.35%,and the between-run CV was 2.94%-5.41%.The total CV was 2.71%-8.85%.The linearity was ≥120 mg/L,and the regression equation was Y=0.934X+4.838(r=0.975).The minimum detection level was 1mg/L.The low,middle and high recoveries were 109.5%,96.2% and 98.8%.The total recovery was 99.4%.The method and the special protein analyzer of DADE BEHRING were correlated well(r=0.997).The serum RBP levels of nephropathy patients were all higher than those of healthy controls(P0.01).The serum RBP levels had no statistical significance between the 3 kinds of nephropathy patients(P0.05).The serum RBP levels of liver disease patients were all lower than those of healthy controls(P0.01).There was no statistical significance in the RBP level between the 3 kinds of liver disease patients(P0.05).Conclusions Immune turbidimetry is simple,rapid,sensitive and accurate,and RBP can be tested by automatic biochemical analyzer.It is suitable for clinical laboratory application.RBP has a clinical significance for liver and kidney disease diagnosis.
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