快速乳胶散射免疫比浊法检测尿视黄醇结合蛋白方法学评价  

With rapid latex scattering immune turbidimetric method to detect the urine retinol binding protein and evaluate methodology

作　　者：金月丹 王琳 JIN Yue-dan WANG Lin(Department of inspection in Yiwu Fuyuan Private Hospital of Zhejiang Province, Yiwu 322000, Chin)

机构地区：[1]浙江省义乌復元私立医院检验科

出　　处：《中国生化药物杂志》2017年第5期24-27,共4页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的研究快速乳胶散射免疫比浊法检测尿视黄醇结合蛋白,并进行方法学评价。方法依照美国临床实验室标准委员会（NCCLS）中相关要求,评价本研究方法的试剂灵敏度、精密度、准确度、稳定性、线性范围、分析干扰、特异度。结果经快速乳胶散射免疫比浊法检测尿视黄醇结合蛋白,检测最低限为0.038 1 mg/L;精密度检测重复性为1.198%,中间为5.541%,再现性为6.662%;0~10 mg/L为线性范围;回收率为99.00%和104.00%;在TBIL〈100 mg/L及Hb〈10 mg/L时,RBP的检测不受TBIL、Hb干扰;同尿RBP比对试剂盒在自动化分析仪的检测结果相比分析显示r2=0.972 0,相关度可;对50例临床标本使用2种方法检测显示阳性率,差异不具有统计学意义（χ~2=0.948,P=0.332）。结论使用快速乳胶散射免疫比浊法检测尿视黄醇结合蛋白有高精密度、高准确度、高灵敏度,且抗干扰强、稳定性好。Objective The rapid latex scattering immune turbidimetric method detecting urine retinol binding protein, and evaluate methodology.MethodsIn accordance with the commission of American clinical laboratory standards （NCCLS） requirements, evaluation of the research methods of reagent sensitivity, precision, accuracy, stability, linear range, interference analysis, specific degrees.ResultsWith rapid latex scattering immune turbidity method to detect the urine retinol binding protein, for instance, the minimum detection limit of 0.0381 mg/L;Repeatability precision is 1.198%, intermediate precision is 5.541%, reproducibility precision is 6.662%;The linear range is within 0~10 mg/L;Recovery rate were 99.00% and 104.00% respectively;When TBIL〈100mg/L and Hb〈10mg/L, the detection of Tbil, Hb, RBP interference;With the urine RBP than kit in automatic analyzer compared the test results of analysis showed that r2=0.9720, correlation can be;50 cases of clinical specimens using two methods showed no statistically significant difference positive rate （χ2=0.948, P=0.948）.ConclusionRapid latex scattering immune turbidimetric method were used to detect the urine retinol binding protein, has high precision, high accuracy, the advantages of high sensitivity, stability and anti-jamming is strong, good.

关 键 词：乳胶散射 免疫比浊法 尿视黄醇结合蛋白 方法学评价 

分 类 号：R115[医药卫生—公共卫生与预防医学] R392