胶乳增强免疫透射比浊法检测胱抑素C的技术性能评价  

Evaluation on technical performance of the (latex enhanced) immune turbidimetric method for the assay of serum cystatin C

作　　者：郑春苏[1] 邹燕[1] 黄湘宁[1] 黄清松[2] 

机构地区：[1]广东药学院附属第二医院(广州新海医院)检验科,广东广州510300 [2]广东药学院基础学院,广东广州510006

出　　处：《中国医学装备》2012年第6期5-8,共4页China Medical Equipment

基　　金：广东省科技计划项目(20110311)"测定视黄醇结合蛋白的免疫透射比浊法的方法学评价与参考值建立"

摘　　要：目的:对检测血清胱抑素C(Cys-C)的胶乳增强免疫透射比浊法进行方法学的技术性能评价。方法:应用NCCLS的标准化评价方案和全自动生化分析仪,评价胶乳增强免疫透射比浊法测定血清Cys-C的准确度、精密度、线性范围和干扰因素。结果:平均回收率为97.1%;正常值和高值的批内变异系数CV%分别为2.53%和2.31%,批间CV%分别为2.75%和2.68%,日间CV%分别为3.16%和3.03%,总CV%分别为4.12%和3.93%;线性范围为0.00～8.90 mg/L;血红蛋白(负干扰)在5 g/L、总胆红素(正干扰)442 μmol/L和甘油三酯(负干扰)9 mmol/L以下时对血清Cys-C的测定均无显著性干扰,即检测结果基本不受溶血、黄疸和脂浊的影响。结论:胶乳增强免疫透射比浊法的准确度和精密度均符合要求,线性范围宽,具有自动化程度高、检测速度快、成本低、安全等优点,是目前临床实验室常规测定血清Cys-C的首选方法。Objective： To evaluate methodological technical performance of the（latex enhanced）immune turbidimetric method for the assay of serum cystatin C（Cys-C）. Methods： Standardized evaluation program of the NCCLS and automatic biochemical analyzer were used to evaluate the accuracy, precision, linear range and interference factors of the（latex enhanced） mmune turbidimetric method for the assay of serum Cys-C. Results： The average recovery rate was 97.1%; intra coefficient of variation（CV）of normal and high values were 2.53% and 2.31%, batch CV were 2.75% and 2.68%, day CV were 5.16% and 5.05%, and the total CV were 4.12% and 5.95%, respectively; the linear range was 0.00-8.90mg/L; hemoglobin（negative interference）of less than 5g/L, total bilirubin（positive interference）of less than 442 μmol/L and triglycerides（negative interference）of less than 9mmol/L hade no significant interference for the assay of serum Cys-C, namely, test results were not affected by hemolysis, jaundice and lipid turbidity. Conclusions： The accuracy and precision of the（latex enhanced）immune turbidimetric method with a wide linear range meet the requirements. The method has the advantages of high degree of automation, fast speed, low cost and safety, so it is the preferred method for routine determination of serum Cys-C in clinical laboratory.

关 键 词：胶乳增强免疫透射比浊法 胱抑素C 方法学评价 

分 类 号：R446.62[医药卫生—诊断学]