中国医学装备2012，Vol.9Issue(6)：5-8,4.
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
摘要
Abstract
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Key words
Immune turbidimetric method/Cystatin C/Methodological evaluation分类
医药卫生引用本文复制引用
郑春苏,邹燕,黄湘宁,黄清松..胶乳增强免疫透射比浊法检测胱抑素C的技术性能评价[J].中国医学装备,2012,9(6):5-8,4.基金项目
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” （）
