胶乳增强免疫比浊法测定血清胱抑素C方法学评价及临床意义

目的应用美国临床实验室标准化委员会（NCCLS）的标准化评价方案对胶乳增强免疫比浊法测定血清胱抑素C（Cystatin C,CySC）进行初步评价。并探讨血清CysC在肾小球滤过功能中的应用价值。方法测定92例表观健康人、41例肾脏疾病患者血清CysC浓度。分析胶乳增强免疫比浊法测定血清CysC的精密度、准确性、线性范围和干扰因素。结果胶乳增强免疫比浊法测定血清CysC批内变异系数为1．52％（低值）、1．25％（高值）；日间变异系数为2．73％（低值）、1．77％（高值）；总变异系数为3．27％（低值）、2．06％（高值）。平均回收率为97．3％。检测线性范围为0．1～6．00mg／L，线性范围内偏差〈5％。总胆红素（正干扰）在573μmol／L、血红蛋白（负干扰）6g／L、甘油三酯（负干扰）12mmol／L以下对CysC偏差〈5％。基本不受溶血、黄疸和脂血干扰。肾脏疾病患者血清CysC与肌酐清除率（Ccr）相关系数r=-0．9031，肌酐（Or）与Ccr的相关系数r=-0．8433，在评价肾小球滤过功能方面。CysC优于Cr。结论胶乳增强免疫比浊法测定血清CvsC快速、准确、精密度高，可用于肾小球滤过功能的评价。

Evaluation of PETIA for determination of serum cystatin C and its clinical application

Objective To evaluate particle-enhanced turbimetric assay(PETIA) method for determination of serum cystatin C (Cys C) with the National Committee for Clinical Laboratory (NCCLS) projects, and discuss its clinical values in glomerular filtration function. Methods The precision, accuracy, linearity and interference of PETIA were analyzed. This method was used to determine serum Cys C in 92 cases of normals, 41 cases of renal diseases. Results The within-run imprecision (CVs) of patient serum was 1.52 %(low va...