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  

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

作　　者：齐志宏[1] 邸茜[1] 赵芳[1] 张芳[1] 嵇巍[1] 谢少伟[1] 苏玉君[1] 宋春雁[1] 王健[1] 

机构地区：[1]中国医学科学院北京协和医院检验科,100032

出　　处：《北京医学》2010年第2期127-130,共4页Beijing Medical Journal

摘　　要：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(CystatinC,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(Cr)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CysC快速、准确、精密度高,可用于肾小球滤过功能的评价。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 eases of renal diseases. Results The within-run imprecision （CVs） of patient serum was 1.52 %（low value）, 1.25 %（high value）. The day-to-day imprecision （CVs） was 2,73 %（ low value）, 1.77%（ high value）and total imprecision （CVs） was 3.27 %（ low value）, 2.06 %（ high value）. The average recovery was 97.3%. The linearity studies showed that the method was linear up to 6.00 mg/L. Hemolysis （Hemoglobin up 6.00 g/L）, icterie samples with total bilirubin up to 573 μmol/L, and lipemia up to triglyceride concentration of 12 mmol/L did not interfere with serum Cys C results in this method. The correlation coefficients with serum creatinine clearance （Cer） were -0.9031 for serum Cys C, -0.8433 for serum creatinine （Cr）. In addition, serum Cys C was found to correlate more accurately with the abnormal Ccr than Cr. Conclusions PETIA is convenient and reliable, allows full automation, and is rapid enough to be used in routine chemistry determination of serum Cys C. It can be used in diagnosing glomerular fihration function.

关 键 词：胱抑素C 肾小球滤过率 肌酐清除率 

分 类 号：R446.6[医药卫生—诊断学]