颗粒增强透射免疫分析法测定血清胱抑素C方法学评价

Analytical performance of particle-enhanced turbidimetric immunoassay for serum cystatin C

目的在HITACHI 7600—010生化分析仪上采用颗粒增强透射免疫分析（PETIA）法测定血清胱抑素C（CysC），评价其方法的性能指标。方法建立分析参数，评价性能指标。结果血清4℃保存稳定7天，-20℃和-70℃保存至少稳定5周。检测限为0．12mg／L，线性范围：0～8．11mg／L。1．08、1．68、2．78mg／L混合血清批内CV分别为：2．6％、3．9％、1．7％；批间CV分别为：3．9％、4．6％、2．2％；总CV分别为：4．1％、4．7％、2．3％。平均回收率为：96．3％，低（1．26mg／L）、高（4．27mg／l）两个水平质控物测定均值（n=30）在允许误差范围内（靶值±靶值×15％）。Hb〈10．8g／L胆红素≤945μmol／LTG〈12．87mmol／L无干扰。不考虑性别和年龄的参考范围为：0．51～1．27mg／L。结论在生化分析仪上采用PETIA法测定血清CysC具有较好的性能指标，很方便和其他相关项目建立组合试验，更好地评估肾小球滤过率。

Objective To establish a automated particle-enhanced turbidimertric assay for cystatin C in serum by Hitachi 7600-010 analyaer,and to evaluate the performance of this assay. Methods Many experiments were done, including analytical parameter choice experiment, methodology evaluation experiment. Results Serum sample was stored at 4 ℃. Cystatin C concentrations were stable for at least 7d,at -20℃ and -70 ℃ stable for at least 5 weeks. The detection limit of the assay was 0.15mg/ L. The linear range was 0-8. llmg/L. The within-run imprecision of pooled serum （1.08,1.68,2.78 mg/L） was 2.6% ,3.9% ,1.7%, respectively, and between-run imprecision was 3.9% ,4.6% ,2.2%, respectively, and total imprecision was 4.1%, 4.7 %, 2.3 % , respectively. The analytical recovery averaged 96.3 %. The measured values of low（1.26mg/L） and high（4.27mg/L） controls fall in the confidence intervals （assigned values± assigned values × 15% ）. The interference was not significant when bilirubin 4945 μmol/L, hemoglobin〈10.8 g/L, triglyceride 〈12.87 mmol/L. The combinedgender reference interval （mean±2s） was 0.51 - 1.27 mg/L. Conclusion This method has better analytical performance. It has improved values to measure serum cystatin C combined relative tests for estimating the glomerular fihration rate.