全自动生化分析仪血清胱抑素C参考区间的建立

Construct of serum cystatin C reference range detected by automatic biochemical analyzer

目的建立全自动生化分析仪免疫浊度法检测血清胱抑素C(CysC)参考区间。方法依据美国临床和实验室标准化协会文件的要求进行CysC参考区间验证;免疫浊度法检测480例健康体检者血清CysC浓度,建立本实验室参考区间。结果 20例受检者中有2例受检者检测结果在被验证参考区间外。根据480例健康体检者检测结果,建立参考区间为:50岁以下男性0.81～1.23mg/L、女性0.70～1.07mg/L,50岁以上男性0.98～1.89mg/L、女性0.76～1.61mg/L。结论所建立参考区间与试剂盒提供的参考区间有明显差异。血清CysC浓度存在性别及年龄差异,说明建立适合不同本实验室的参考区间十分重要。

Objective To construct serum cystatin C（CysC） reference range detected by automatic biochemical analyzer using immune turbidimetric method.Methods According to document of Clinic and Laboratory Standards Institute,reference range of reagent kit was validated.Serum CysC level was detected among 480 healthy subjects by using immune turbidimetic method to construct laboratory reference range.Results Among 20 subjects,2 cases were with CysC level out of the reference range supplied by reagent kit.Reference ranges,constructed by analyzing the results of 480 subjects,were 0.81-1.23 and 0.70-1.07 mg/L for male and female less than 50 years old,and 0.98-1.89 and 0.76-1.61 mg/L for male and female more than 50 years old.Conclusion Reference range constructed in this study might be statistically different with that of reagent kit.There could be difference of serum CysC level between subjects of different gender and age,and to establish reference range for different range might be very important.