连云港地区健康成人血清胱抑素C浓度的分布及其参考区间的建立

Distribution of serum cystatin C and establishment of its reference interval in healthy adults in Lianyungang

目的初步建立连云港地区20~79岁健康成人血清胱抑素C(Cys C)的参考区间。方法采用完全随机化原则选取2019年9月至10月至本院健康体检的参考个体978例,其中男486例,女492例。采用AU5821全自动生化分析仪及其配套试剂检测血清CysC的浓度,并根据CLSIC28-A3和WS/T 402-2012《临床实验室检验项目参考区间的制定》推荐的方法建立血清Cys C的参考区间。结果本地区健康成人血清中CysC的浓度在年龄、性别上的分布差异均具有统计学意义(均P<0.05),故依据性别、年龄建立的血清CysC的参考区间(免疫比浊法)为:20~59岁男性0.61~1.01mg/L,60~79岁男性0.68~1.65 mg/L,20~59岁女性0.54~0.93 mg/L,60~79岁女性0.66~1.31 mg/L。结论血清Cys C的水平受性别和年龄等影响,故实验室有必要建立适宜的参考区间,以期为肾脏相关疾病的辅助诊断、预后评估等提供潜在的临床价值。

Objective To establish reference intervals of serum cystatin C(Cys C)in healthy adults aged 20 to 79 in Lianyungang.Methods According to the principle of complete randomization,a total of 978 healthy examinees were selected from our hospital from September to October,2019,including 486 males and 492 females.Their serum Cys C levels were detected by AU5800 automatic biochemical analyzer and its matching reagents;and the reference intervals were established according to the method recommended by CLSI C28-A3 and WS/T 402-2012"Establishment of Reference Intervals for Clinical Laboratory Test Items".Results The distribution of serum Cys C in healthy adults of this area was statistically significant in terms of age and gender(both P<0.05).Therefore,the reference intervals of serum Cys C(Immunoturbidimetry)established based on gender and age were as below:20 to 59 years old male 0.61-1.01 mg/L,60 to 79 years old male 0.68-1.65 mg/L,20 to 59 years old female 0.54-0.93 mg/L,and 60 to 79 years old female 0.66-1.31 mg/L.Conclusion The serum level of Cys C is affected by gender and age,so it is necessary for laboratory to establish suitable reference intervals in order to provide potential clinical value for the auxiliary diagnosis and prognostic evaluation of kidney-related diseases.