目的 建立本实验室人血清胰岛素(insulin)水平的参考范围并且调杳其测定稳定性.方法 采用Architect i2000化学发光免疫分析仪和相应的检测试剂、校准品和质控品检测血清胰岛素值并评价检测方法 .测定413名健康成年人血清胰岛素水平,分析各项生理和实验室指标对胰岛素的影响,建立本实验室的胰岛素参考范围,并对胰岛素在不同温度下的稳定性进行探讨.结果 胰岛素的批内和天间不精密度分别为1.67%和2.60%,检测精密性良好,符合临床使用要求.按照每10岁1个年龄间隔分为4个年龄组,组间胰岛素水平(中位数分别为5.6、5.2、5.3、5.7 mU/L)差异无统计学意义(X<'2>=1.929,P>0.05).女件胰岛素水平(中位数为5.7 mU/L)明显高于男性(中位数为5.0mU/L)(Z=3.696,P<0.01).以第97.5%位数为参考值上限,第2.5%位数为参考值下限,建立不同性别的胰岛素参考范围.女性胰岛素的参考范围为2.6～11.8 mU/L,男性胰岛素的参考范围为2.3～11.6 mU/L,不同于胰岛素其他检测方法 的参考范围.胰岛素与体重指数和三酰甘油旱明显正相关(r值分别为0.115、0.143,P值分别为0.019、0.004),与高密度脂蛋白呈明显负相关(r=-0.179,P=0.000).25℃胰岛素活性可稳定4 h,4 ℃可稳定24 h,-20℃胰岛素至少可以稳定7 d.结论 性别是影响人血清胰岛素水平的重要生理因素,应根据不同性别设立胰岛素的参考范围.胰岛素免疫学活性在各种温度条件下并非很稳定.%Objective To establish the reference range of serum human serum insulin levels in our laboratory and investigate measurement stability, Methods The automated Architect i2000 chemiluminescence immunoassay, calibrator and quality control materials were used to measure concentration of serum insulin. Totally 413 cases of healthy adults were enrolled. The physiologic characteristics and the influence of laboratory markers on insulin levels were analyzed. Then the reference range in our laboratory was established. The thermal stability of insulin at different temperatures was investigated. Results Within-run imprecision and between-day imprecision of the automated Architect i2000 insulin assay were 1.67% and 2. 6%, which indicated that this system had good analytical performance. The subjects were classified into 4 groups according to age range ( 10 years). There was no significant difference among four age groups (the median is 5. 6, 5.2, 5.3 and 5. 7 mU/L) (X<'2> = 1. 929,P >0.05). However, the insulin levels were higher in female ( median = 5.7 mU/L) than male ( median = 5.0 mU/L) ( Z = 3.696, P < 0.01 ). The reference range was established based on the 2. 5 and 97.5 percentile values. The reference range of insulin for female was 2. 6-11.8 mU/L and 2. 3-11.6 mU/L for men, which differed from that of other insulin assay. Insulin had a positive correlation with BMI (r =0. 115 ,P =0. 019) and triglyeeride (r =0.143 ,P = 0. 004), and a negative correlation with high density lipoprotein (r = -0.179, P = 0.000). Insulin was stable at 25 ℃ for at least 4 hours or 4 ℃ for 24 hours or could be extended to at least 7 days when stored at -20 ℃. Conclusion Gender is an important physiologic characteristic which has an impact on human serum insuhn level. Insulin reference range should be established according to gender. Insulin immunoreactivity was not very stable at different temperatures.
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