免疫反应性胰岛素测定标准化的初步探讨

Approach to the standardization of immuno-reactive insulin assay

目的 探讨胰岛素测定标准化的方法。方法以多种常用的胰岛素测定试剂盒对同批标本进行测定，然后以统一的高纯度人胰岛素标准品代替原试剂盒标准观察测定结果可比性的改善，再以测定系列浓度标准品的测定值对靶值进行回归处理，以回归方程校正标本测定值，分析可比性的改善情况。结果不同测定方法测定值的变异系数（ＣＶ）可达３０％。应用统一标准品后，变异系数减小；进行回归处理后，变异系数进一步减小，可比性进一步改善。结论 胰岛素测定的标准化十分重要，应用统一的高纯度的人胰岛素标准品，可改善部分差异。各实验室测定值通过对某中心的参考标准品进行回归校正，可使相互间可比性进一步改善。

Objective To explore the method of standardization of insulin assay. Methods Identical serum samples were measured with several insulin assay kits. A common insulin standard was used instead of the kit standard so as to observe the improvement of comparability. Linear regression of different assay results to the target values of a set concentrations of insulin standard,was made. The linear regression equation was used to correct the assay results. Results The CVS of the different assay results can exceed 30%. After using a common pure human insulin standard,the CVS decreased; after processing with linear regression,CVS decreased much more,and the comparability improved further. Conclusion The standardization of insulin measurement is very important. Using high quality of pure human insulin as an assay standard can partially reduce the differences. Linear regression to a reference standard of a center can improve comparability further more.