胰岛素、C肽RIA检测中的室内质量控制

Intra-laboratory Quality Control of RIA for Insulin and C-Peptide

本文介绍了胰岛素、Ｃ肽ＲＩＡ检测中的三种室内质控方法，即质控血清监测法，两样本Ｙｏｕｄｅｎ图监测法和标准曲线参数监测法，并对其结果做了初步分析。三种室内质控方法的应用，保证了每一批测定结果的准确可靠、提高了不同批实验结果的可比性。本文还对胰岛素、Ｃ肽ＲＩＡ检测中使用的试剂盒进行了方法学评价。胰岛素、Ｃ肽测定的批内ＣＶ分别为５．４８％和９．９８％；批间ＣＶ分别为１０．５４％和１４．５６％；平均回收率分别为１０２．６％和９８．７％；灵敏度分别为１．２５ｍＵ／Ｌ和０．０２ｎｍｏｌ／Ｌ。测定了１８４名正常人空腹血清胰岛素和Ｃ肽的含量，分别为８．３５±４．４７ｍＵ／Ｌ和０．２５～１．３２ｎｍｏｌ／Ｌ。与文献报告的正常值接近。

Three kinds of intra-laboratory quality control tests of RIA for serum insulin and C-peptide,i.e.monitoring by quality control serum,by two-sample Youden plotting and by standard curve parameter are described in the present paper.Analysis of the results demonstrated that three QC tests could ensure the precision of data within assay and improve the consistency between assays. Evaluation of insulin and C-peptide RIA kits showed the following results: insulin─intra-assay CV─5.48%.inter-assay CV 10.54%.recovery rate 102.6%,limit of detection 1.25mU/L and C-peptide,9.98%,14.56%,98.7%,0.02nmol/L,respectively.Serum level of insulin in 184 healthy subjects was 8.35±4.47mU/L and that of c-peptide 0.25￣1.32 nmol/L.