胰岛素化学发光免疫测定法的建立

Establishment of Chemiluminescence Immunoassay in the Determination of Insulin

目的建立化学发光免疫法测定胰岛素及临床糖尿病患者胰岛素治疗跟踪与稳定性的可行性评估.方法 CLIA采用竞争法.结果该方法的灵敏度为1.24 mIU/L,在2.5～160 mIU/L的范围内线性良好.CLIA测定胰岛素的批内与日间变异系数分别为3.05%,4.61%和4.80%,4.92%.在血红蛋白浓度〈2.4 g/L、总胆红素浓度〈342 μmol/L、甘油三酯〈9.9 mmol/L时的干扰率无临床意义.与放射免疫分析法有较好的相关性（r=0.915 6）.结论 CLIA法测定胰岛素能及时有效地满足糖尿病患者的临床需要,有助于进一步对检测试剂盒的研制.

Objective To establish the feasibility evaluation of insulin determined by the CLIA and follow-up diabetic patients treated with insulin. Methods CLIA. Results The sensitivity of method was 1.24 mIU/L. The assay exhibited a good linear correlation within the range of 2.5-160 mIU/L. Within-run and betweenday coefficients of variation were 3.05 %, 4.61% and 4.80 %, 4.92 % respectively. The interference of hemolysis Hb 〈 2.4g/L, TBil 〈 342 μmol/L, TG〈 9.9 mmol/L had no clinical significance. The correlation degree is highly significant with RIA（r= 0. 915 6）. Conclusion CLIA can satisfy the clinical requirement of diabetics mellitus patients treated with insulin immediately and effectively, it will be helpful to develop an assay kit.