磁性分离酶联免疫测定在糖尿病中的临床应用

Clinical used of IEMA in the patients with diabetes mellitus

目的 :观察磁性分离酶联免疫测定技术水平。方法 :使用磁性分离酶联免疫测定 (IEMA )技术 ,测定糖尿病患者 C-肽、胰岛素。 1型糖尿病 (IDDM) 12例 ,2型糖尿病 (NIDDM) 90例 ,健康人正常对照 2 0例 ,做 OGTT试验 ,使用BIOCHEM IMMU NOSYSTEMS公司发明的 SEROZYME酶联免疫双抗体夹心检测系统和 BIODATA试剂测定胰岛素(INS)和 C-肽 (C-P)。结果 :IEMA批内变系数 (CV% )为 3.95 % ,批间变系数为 6 .72 % ,灵敏度分别为 0 .5 7m U / L和0 .39pmol/ L。 IEMA结果与放射免疫法 (RIA )之间有显著的直线相关性 (P<0 .0 1)。健康人 OGTT试验时 ,空腹胰岛素和 C肽分别为 (15 .76± 6 .32 ) m U/ L 和 (8.71± 16 3.38) pm ol/ L,在 30～ 6 0分钟达到峰值 ,平均为 (5 9.6 4± 7.84) m U/ L 和(2 0 73.83± 2 88.0 9) pm ol/ L。IDDM患者胰岛素和 C-肽空腹水平低 ,OGTT试验无峰值出现 ,而 NIDDM患者峰值延迟。结论 :IEMA是一种灵敏、特异、有效、可与免疫放射法相匹敌的非放射标记的免疫化学检测技术。

Objective: It is to explore the technic level of IEMA. Methods: IEMA technique was used to detect C-P and INS in the patients with DM, including 12 cases of IDDM and 90 cases of NIDDM. SEROZYME systems and BIODATA reagent detected 20 cases of normal adults, whose C-P and INS.Results: The coefficient of variation for intrabatch and interbatch was 3.95% and 6.72%. The he sensitivity was 0.57 mU/L and 0.39 pmol/L.The results expressed excellent correlation between IEMA and RIA (P<0.01). INS and C-P of normal adults were (5.76±6.32) mU/L and (8.71±163.380) pmol/L in an empty stomach. The highest level was found in 30 minutes to 60 minutes. The average results were (59.6±47.84)mU/L and (2073.83±288.09)pmol/L. INS and C-P of IDDM were low in an empty stomach but without highest level of OGTT, and the highest level of NIDDM was lated.Conclusion: The IEMA is a sensitive, specific and useful detecting technique.