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目的探讨化学发光酶免疫法(CLISA)和免疫印迹法(IB)检测血清中胰岛素自身抗体(IAA)、谷氨酸脱羧酶抗体(GADA)的敏感性和特异性。方法用CLISA法和IB法分别检测13例Ⅰ型糖尿病(T1DM)、61例Ⅱ型糖尿病(T2DM)患者和50例健康对照者血清中的IAA和GADA,观察其敏感性和特异性;用统计学方法分析两种方法的差异性。结果 CLISA法和IB法检测T1DM患者血清中IAA的阳性率分为38.46%、23.07%,GADA的阳性率分别为53.84%、7.69%;检测T2DM患者血清中IAA的阳性率分别为27.86%、18.03%,GADA的阳性率分别为14.75%、3.27%;检测50例对照组IAA的阳性率分别为0.00%、10.00%,GADA阳性率分别为2.00%、2.00%。两种方法检测IAA的敏感性为CLISA>IB,特异性为CLISA>IB;检测GADA的敏感性为CLISA>IB,特异性CLISA=IB。经统计学分析CLISA法检测IAA的敏感性和特异性与IB法检测结果比较,差异均有统计学意义(P<0.05);CLISA法检测GADA敏感性与IB法结果比较有统计学意义(P<0.05),特异性无统计学意义(P>0.05)。结论 CLISA法检测IAA的敏感性和特异性均高于IB法;CLISA法检测GADA的敏感性高于IB法,特异性与IB法比较无统计学差异。
Objective To investigate the sensitivity and specificity of serum autoantibodies (IAA) and glutamic acid decarboxylase antibody (GADA) by CLIA and Western blotting. Methods The serum and serum levels of IAA and GADA in 13 cases of type 1 diabetes mellitus (T1DM), 61 cases of type 2 diabetes mellitus (T2DM) and 50 healthy controls were detected by CLISA and IB respectively. The sensitivity and specificity were observed. Learning methods to analyze the difference between the two methods. Results The positive rates of serum IAA in patients with T1DM were 38.46% and 23.07%, respectively, and the positive rates of GADA were 53.84% and 7.69%, respectively. The positive rates of serum IAA in T2DM were 27.86% and 18.03 %. The positive rates of GADA were 14.75% and 3.27% respectively. The positive rates of IAA in 50 cases of control group were 0.00% and 10.00%, respectively. The positive rates of GADA were 2.00% and 2.00% respectively. The sensitivity of the two methods to detect IAA was CLISA> IB, the specificity was CLISA> IB; the sensitivity of detecting GADA was CLISA> IB, and the specificity of CLISA = IB. The statistical analysis showed that the sensitivity and specificity of CLISA in detecting IAA were significantly different from those in IB (P <0.05). The sensitivity of GISA to CLADA was significantly higher than that of IB (P <0.05), the specificity was not statistically significant (P> 0.05). Conclusions The sensitivity and specificity of CLISA in detecting IAA are higher than those in IB. The sensitivity of CLISA in detecting GADA is higher than that in IB. There is no significant difference between IBSA and IBISA.