线性免疫印迹法和酶联免疫吸附法检测抗核抗体的比较分析研究

Comparison of LIA and ELISA for Detecting Antinuclear Antibodies

目的:比较分析使用免疫印迹法检测抗核抗体谱(LIA-ANAs)和酶联免疫吸附法(ELISA)检测患者血清中抗核抗体水平的特点,以评价两种方法用于辅助诊断自身免疫性疾病(AID)的临床价值。方法:同时使用免疫印迹法和酶联免疫吸附法检测血清抗核抗体的病例3014例,记录每个病例的检测结果及患者的临床诊断。比较两种方法检测抗核抗体的结果,分析其一致性。3014例中选取AID患者123例,健康对照组80例,比较两种方法检测的敏感度和特异度。结果:LIA法与ELISA法检测抗核抗体结果总一致率为92.20%,经Kappa检验,两者具有较好的一致性(Kappa=0.69)。LIA法和ELISA法检测抗核抗体的敏感度分别为82.1%和78.9%,特异性分别为92.5%和90.0%。两种方法检测自生免疫性疾病患者的ANA敏感度和特异度,差异无统计学意义(P>0.05)。结论:两种方法都具有较高的敏感度和特异度,均可应用于临床检测。两种方法相结合即ELISA法作为初筛试验、LIA法作为确诊试验联合应用更具临床意义。

Objective： To compare LIA and ELISA of detecting antinuclear antibody level in serum in patients, evaluate clinical value for the diagnosis of the two methods in autoimmune diseases（AID）.Method： At the same time, the use of line immunoassay and enzyme-linked immunosorbent assay for detection of antinuclear antibodies were 3014 cases, clinical diagnosis and detection results recorded for eachcase and patients. Comparison of two methods for thedetection of anti nuclear antibodies, analysis of itsconsistency. In 123 AID patients of 3014 cases were selected, 80 healthy controls were detected between the two methods, the sensitivity and specificity.Result： Detection of LIA method and ELISA method of anti nuclear antibodies results the total consistent rate was 92.20%, the Kappa test, two of them have good agreement （Kappa=0.69）. Detection of LIA method and ELISA method, the sensitivity of anti nuclear antibody were 82.1% and 78.9%, specificity of 92.5% and 90.0%. Two methods for detection of spontaneousimmune disease sensitivity and specificity of ANA, no significant difference （P〉0.05）. Conclusion： Both the two methods have high sensitivity and specificity and can be applied to clinical testing. Combining two methods that ELISA as a screening test and LIA as a confirmatory test has more clinical significance for AID diagnosis