【摘要】 目的:分析和评估多重微球流式荧光免疫技术(MBFFI)检测抗核抗体谱的结果和临床应用价值。方法:同时用MBFFI和免疫印迹技术检测333例自身免疫病患者、44例其他疾病患者和59例健康者血清的抗核抗体谱,进行结果的一致性检验,并用间接免疫荧光技术检测抗核抗体,比较3种方法的灵敏度、特异度。结果:MBFFI与免疫印迹技术检测所有标本抗核抗体谱一致率为83. 26%,Kappa值=0. 655;病例组各项目一致率在79. 88%至99. 40%之间,Kappa值在0. 106至0. 958之间。对照组各项目一致率在96. 61%至100. 00%之间,其他疾病组各项目一致率在95. 45%至100. 00%之间。间接免疫荧光技术诊断自身免疫病的灵敏度最高(P<0. 01),MBFFI诊断自身免疫病的特异度最高(P<0. 05),MBFFI与间接免疫荧光技术联合检测可提高灵敏度(P<0. 01)。结论:多重微球流式荧光免疫技术检测抗核抗体谱与免疫印迹技术相比,一致性尚可,特异度更高,可以替代免疫印迹技术成为新一代的抗核抗体确认试验检测方法。更多还原

【Abstract】 Objective: To analyze and evaluate the results and clinical value of a multiplex bead-based flow fluorescent immunoassay( MBFFI) for the detection of antinuclear antibody spectrum. Methods: Serum antinuclear antibodies were tested by multiplex bead-based flow fluorescent immunoassay and immunoblot assay in 333 patients with autoimmune diseases,44 patients with other diseases and 59 healthy individuals. The consistency of the results was analyzed. Antinuclear antibodies were tested by indirect immunofluorescence assay in all samples. Then sensitivity and specificity of the three methods were compared. Results: The overall concordance rate between the antinuclear antibodies results for all samples by MBFFI and immunoblot was 83. 26%( Kappa = 0. 655).The concordance rates between the results of the two assays in the autoimmune disease patients ranged from 79. 88% to 99. 40%,and Kappa coefficients ranged from 0. 106 to 0. 958. The concordance rates between the results by two assays in controls ranged from96. 61% to 100. 00%,and those in the other diseases were from 95. 45% to 100. 00%. The sensitivity of indirect immunofluorescence in the diagnosis of autoimmune diseases was the highest( P < 0. 01),and the specificity of MBFFI was the highest( P < 0. 05). The combination of the two assays improved the sensitivity( P<0. 01). Conclusion: The multiplex bead-based flow fluorescent immunoassay showed comparable results with those by immunoblot for the detection of antinuclear antibody spectrum and higher specificity. It can replace immunoblot as a novel method of antinuclear antibody confirmation test.更多还原