EUROPattern全自动免疫荧光核型和滴度判读系统检测抗核抗体的应用评价  

The clinical evaluation of antinuclear antibody patterns and titer using automated indirect immuno-fluorescence interpretation system based on EUROPattern Suit technology

作　　者：徐红星[1] 刘艺 朱琴芳[1] 徐卫东[1] XU Hong-xing;LIU Yi;ZHU Qin-fang;XU Wei-dong(Department of Clinical Laboratory, the Affiliated Suzhou Municipal Hospital of Nanjing Medical University, Suzhou Jiangsu 215002,China)

机构地区：[1]南京医科大学附属苏州市立医院本部检验科,江苏苏州215002

出　　处：《江苏大学学报（医学版）》2020年第2期165-168,180,共5页Journal of Jiangsu University：Medicine Edition

摘　　要：目的:评价EUROPattern全自动免疫荧光核型和滴度判读系统对抗核抗体荧光片的应用价值。方法:选取苏州市立医院本部血清标本202例,其中包括确诊的177例自身免疫病患者血清标本及25例健康体检者血清标本。应用Sprinter XL全自动间接免疫荧光仪检测抗核抗体,分别采用EUROPattern Suit全自动判读系统以及传统目视判读方法对两组血清标本抗核抗体的核型及滴度进行分析,比较两种方法的分析结果并进行评价。结果:①全自动判读系统和目视判读方法在202例血清标本中阳性率分别为85.6%和86.1%,两种判读方法阳性率无显著差异(P=0.886);比较两种方法的性能验证指标,灵敏度、特异性、准确度、阳性预测值和阴性预测值,其差异均无显著性(P均>0.05)。②全自动判读系统和目视判读方法显示荧光核型同时阳性169例,同时阴性24例,总体符合率为95.5%,一致性检验Kappa值为0.816。③全自动判读系统与目视判读方法的荧光核型分布显示,其总体一致率为85.1%;不同荧光模式一致率由高到低为核点型(100%)、着丝点型(93.8%)、均质型(91.7%)、核仁型(88.5%)、胞质型(84.6%)、颗粒型和混合型(均80.0%)。④除混合型外,两种方法滴度判读均有较高的符合率(81.8%~100.0%)。结论:与传统目视判读结果比较,全自动荧光判读系统对抗核抗体核型和滴度判读具有较高的灵敏度、特异性及符合率,可以较好地满足临床需求。Objective:To evaluate the clinical application of antinuclear antibody(ANA)patterns and titer using the automated indirect immuno-fluorescence interpretation system based on EUROPattern Suit technology.Methods:A total of 202 serum samples were selected from Suzhou Municipal Hospital,including 177 patients with autoimmune diseases and 25 healthy controls.The antinuclear antibodies of two groups were determined by Sprinter XL automatic immuno-fluorescence analyzer,and then the ANA patterns and titer were evaluated using the EUROPattern Suit automated immuno-fluorescence interpretation system and traditional visual interpretation method.Results:①The positive rates of two methods were respectively 85.6%and 86.1%,and there were no significant difference between two methods(P=0.886);The performance verification indicators,such as sensitivity,specificity,accuracy,positive predictive value and negative predictive value were compared,and none of the differences were significantly(P>0.05).②It was shown that there were 169 positive cases and 24 negative case at the same time detected in two methods,the overall coincidence rate was 95.5%and the Kappa value of the consistency checking was 0.816.③The overall concordance rate of ANA patterns distribution in two methods was 85.1%.The concordance rates of different fluorescence patterns were respectively nuclear dots(100%),centromeres(93.8%),homogeneous(91.7%),nucleolar(88.5%),cytoplasmic(84.6%),speckled and mixed patterns(80.0%).④The concordance rates of ANA titer of every pattern in two methods were higher,ranging from 81.8%to 100.0%,except for the mixed pattern.Conclusion:Compared with the traditional visual interpretation method,the EUROPattern Suit automated fluorescence interpretation system had a higher sensitivity,specificity and concordance rate in interpreting the ANA pattern and titer.This assay can meet clinical requirements.

关 键 词：抗核抗体 EUROPattern Suit全自动荧光判读系统 间接免疫荧光 

分 类 号：R446.6[医药卫生—诊断学]