EUROPattern全自动免疫核型及滴度判读系统检测抗核抗体的评价与合理应用

doi:10.3969/j.issn.1673-8640.2017.12.017

检验医学 ›› 2017, Vol. 32 ›› Issue (12): 1143-1147.DOI: 10.3969/j.issn.1673-8640.2017.12.017

• 技术研究与评价·论著 • 上一篇下一篇

EUROPattern全自动免疫核型及滴度判读系统检测抗核抗体的评价与合理应用

贾汝琳, 李云, 赵静, 朱雷, 杨冬月, 何菁, 栗占国

北京大学人民医院风湿免疫科 “风湿病机制及免疫诊断”北京市重点实验室BZ0135,北京 100044

收稿日期:2016-12-22 出版日期:2017-12-30 发布日期:2018-01-10
作者简介:null
作者简介：贾汝琳,女,1974年生,学士,主管技师,主要从事免疫学实验室诊断和基础研究。
基金资助:
国家自然科学基金项目（81373117、31570880）

EUROPattern auto-reading system for the determination of anti-nuclear antibody

JIA Rulin, LI Yun, ZHAO Jing, ZHU Lei, YANG Dongyue, HE Jing, LI Zhanguo

Department of Rheumatology and Immunology,Peking University People's Hospital,Beijing Key Laboratory for Rheumatism Mechanism and Immune Diagnosis BZ0135,Beijing 100044,China

Received:2016-12-22 Online:2017-12-30 Published:2018-01-10

摘要/Abstract

摘要：

目的评价EUROPattern全自动免疫核型及滴度判读系统（EPA）判读抗核抗体（ANA）荧光片的应用价值。方法采用以HEp-2细胞及猴肝细胞为基质的生物薄片间接免疫荧光法（IIF）检测836例疑似自身免疫性疾病（AID）患者的血清ANA,并用EPA和人工判读方法平行判读荧光片,比较判读结果的一致性。结果 EPA判读ANA荧光片的阴/阳性结果与人工判读方法判读结果的整体符合率为96.29%（K=0.92,P<0.05）,以人工判读方法的判读结果为标准,EPA判读的敏感性为99.70%,特异性为94.02%,经Spearman相关性分析, 2个组判读结果呈正相关（r=0.93,P<0.05）。单一核型荧光模式的符合率为93.46%,复合核型荧光模式主核型的符合率为91.78%;单一核型荧光模式抗体滴度的符合率为90.95%,复合核型荧光模式主核型抗体滴度的符合率为94.03%。实验结果批间差异小,阴性质控变异系数为0.00%,弱阳性质控变异系数为2.44%,阳性质控变异系数为1.78%。结论 EPA判读ANA荧光片的结果在阴/阳性、荧光模式、抗体滴度方面都与人工判读的结果具有一致性,同时EPA判读相较于人工判读有自动、标准、节约人力资源等优势,对提高AID的实验诊断水平有一定的实用价值。

关键词: EUROPattern全自动免疫核型及滴度判读系统, 抗核抗体, 间接免疫荧光法

Abstract:

Objective To evaluate EUROPattern auto-reading system（EPA） for the determination of anti-nuclear antibody（ANA） by indirect immunofluorescence（IIF）. Methods Biochips coated with HEp-2 cells and monkey liver cells by IIF were used to determine serum ANA in 836 cases of suspected autoimmune diseases（AID）. The fluorescence patterns were recognized by EPA and manual visual interpretation in parallel. The consistency was evaluated. Results The consistency rate was 96.29%（K=0.92,P<0.05） between EPA and manual visual interpretation regarding positive/negative classification. The results of manual visual interpretation were as standard,and the sensitivity and specificity of EPA were 99.70% and 94.02%. Through Spearman correlation analysis,there was a positive correlation between the 2 methods（r=0.93,P<0.05）. The consistency rates of single-pattern recognition and mixed-pattern recognition between the 2 methods were 93.46% and 91.78%,respectively. The consistency rates of the 2 methods for antibody titer evaluation were 90.95% and 94.03%. The coefficient of variation of negative control was 0.00%,that of weak positive control was 2.44%,and that of positive control was 1.78%. Conclusions EPA agrees well with manual visual interpretation,and it takes the advantages of automation,standardization and saving labor,as well as obtains practical significance for improving the diagnosis of AID.

Key words: EUROPattern auto-reading system, Anti-nuclear antibody, Indirect immunofluorescence

中图分类号:

R446.61

贾汝琳, 李云, 赵静, 朱雷, 杨冬月, 何菁, 栗占国. EUROPattern全自动免疫核型及滴度判读系统检测抗核抗体的评价与合理应用[J]. 检验医学, 2017, 32(12): 1143-1147.

JIA Rulin, LI Yun, ZHAO Jing, ZHU Lei, YANG Dongyue, HE Jing, LI Zhanguo. EUROPattern auto-reading system for the determination of anti-nuclear antibody[J]. Laboratory Medicine, 2017, 32(12): 1143-1147.

图/表 4

表1 EPA和人工判读方法判读荧光模式的比较

核型	人工判读方法判读	EPA判读	判读符合率（%）
单一核型	260	243	93.46
核颗粒型	128	119	92.97
核均质型	73	70	95.89
胞浆型	22	21	95.45
着丝点型	21	18	85.71
核仁型	14	13	92.86
核膜型	2	2	100.00
复合核型
主核型	73	67	91.78
合计	333	310	93.09

图1 ANA HEp-2常见八大荧光核型及肝片核型注：（a）核颗粒型;（b）核均质型;（c）胞浆型;（d）着丝点型;（e）核点型;（f）核仁型;（g）核膜型;（h）有丝分裂型;（i）猴肝

表2 单一核型荧光模式EPA和人工判读方法判读的抗体滴度分布

表3 复合核型荧光模式主核型EPA和人工判读方法判读的抗体滴度分布

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EUROPattern全自动免疫核型及滴度判读系统检测抗核抗体的评价与合理应用

EUROPattern auto-reading system for the determination of anti-nuclear antibody

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