三种不同方法学检测抗核抗体谱的结果分析与评价-东南大学学报医学版

三种不同方法学检测抗核抗体谱的结果分析与评价

单位：南京大学医学院附属鼓楼医院医学检验科, 江苏南京 210008

分类号：R593.2;R446.11

出版年·卷·期（页码）：2025·44·第二期（189-196）

摘要：

目的:比较免疫印迹法、磁条码免疫荧光发光法和化学发光法这3种不同方法学检测抗核抗体谱的结果差异,评估各方法的优势和诊断性能。方法:收集100例自身免疫性疾病(AID)患者和30例健康对照人群的血清样本,采用3种方法对样本进行抗核抗体谱检测。分析3种方法检测结果的阳性率、阳性符合率、阴性符合率及一致性。结果:免疫印迹法、磁条码免疫荧光发光法和化学发光法检测AID的阳性率分别为82.0%、72.0%、77.0%,各方法检测阳性率差异无统计学意义(P=0.244)。免疫印迹法与磁条码免疫荧光发光法的总符合率范围为81.1%~100%,免疫印迹法与化学发光法之间的总符合率范围为81.4%~100%,磁条码免疫荧光发光法与化学发光法之间的总符合率范围为63.6%~100%。3种方法对抗SSA抗体、抗Ro52抗体、抗SSB抗体、抗CENP-B抗体、抗Scl-70抗体这5种抗体的检测结果一致性较高(kappa>0.75)。而在对照组中,免疫印迹法检测抗ds-DNA抗体阳性率达到6.7%;化学发光法检测抗His抗体的阳性率达到23.3%,假阳率偏高;而磁条码免疫荧光法在对照组中所有抗体阳性检出率均较低。结论:3种方法对抗核抗体谱的检测结果具有较高的一致性,均适用于临床。总之,抗核抗体检测的标准化仍然面临诸多挑战,可根据患者自身情况选择,必要时多种方法进行验证,避免误诊与漏诊。

Objective: To compare the results of three different methods immunoblotting, magnetic barcode immunofluorescence, and chemiluminescence for detecting antinuclear antibody profiles, and to evaluate their advantages and diagnostic performance. Methods: Serum samples from 100 patients with autoimmune disease(AID) and 30 healthy controls were collected, and three detection methods were used to detect the anti-nuclear antibody spectrum. The positive rate, positive coincidence rate, negative coincidence rate and consistency of the three methods were analyzed. Results: The positive rates of immunoblotting, magnetic bar code immunofluorescent luminescence and chemiluminescence in AID group were 82.0%, 72.0% and 77.0%, respectively, and there was no significant difference in the positive rates of all methods(P=0.244). The total coincidence rate between immunoblotting and magnetic bar code immunofluorescent luminescence method was 81.1% to 100%, and between immunoblotting and chemiluminescence method was 81.4% to 100%, while the total coincidence rate between magnetic bar code immunofluorescent luminescence method and chemiluminescence method was 63.6% to 100%. The results of the three methods for the detection of anti-SSA,anti-Ro52,anti-SSB,anti-CENP-B,anti-Scl70 were consistent(kappa>0.75). In the control group, the positive rate of anti-DS-DNA antibody detected by immunoblotting was 6.7%. The positive rate of anti-His antibody detected by chemiluminescence was 23.3%, and the false positive rate was high. The positive detection rate of all antibodies in the control group was lower by magnetic bar code immunofluorescence. Conclusion: The results of the three methods have high consistency and are suitable for clinical use. In conclusion, the standardization of antinuclear antibodies detection still faces many challenges. If necessary, a variety of verification methods can be selected according to the patient's own situation to avoid misdiagnosis and missed diagnosis.

参考文献：

[1] MILLER F W.The increasing prevalence of autoimmunity and autoimmune diseases:an urgent call to action for improved understanding,diagnosis,treatment,and prevention[J].Curr Opin Immunol,2023,80:102266.
[2] HAYTER S M,COOK M C.Updated assessment of the prevalence,spectrum and case definition of autoimmune disease[J].Autoimmun Rev,2012,11(10):754-765.
[3] 钱嘉航,任军,贾凌云,等.自身免疫性疾病与自身抗体概述[J].中国免疫学杂志,2022,38(17):2152-2158.
[4] 中国医师协会风湿免疫科医师分会自身抗体检测专业委员会.抗核抗体检测的临床应用专家共识[J].中华检验医学杂志,2018,41(4):275-280.
[5] DAMOISEAUX J,VON MUHLEN C A,GARCIA-DE LA TORRE I,et al.International consensus on ANA patterns(ICAP):the bumpy road towards a consensus on reporting ANA results[J].Auto Immun Highlights,2016,7(1):1.
[6] LOPEZ-LONGO F J,RODRIGUEZ-MAHOU M,ESCALONA-MONGE M,et al.Simultaneous identification of various antinuclear antibodies using an automated multiparameter line immunoassay system[J].Lupus,2003,12(8):623-629.
[7] SATOH M,TANAKA S,CHAN E K.The uses and misuses of multiplex autoantibody assays in systemic autoimmune rheumatic diseases[J].Front Immunol,2015,6:181.
[8] 李静,刘国娣,王楷文,等.化学发光法检测抗可提取核抗原抗体的临床应用研究[J].国际检验医学杂志,2018,39(19):2402-2407.
[9] SACK U,BOSSUYT X,ANDREEVA H,et al.Quality and best practice in medical laboratories:specific requests for autoimmunity testing[J].Auto Immun Highlights,2020,11(1):12.
[10] 罗春华,郝杏飞,柳邦源,等.全自动免疫分析仪在检测SLE相关自身抗体中的应用价值[J].中国设备工程,2024(10):244-246.
[11] 武建国.SLE和类风湿关节炎的新分类标准[J].临床检验杂志,2013,31(7):481-483.
[12] VITALI C,BOMBARDIERI S,JONSSON R,et al.Classification criteria for Sjogren's syndrome:a revised version of the European criteria proposed by the American-European Consensus Group[J].Ann Rheum Dis,2002,61(6):554-558.
[13] 高文琴,张改连,张莉芸,等.系统性硬化病两种分类标准诊断价值的评估[J].中国药物与临床,2020,20(21):3544-3547.
[14] TANAKA Y,KUWANA M,FUJII T,et al.2019 Diagnostic criteria for mixed connective tissue disease(MCTD):From the Japan research committee of the ministry of health,labor,and welfare for systemic autoimmune diseases[J].Mod Rheumatol,2021,31(1):29-33.
[15] DUMAS G,ARABI Y M,BARTZ R,et al.Diagnosis and management of autoimmune diseases in the ICU[J].Intensive Care Med,2024,50(1):17-35.
[16] BOSSUYT X,DE LANGHE E,BORGHI M O,et al.Understanding and interpreting antinuclear antibody tests in systemic rheumatic diseases[J].Nat Rev Rheumatol,2020,16(12):715-726.
[17] 李朝贵,马松涛.抗核抗体和抗核抗体谱联合检测应用于自身免疫性疾病的诊断价值分析[J].家庭医药,2018(2):6.
[18] DAMOISEAUX J,ANDRADE L E C,CARBALLO O G,et al.Clinical relevance of HEp-2 indirect immunofluorescent patterns:the International Consensus on ANA patterns(ICAP) perspective[J].Ann Rheum Dis,2019,78(7):879-889.

服务与反馈：

【文章下载】【发表评论】【查看评论】【加入收藏】

提示：您还未登录，请登录！点此登录