摘要
目的研究全自动、全定量和随机上样的化学发光法(CLIA)在针对抗可提取核抗原抗体(antiENA)检测结果在结缔组织病(CTD)的临床诊断价值,为临床实验室检测anti-ENA的方法学选择提供参考。方法同时利用CLIA、免疫斑点法(ID)和多重流式免疫分析法(MFI)对323例CTD患者、123例非结缔组织病组(Non-CTD)及70例健康对照组(NCs)开展针对抗核糖核蛋白/史密斯(RNP/Sm)抗体、抗史密斯(Sm)抗体、抗干燥综合征抗原A(SSA/Ro60)抗体、抗干燥综合征抗原B(SSB/La)抗体、抗组氨酰tRNA合成酶(Jo-1)抗体、抗硬皮病70(Scl-70)抗体和抗核糖体P蛋白(Rib-P)抗体的平行检测;分析CTD患者各抗体与ID和MFI检测结果一致性。使用ELISA方法就比对不同方法学差异样本进行复测验证。结果在NCs组中,CLIA法检测anti-ENA的阳性检出率均低于2%;在Non-CTD组中,各抗体阳性检出率均低于10%。在CTD中,CLIA分别与ID和MFI开展方法学比对分析。与ID相比,除抗SS-A抗体(71.21%)外,其他抗体一致性均大于85%;与MFI相比,除抗SSB抗体(69.66%)和抗Sm抗体(73.07%)外,其他抗体一致性均大于75%。针对抗Sm抗体,不同方法学差异样本进行ELISA方法学的重复验证,以其结果作为参考依据,再次开展一致性分析,总体一致性分别提升至96.28%;CLIA及MFI诊断效能分析中,抗Sm抗体的曲线下(AUC)面积分别为0.516 3及0.814 9,抗SSB抗体AUC面积分别为0.738 0及0.747 0。结论与ID和MFI相比较,CLIA在NCs中检测anti-ENA时具有最好的检测特异度,且与上述两种检测方法在CTD中的检测结果具有较好的一致性和符合率。由于不同检测方法在检测anti-ENA时灵敏度及特异度均存在一定差异,未来实验室方法学的选择时,应结合样本的临床诊断信息及方法学的具体特点(包括自动化程度、检测线性范围、样本随机上样和检测项目灵活组合)等方面综合判断。
Objective To evaluate the clinical performance of an automated, quantitative and random-ac cessed Chemiluminescent Immunoassay （CLIA） on testing of anti-extractable nuclear antigen antibody （anti- ENA）. Methods Sera from patients who suffered from connective tissue disease （CTD,n=323） and diseases other than CTD （Non-CTD,n=123） together with sera from normal controls （NCs,n=70） were collected and tested with CI.IA, Immuno-Dot （ID） and Multiplex Flow Immunoassay （MFI） in parallel for antibodies to ri- bonucleoprotein/smith antigen （ RNP/Sm）, smith antigen （ Sin）, SSA/Ro60, SSB/La, Scl-70, Jo-1 and ribo- some P protein（Rib-P）. The qualitative agreement between CLIA and other two assays were analyzed sepa rately. Discrepant samples between CLIA and other two assays were retested with Enzyme Linked Immu- nosorbent Assay （ELISA）. Results The positive rate for each antibody tested by CI.IA in PEI and Non-CTD were lower than 5 % and 10 % respectively. In CTD cohort, the total agreement between CLIA and ID for each antibody was higher than 85.0% except anti-SSA/Ro60 （71.21%）,while the total agreement between CLIA and MFI was greater than 75.0% with the exception of anti-SSB（69. 66%）and anti-Sin（73.07%）. After all discrepant samples between CLIA and ID were confirmed by EI.ISA, the total agreement for anti-SSA/Ro60 were raised to 96.28 %. The diagnostic efficacy analysis in CLIA and MFI, the AUC area of anti SM antibody was 0. 516 3 and 0. 814 9,respectively,and the AUC area of anti SSB antibody AUC was 0. 238 0 and 0. 747 0 respectively. Conclusion CLIA shows the best specificity in PEI cohort together with a comparable total a- greement in CTD cohort,when comparing with ID and MFI for the detecting of anti-ENA. Since different as- says may yield different sensitivity and specificity, it is strongly recommended for a laboratory to perform a comprehensive comparison based on clinical information and assay features （including output and random-access）,when choosin
作者
李静
刘国娣
王楷文
胡德宇
赵江峰
LI Ying;LIU Guodi;WANG Kaiwen;HU Deyu;ZHAO Jiangfeng(Department of Clinical Laboratory ,Shanghai First Maternal and In fant Hospital, Tongji University School of Medicine ,Shanghai 201204 ,China;Department of Clinical Laboratory, Second People＇s Hospital of Yangzhou ,Yang-zhou ,Jiansu 225007 ,China;Department of Rheumatology,Renji Hospital South Campus ,Shanghai Jiaotong Universit School of Medicine, Shanghai 201112, China;Department of Clinical Laboratory, International Peace Maternity and Child Health Hospital ,Shang-hai Jiaotong University ,School of Medicine ,Shanghai 200030 ,China)
出处
《国际检验医学杂志》
CAS
2018年第19期2402-2407,共6页
International Journal of Laboratory Medicine
