标题：纳米磁微粒化学发光法定量检测抗核抗体谱的临床应用

      作者：罗宇维，全树绿，张明娇    (南方医科大学第三附属医院风湿免疫科，广东 广州 510630)

      卷次： 2018年29卷11期

      【摘要】 目的 研究全自动、定量纳米磁微粒化学发光法(NM-CLIA)检测抗核抗体谱中10种自身抗体的临床应用价值，为抗核抗体谱检测方法的选择提供参考。方法 收集2016年10月至2018年2月南方医科大学第三附属医院自身免疫性疾病患者血清 1 037例，健康体检者血清 200例，用NM-CLIA检测血清抗干燥综合征抗原A60(SSA/Ro60)抗体、抗干燥综合征抗原A 52 (SSA/Ro52)抗体、抗干燥综合征抗原 B (SSB/La)抗体、抗双链DNA(ds-DNA)抗体、抗核糖核蛋白(RNP)抗体、抗史密斯(Sm)抗体、抗着丝点蛋白B (CENP-B)抗体、抗核糖体 P蛋白(Rib-P)抗体、抗核糖体(Nuc)抗体、抗组蛋白(His)抗体，同时应用线性免疫印迹法(LIA)平行检测以上抗核抗体谱，对检测结果进行统计学分析。结果 NM-CLIA在检测血清中10个常见自身抗体时具有较高特异性，均达95%以上；NM-CLIA与LIA对10个自身抗体具有相当的检出率，与文献报道的疾病抗体发生率一致；两种方法在检测抗SSA60抗体、抗SSA52抗体、抗SSB抗体、抗RNP抗体、抗CENPB抗体、抗Nuc抗体和抗His抗体时，表现出良好的一致性(Kappa>0.75，P<0.05)，而在检测抗 ds-DNA抗体、抗Sm抗体、抗Rib-p抗体时一致性一般(0.4P<0.05)；抗ds-DNA抗体、抗Sm抗体、抗Rib-p抗体在两种方法检测中结果不一致的样本经第三方试剂验证结果显示，NM-CLIA与第三方试剂在检测抗ds-DNA抗体、抗Sm抗体、抗Rib-p抗体时，差异无统计学意义(P>0.05）；LIA与第三方试剂检测结果比较差异均有统计学意义(P<0.05)。结论 NM-CLIA检测特定抗核抗体谱时具有良好的特异性及检出率，两种方法在检测抗SSA60抗体、抗SSA52抗体、抗SSB抗体、抗RNP抗体、抗CENPB抗体、抗Nuc抗体和抗His抗体时具有良好的一致性，而在检测抗 ds-DNA抗体、抗 Sm抗体、抗 Rib-p抗体时一致性一般，NM-CLIA与第三方试剂的检测结果更吻合。由于NM-CLIA具有全自动、简单、快速、定量、特异性好以及随机组合检测项目等优点，更值得临床推广应用。
      【关键词】 纳米磁微粒化学发光法；抗核抗体谱；线性免疫印迹法
      【中图分类号】 R446.1 【文献标识码】 A 【文章编号】 1003—6350（2018）11—1527—04

Clinical evaluation of magnetic nanoparticle chemiluminescence immunoassay in the detection of antinuclearantibody profile.
LUO Yu-wei, QUAN Shu-lv, ZHANG Ming-jiao. Department of Rheumatology and Immunology, theThird Affiliated Hospital of Southern Medical University, Guangzhou 510630, Guangdong, CHINA
【Abstract】 Objective To evaluate the clinical performance of an automated, quantitative magnetic nanoparti-cle chemiluminescence immunoassay (NM-CLIA) on detecting ten antinuclear antibodies profile. Methods A total of1 037 sera samples with autoimmune diseases and 200 healthy subjects were collected from the Third Affiliated Hospitalof Southern Medical University during the period of October 2016 to February 2018. The antibodies to SSA/60, SSA/52,SSB/La, double-stranded DNA (ds-DNA), ribonucleoprotein (rRNP), smith antigen (Sm), centromereprotein B(CENP-B), ribosome P protein (Rib-p), nucleosome (Nuc) and histone (His) were detected by NM-CLIA and line immu-noassay (LIA) in parallel. Results The specificity of NM-CLIA to ten autoanbodies was all above 95%. NM-CLIA andLIA have a comparable positive detection rate for 10 autoantibodies, which is consistent with the incidences of positiveantibodies of autoimmune diseases from reported data. NM-CLIA and LIA showed excellent qualitative coincidence ratein the detection of analyzing anti-SSA/60 antibodies, anti-SSA/52 antibodies, anti-SSB/La antibodies, anti-rRNP antibod-ies, anti-CENPB antibodies, anti-Nuc antibodies and anti-His antibodies (kappa>0.75, P<0.05), but the coincidence ratewas generally normal when detecting anti-ds-DNA antibodies, anti-Sm antibodies, and anti-Rib-p antibodies (0.4P<0.05). All the discrepant samples of the two methods were confirmed with the reagents from other manufac-turer. The results showed that there was no significant difference in the detection of anti-ds-DNA antibodies, anti-Sm an-tibodies, and anti-Rib-p antibodies between NM-CLIA and the validation reagent (P>0.05), but there was significant dif-ference between LIA and the validation reagent (P<0.05). Conclusion NM-CLIA showed excellent positive rate andspecificity when detecting ten antinuclear antibodies profile. The two methods show the excellent qualitative coincidencerate in the detection of anti-SSA/60 antibodies, anti-SSA/52 antibodies, anti-SSB/La antibodies, anti-rRNP antibodies,anti-CENPB antibodies, anti-Nuc antibodies and anti-His antibodies, but the coincidence rate is generally ordinary whendetecting anti-ds-DNA antibodies, anti-Sm antibodies, and anti-Rib-p antibodie. NM-CLIA test results have better consis-tency with the validation reagent among all discrepant samples. NM-CLIA has the advantages of full automatic, simple,fast, quantitative, high specificity and random combination detection items, which is more worthy of clinical applicationto to detect antinuclear antibodies profile.
      【Key words】 Magn