OBJECTIVE:Replacement of standard immunofluorescence methods with bead-based assays for antinuclear antibody (ANA) testing is a new clinical option. The aim of this study was to evaluate a large, multiethnic cohort of patients with systemic lupus erythematosus (SLE), blood relatives, and unaffected control individuals for familial aggregation and subset clustering of autoantibodies by high-throughput serum screening technology and traditional methods. METHODS:Serum samples (1,540 SLE patients, 1,154 unaffected relatives, and 906 healthy, population-based controls) were analyzed for SLE autoantibodies using a bead-based assay, indirect immunofluorescence (IIF), and immunodiffusion. Autoantibody prevalence, sensitivity for disease detection, clustering of autoantibodies, and associations between newer methods and standard immunodiffusion results were evaluated. RESULTS:The frequencies of ANAs in the sera from African American, Hispanic, and European American patients with SLE were 89%, 73%, and 67%, respectively, by BioPlex 2200 bead-based assay and 94%, 84%, and 86%, respectively, by IIF. When comparing the serum prevalence of 60-kd Ro, La, Sm, nuclear RNP A, and ribosomal P autoantibodies across assays, the sensitivity of detection ranged from 0.92 to 0.83 and the specificity ranged from 0.90 to 0.79. Autoantibody cluster analysis showed associations of autoantibody specificities in 3 subsets: 1) 60 kd Ro, 52-kd Ro, and La, 2) spliceosomal proteins, and 3) double-stranded DNA (dsDNA), chromatin, and ribosomal P. Familial aggregation of Sm/RNP, ribosomal P, and 60-kd Ro in SLE patient sibling pairs was observed (P ≤ 0.004). Simplex-pedigree SLE patients had a greater prevalence of dsDNA (P = 0.0003) and chromatin (P = 0.005) autoantibodies compared to patients with a multiplex SLE pedigree. CONCLUSION:The frequencies of ANAs detected by a bead-based assay are lower than those detected by IIF in European American patients with SLE. These assays have strong positive predictive values across ethnic groups, provide useful information for clinical care, and provide unique insights into familial aggregation and autoantibody clustering.

译文

目的:用基于微珠的抗核抗体(ANA)检测方法代替标准的免疫荧光方法是一种新的临床选择。这项研究的目的是通过高通量血清筛查技术和传统方法评估系统性红斑狼疮(SLE)患者,血亲和未受影响对照个体的大型,多种族队列,以进行家族聚集和自身抗体的子集聚。
方法:使用基于珠的检测,间接免疫荧光(IIF)和免疫扩散分析血清样本(1,540名SLE患者,1,154名未受影响的亲戚和906名健康的,基于人群的对照)的SLE自身抗体。自身抗体的流行率,疾病检测的敏感性,自身抗体的聚类,以及新方法和标准免疫扩散结果之间的关联进行了评估。
结果:通过BioPlex 2200珠基检测法,非裔,西班牙裔和欧洲裔SLE患者血清中的ANA频率分别为89%,73%和67%,分别为94%,84%和86 IIF分别为%。在整个试验中比较血清中60 kd Ro,La,Sm,核RNP A和核糖体P自身抗体的患病率时,检测的灵敏度为0.92至0.83,特异性为0.90至0.79。自身抗体簇分析显示了3个子集中的自身抗体特异性的关联:1)60 kd Ro,52 kd Ro和La,2)剪接体蛋白和3)双链DNA(dsDNA),染色质和核糖体P.家族聚集观察到SLE患者同胞对中Sm / RNP,核糖体P和60 kd Ro的变化(P≤0.004)。与具有多重SLE谱系的患者相比,单纯谱系SLE患者的dsDNA(P = 0.0003)和染色质(P = 0.005)自身抗体的患病率更高。
结论:在美国SLE患者中,基于微珠的检测方法检测到的ANAs频率低于IIF检测的频率。这些测定法在各个族裔中都具有很强的阳性预测价值,可为临床护理提供有用的信息,并提供有关家族聚集和自身抗体聚类的独特见解。

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