Shovman O, Gilburd B, Barzilai O, Shinar E, Larida B, Zandman-Goddard G, Binder S R, Shoenfeld Y
Department of Medicine "B" and Center for Autoimmune Diseases, Chaim Sheba Medical Center, Tel-Hashomer 52621, Israel.
Ann N Y Acad Sci. 2005 Jun;1050:380-8. doi: 10.1196/annals.1313.120.
The BioPlex 2200 ANA Screen is a fully automated system that determines levels for 13 different autoimmune antibodies of established clinical significance. The objective of this study was to determine the specificity of the BioPlex 2200 ANA Screen assay and to analyze the antibody profile samples collected from healthy subjects against comparative ELISA and IIF screening methods. A total of 510 specimens were randomly selected from a cohort of apparently healthy blood bank donors. Samples were distributed to five age brackets. All samples were tested using Bio-Rad's ANA Screen kit. Specificity was compared to IIF and ELISA results. Most of the samples were found negative in all ANA screening systems (84.5% by IIF, 92.5% by BioPlex 2200 ANA Screen kit, and 94.5% by ELISA). The frequency of positive results was highest (15.5%) using IIF, in comparison to almost similar results (5.5% vs. 7.5%) achieved by ANA ELISA and BioPlex 2200 ANA Screen kits. The positive rate of autoantibodies was significantly reduced when analyzed by different combinations of ANA screen assays (from 2.35% using IIF + BioPlex ANA Screen tests to 0.98% by using all three tests). Using the BioPlex 2200 ANA Screen system, we were able to identify samples with high levels of individual antibodies: anti-dsDNA at 20-63 IU/mL, antichromatin at 4-8 AI, anti-SmRNP at 2-6 AI, and anti-RNPA at 2-4.5 AI. Importantly, from 7 IIF and ELISA positive sera, 5 of these were also BioPlex 2200 positive, suggesting that the BioPlex is seeing the samples that are of the greatest interest, using the established techniques. The specificity of the BioPlex 2200 ANA Screen analysis of 13 different analytes (dsDNA, centromere B, chromatin, Jo1, ribosomal P, RNP 68, RNP A, Scl-70, Sm, SmPNP, SS-A52, SS-A60, SS-B) is comparable (P < 0.252) to the ELISA ANA screening test. Like the ELISA, the BioPlex 2200 has a lower (P < 0.001) positive rate than IIF for the autoantibody screening.
BioPlex 2200抗核抗体（ANA）筛查是一种全自动系统，可测定13种具有既定临床意义的不同自身免疫抗体的水平。本研究的目的是确定BioPlex 2200 ANA筛查检测的特异性，并针对比较酶联免疫吸附测定（ELISA）和间接免疫荧光法（IIF）筛查方法分析从健康受试者收集的抗体谱样本。从一组看似健康的血库献血者中随机选取了510份标本。样本被分为五个年龄组。所有样本均使用伯乐公司的ANA筛查试剂盒进行检测。将特异性与IIF和ELISA结果进行比较。在所有ANA筛查系统中，大多数样本被检测为阴性（IIF法为84.5%，BioPlex 2200 ANA筛查试剂盒法为92.5%，ELISA法为94.5%）。与ANA ELISA和BioPlex 2200 ANA筛查试剂盒获得的几乎相似的结果（5.5%对7.5%）相比，使用IIF法时阳性结果的频率最高（15.5%）。当通过ANA筛查检测的不同组合进行分析时，自身抗体的阳性率显著降低（从使用IIF + BioPlex ANA筛查检测时的2.35%降至使用所有三种检测时的0.98%）。使用BioPlex 2200 ANA筛查系统，我们能够识别出具有高水平个体抗体的样本：抗双链DNA（dsDNA）为20 - 63国际单位/毫升，抗染色质为4 - 8任意指数（AI），抗SmRNP为2 - 6 AI，抗核糖核蛋白A（RNPA）为2 - 4.5 AI。重要的是，在7份IIF和ELISA阳性血清中，其中5份也是BioPlex 2200阳性，这表明使用既定技术时，BioPlex能够检测到最受关注的样本。BioPlex 2200对13种不同分析物（dsDNA、着丝粒B、染色质、Jo1、核糖体P、核糖核蛋白68、核糖核蛋白A、Scl - 70、Sm、SmPNP、SS - A52、SS - A60、SS - B）的ANA筛查分析的特异性与ELISA ANA筛查检测相当（P < 0.252）。与ELISA一样，BioPlex 2200在自身抗体筛查中的阳性率低于IIF（P < 0.001）。
