Laboratory screening of connective tissue diseases by a new automated ENA screening assay (EliA Symphony) in clinically defined patients
Laboratory screening of connective tissue diseases by a new automated ENA screening assay (EliA Symphony) in clinically defined patients
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DOI：
10.1016/j.cccn.2005.03.042
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发表时间：
2005-09-01
影响因子：
5
通讯作者：
González-Buitrago, JM
中科院分区：
文献类型：
--
作者：
González, C;García-Berrocal, B;González-Buitrago, JM
背景资料：抗核抗体（ANA）的测量在自身免疫实验室中用于结缔组织病（CTD）的筛查。ANA测量主要通过HEp-2细胞上的间接免疫荧光（1117）或通过酶免疫测定（EIA）进行。本研究的目的是临床评估的自动EIA可提取的核抗原（ENA），缺乏抗dsDNA的CTD的筛查。方法：这项研究共涉及170份血清样本，54例CTD患者，26例其他自身免疫性疾病的患者，90例非自身免疫性疾病。对于所有血清，ANA检测通过1117和EliATMSymphony（Pharmacia Diagnostics，弗赖堡，德国）进行，ENA筛选检测以下自身抗体：SSA/Ro、SS B/La、U1 RNP（70 kDa，A，C）Sc 1 -70、JO-1、着丝粒B和Sm。此外，对所有样品测量ami-dsDNA（EliA（TM）dsDNA，Pharmacia Diagnostics，弗赖堡，德国）。计算敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）、效率、阳性似然比（PLR）和阴性似然比（NLR）。IIF的诊断效率相似（82.6%）和EliA（TM）Symphony（82.3%），以及PLR（IIF为6.5，EliA（TM）Symphony为7.3）和NLR（IIF为0.35，EliA（TM）Symphony为0.41）。EliA（TM）Symphony和dsDNA的组合测量增加了灵敏度，但没有增加PLR。IIF（0.847）和EliA（TM）Symphony（0.823）的受试者工作特征（ROC）曲线下面积相似。结论：本研究的结果表明EliA（TM）Symphony单独或与抗dsDNA检测联合检测具有与HEp-2细胞1117相似的诊断CTD的效率，其截断值为1：160。(c)2005 Elsevier B. V.保留所有权利。
Background: The measurement of antinuclear antibodies (ANA) is used in the autoimmune laboratory for the screening of connective tissue diseases (CTD). ANA measurements are mainly performed by indirect immunofluorescence (1117) on HEp-2 cells or by enzyme immunoassay (EIA). The objective of this study was to clinically evaluate an automated EIA for extractable nuclear antigens (ENA) which lacks anti-dsDNA for the screening of CTD.Methods: The study involved a total of 170 serum samples, 54 from patients with CTD, 26 from patients with other autoimmune diseases, and 90 from patients with non-autoimmune diseases. For all sera, ANA detection was performed by 1117 and by EliA (TM) Symphony (Pharmacia Diagnostics, Freiburg, Germany), an ENA screening which detects the following autoantibodies: SSA/Ro, SSB/La, U1RNP (70 kDa, A, C,) Sc1-70, JO-1, centromere B and Sm. Also, ami-dsDNA (EliA (TM) dsDNA, Pharmacia Diagnostics, Freiburg, Germany) was measured on all samples. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), efficiency, positive likelihood ratio (PLR), and negative likelihood ratio (NLR) were calculated.Results: Diagnostic efficiency was similar for IIF (82.6%) and EliA (TM) Symphony (82.3%), as well as PLR (6.5 for IIF, and 7.3 for EliA (TM) Symphony), and NLR (0.35 for IIF, and 0.41 for EliA (TM) Symphony). The combined measurement of EliA (TM) Symphony and dsDNA increased sensitivity but not PLR. Area under receiver operator characteristic (ROC) curve was similar for IIF (0.847) and EliA (TM) Symphony (0.823).Conclusions: The results of the study demonstrate that EliA (TM) Symphony solely or combined with anti-dsDNA detection has an efficiency similar to HEp-2 cells 1117 with a cut-off of 1: 160 for the diagnosis of CTD. (c) 2005 Elsevier B.V. All rights reserved.