Bossuyt X
Department of Laboratory Medicine, University Hospital Leuven, Belgium.
Clin Chem Lab Med. 2000 Oct;38(10):1033-7. doi: 10.1515/CCLM.2000.153.
We evaluated two enzyme immunoassays (EIA) for detection of antinuclear antibodies (ANA) which became recently available and which were designed for application on a fully automated system; (i) the EIA-ANA screen kit from Sigma Diagnostics (St. Louis, MO, USA) applied on APTUS, an automated EIA analyser from Sigma Diagnostics and (ii) the Cobas Core Hep-2 EIA-ANA assay applied on the fully automated Cobas Core immunochemistry analyzer from Roche Diagnostics (Basel, Switzerland). The evaluation was done by an analytic comparison of the automated systems to an established indirect immunofluorescence (IF) method performed on SSA transfected human epitheloid cell substrate slides. Three hundred and thirty six samples were tested with the Sigma EIA-ANA assay and 603 samples with the Cobas Core Hep-2 EIA-ANA assay. For both EIA systems, there was a trend of generally increasing signal from the assay system with increasing IF-ANA titers. With an IF-ANA reference range of < 1:160, concordance between Sigma EIA-ANA and IF-ANA was 86% and concordance between Roche EIA-ANA and IF-ANA was 85%. When compared to IF-ANA with a reference range of < 1:160, sensitivity and specificity of the EIA-ANA screen was 0.65 and 0.92, respectively, for Sigma EIA-ANA and 0.61 and 0.91, respectively, for the Cobas Core assay. The low sensitivity observed with both methods is a major concern. Sigma EIA-ANA screen revealed the presence of autoantibodies in 23 of the 29 samples containing antibodies to extractable nuclear antigens (ENA) and/or double stranded DNA and the Cobas Core Hep-2 EIA-ANA assay revealed the presence of autoantibodies in 40 of the 43 samples containing antibodies to ENA and/or double stranded DNA.
我们评估了两种用于检测抗核抗体（ANA）的酶免疫测定法（EIA），这两种方法最近才面市，且设计用于全自动系统；（i）美国密苏里州圣路易斯市西格玛诊断公司的EIA - ANA筛查试剂盒，应用于该公司的APTUS全自动EIA分析仪；（ii）罗氏诊断公司（瑞士巴塞尔）的Cobas Core Hep - 2 EIA - ANA测定法，应用于全自动的Cobas Core免疫化学分析仪。通过将这些自动化系统与在经SSA转染的人上皮样细胞底物载玻片上进行的既定间接免疫荧光（IF）方法进行分析比较来完成评估。用西格玛EIA - ANA测定法检测了336个样本，用Cobas Core Hep - 2 EIA - ANA测定法检测了603个样本。对于这两种EIA系统，随着IF - ANA滴度增加，测定系统的信号总体上有增加的趋势。IF - ANA参考范围<1:160时，西格玛EIA - ANA与IF - ANA的一致性为86%，罗氏EIA - ANA与IF - ANA的一致性为85%。与参考范围<1:160的IF - ANA相比，西格玛EIA - ANA筛查的灵敏度和特异性分别为0.65和0.92，Cobas Core测定法的灵敏度和特异性分别为0.61和0.91。两种方法观察到的低灵敏度是一个主要问题。西格玛EIA - ANA筛查在29个含有可提取核抗原（ENA）和/或双链DNA抗体的样本中的23个中检测到自身抗体，Cobas Core Hep - 2 EIA - ANA测定法在43个含有ENA和/或双链DNA抗体的样本中的40个中检测到自身抗体。
