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比较法、3 种商业酶免疫分析法和克鲁利氏利什曼原虫免疫荧光试验在系统性红斑狼疮诊断和活动性评估中的应用。

Comparison of the Farr radioimmunoassay, 3 commercial enzyme immunoassays and Crithidia luciliae immunofluorescence test for diagnosis and activity assessment of systemic lupus erythematosus.

机构信息

Service de Médecine Interne, Centre National de Référence des Maladies Autoimmunes et Systémiques Rares (Sclérodermie), Centre Hospitalier Régional et Universitaire, Université Lille 2, Lille, France.

出版信息

Clin Chim Acta. 2010 Jul 4;411(13-14):959-64. doi: 10.1016/j.cca.2010.03.016. Epub 2010 Mar 19.

Abstract

BACKGROUNDS

Among anti-double-strand (ds)DNA antibody assays, Farr radioimmunoassay is decreasingly used because it requires radioactive material and is labor intensive. We evaluated the performance of Farr, three commercial enzyme immunoassays (EIAs) and the Crithidia luciliae immunofluorescence test (CLIFT) in systemic lupus erythematosus (SLE).

METHODS

Anti-dsDNA antibodies were determined in 99 SLE patients, 101 healthy subjects, and 53 patients with autoimmune rheumatic diseases.

RESULTS

Farr performed better than the 3 EIAs and CLIFT for the diagnosis of SLE at the manufacturer's cut off and at the cut off set to achieve a specificity of 95%. To achieve a similar level of specificity, some EIAs had a decrease in sensitivity which was dramatic for some tests. Farr was also the best at distinguishing patients with quiescent to mildly active disease from patients with more active disease at the cut off value of 93 IU/ml. Using manufacturer's cut off did not allow distinguishing between patients with quiescent and active SLE.

CONCLUSIONS

Farr was the best global test to assess the level of anti-dsDNA antibodies for both diagnosis and disease activity evaluation in SLE with adequately determined cut off values. Some EIA had low performances limiting their use in decision-making regarding diagnosis and/or treatment.

摘要

背景

在抗双链 (ds)DNA 抗体检测中,由于 Farr 放射免疫测定法需要放射性物质且劳动强度大,因此其应用逐渐减少。我们评估了 Farr、三种商业酶免疫测定法 (EIA) 和克氏锥虫免疫荧光试验 (CLIFT) 在系统性红斑狼疮 (SLE) 中的性能。

方法

在 99 例 SLE 患者、101 例健康对照者和 53 例自身免疫性风湿病患者中测定抗 dsDNA 抗体。

结果

Farr 在制造商设定的截断值和为达到 95%特异性而设定的截断值下,对 SLE 的诊断优于 3 种 EIA 和 CLIFT。为了达到类似的特异性水平,一些 EIA 的敏感性下降,对某些检测而言,这种下降非常显著。在 93 IU/ml 的截断值下,Farr 还最能区分病情稳定至轻度活动的患者与病情更活跃的患者。使用制造商设定的截断值无法区分病情稳定和活动期 SLE 患者。

结论

Farr 是评估 SLE 患者抗 dsDNA 抗体水平的最佳综合检测方法,无论是在诊断还是疾病活动评估方面,都具有足够确定的截断值。某些 EIA 的性能较低,限制了其在诊断和/或治疗决策中的应用。

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