抗双链 DNA IgG 抗体检测在系统性红斑狼疮诊断中的分析一致性存在显著差异--对实验室间检测的影响。

Significant differences in the analytic concordance between anti-dsDNA IgG antibody assays for the diagnosis of systemic lupus erythematosus--implications for inter-laboratory testing.

机构信息

Associated Regional and University Pathologists (ARUP) Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108-1221, United States.

出版信息

Clin Chim Acta. 2011 May 12;412(11-12):1076-80. doi: 10.1016/j.cca.2011.02.025. Epub 2011 Feb 23.

DOI:10.1016/j.cca.2011.02.025

PMID:21352819

Abstract

BACKGROUND

Anti-double stranded DNA (anti-dsDNA) autoantibodies are considered hallmark of systemic lupus erythematosus (SLE).

METHODS

To determine concordance between assays for the detection of this marker, we analyzed 100 antinuclear antibody (ANA) positive sera with a homogeneous pattern and titers≥1:160 by indirect immunofluorescence assay (IFA) on HEp-2 cells, 100 consecutive anti-dsDNA IgG ELISA-negative as well as 100 healthy control samples using six commercial ELISAs and the Crithidia luciliae immunofluorescence test (CLIFT).

RESULTS

The positivity rates for the ELISAs in the ANA positive group ranged from 55.0 to 88.0% with specificities from 84.0 to 98.0%. The CLIFT had a positivity rate of 68.0% and specificity of 84%. In the previously screened anti-dsDNA IgG-negative group, the positivity rates ranged from 1 to 19%. The overall correlations between the ELISAs ranged from 73.0 to 89.5% and varied from 70.0 to 80.0% among specific ELISAs and CLIFT.

CONCLUSIONS

Our data show variable degree of concordance between anti-dsDNA IgG ELISAs which may significantly impact inter-laboratory testing as well as the diagnosis and management of SLE patients. Although some of the ELISAs show comparable performance to the CLIFT, the degree of concordance between these assays at high antibody levels suggests that CLIFT is still a relevant confirmatory tool.

摘要

背景

抗双链 DNA（抗 dsDNA）自身抗体被认为是系统性红斑狼疮（SLE）的标志性特征。

方法

为了确定检测该标志物的检测方法之间的一致性，我们使用 6 种商业 ELISA 和克鲁氏锥虫免疫荧光试验（CLIFT）分析了 100 份具有均一模式和滴度≥1:160 的间接免疫荧光法（IFA）阳性的抗核抗体（ANA）阳性血清，100 份连续抗 dsDNA IgG ELISA 阴性和 100 份健康对照样本。

结果

在 ANA 阳性组中，ELISA 的阳性率为 55.0%至 88.0%，特异性为 84.0%至 98.0%。CLIFT 的阳性率为 68.0%，特异性为 84.0%。在先前筛选的抗 dsDNA IgG 阴性组中，阳性率为 1%至 19%。ELISA 之间的总体相关性为 73.0%至 89.5%，特异性 ELISA 和 CLIFT 之间的相关性为 70.0%至 80.0%。