系统性红斑狼疮抗dsDNA抗体临床应用专家共识

doi:10.3969/j.issn.1673-8640.2026.03.001

摘要/Abstract

摘要：

系统性红斑狼疮（SLE）是一种高度异质性的系统性自身免疫性疾病，外周血抗核抗体（ANA）阳性是其典型特征，有95%以上的SLE患者ANA呈阳性。针对不同的自身抗原，ANA又可细分为多种抗体，其中抗双链DNA（dsDNA）抗体是SLE的特异性抗体，是疾病诊断、病情监测和治疗应答评估的重要血清学标志物之一。然而，抗dsDNA抗体检测方法较多，受方法学的多样性、商品化试剂盒的差异、参考物质缺乏、校准品和溯源标准化不足、检测线性范围和临界值不同等的影响，不同医疗机构之间抗dsDNA抗体检测结果的可比性、一致性较低，检验结果互认出现障碍，导致不同医疗机构对抗dsDNA抗体结果的解读存在一定分歧，并产生了疾病诊断存在不确定性、病情监测无统一标准等问题。上海市临床检验质量控制中心、上海市风湿免疫科临床质量控制中心和上海市免疫学会在充分参考国内外循证医学证据和专家建议的基础上，结合国内临床实践现状，制定《系统性红斑狼疮抗dsDNA抗体临床应用专家共识》，从抗dsDNA抗体在SLE中的临床应用价值、检测方法比较和应用、参考物质建立和性能验证等方面进行详细阐述，旨在为抗dsDNA抗体检测和结果解读提供循证依据和实践参考。

关键词: 抗双链DNA抗体, 抗核抗体, 系统性红斑狼疮, 临床应用, 专家共识

Abstract:

Systemic lupus erythematosus（SLE）is a highly heterogeneous systemic autoimmune disease，with positive anti-nuclear antibodies（ANA）in peripheral blood being a typical feature. Over 95% of SLE patients have positive ANA. ANA can be further classified into various antibodies based on different autoantigens，among which anti-double-stranded DNA（dsDNA）antibodies are specific to SLE and are one of the important serological markers for disease diagnosis，disease monitoring and treatment response assessment. However，there are many methods used for the determination of anti-dsDNA antibodies. Due to the diversity of methodologies，differences in commercial kits，lack of reference materials，insufficient standardization of calibrators and traceability，and variations in determination linear ranges and cut-off values，the comparability and consistency of anti-dsDNA antibody determination results among different medical institutions are relatively low. This has led to obstacles in mutual recognition of determination results and caused certain differences in the interpretation of anti-dsDNA antibody determination results in different medical institutions，resulting in uncertainties in disease diagnosis and the lack of a unified standard for disease monitoring. Shanghai Center for Clinical Laboratory Quality Control，Shanghai Center for Rheumatology and Immunology Clinical Quality Control and Shanghai Immunology Association，based on a thorough review of domestic and international evidence-based medical evidence and expert opinions，and in consideration of the current domestic clinical practice situation，have formulated the "Expert Consensus on the Clinical Application of Anti-dsDNA Antibodies in Systemic Lupus Erythematosus". This expert consensus provides detailed elaboration on the clinical application value of anti-dsDNA antibodies in SLE，comparisons and applications of determination methods，establishment and performance verification of reference materials and so on，offering evidence-based guidance and practical references for the determination and interpretation of anti-dsDNA antibodies in SLE patients.

Key words: Anti-double-stranded DNA antibody, Anti-nuclear antibody, Systemic lupus erythematosus, Clinical application, Expert consensus

中图分类号:

R446.62

上海市临床检验质量控制中心, 上海市风湿免疫科临床质量控制中心, 上海市免疫学会. 系统性红斑狼疮抗dsDNA抗体临床应用专家共识[J]. 检验医学, 2026, 41(3): 205-216.

Shanghai Center for Clinical Laboratory Quality Control, Shanghai Center for Rheumatology and Immunology Clinical Quality Control, Shanghai Immunology Association. Expert consensus on the clinical application of anti-dsDNA antibodies in systemic lupus erythematosus[J]. Laboratory Medicine, 2026, 41(3): 205-216.

图/表 4

参考文献 63

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项目	分级	内容
证据质量	高（A）	非常有把握：观察值接近真实值
	中（B）	对观察值有中等把握：观察值有可能接近真实值，但亦有可能差别很大
	低（C）	对观察值的把握有限：观察值与真实值可能有很大差别
	极低（D）	对观察值几乎无把握：观察值与真实值可能有极大差别
推荐强度	强（1）	明确显示干预措施利大于弊或弊大于利
	弱（2）	利弊不确定或无论质量高低的证据均显示利弊相当

项目	分级	内容
证据质量	高（A）	非常有把握：观察值接近真实值
	中（B）	对观察值有中等把握：观察值有可能接近真实值，但亦有可能差别很大
	低（C）	对观察值的把握有限：观察值与真实值可能有很大差别
	极低（D）	对观察值几乎无把握：观察值与真实值可能有极大差别
推荐强度	强（1）	明确显示干预措施利大于弊或弊大于利
	弱（2）	利弊不确定或无论质量高低的证据均显示利弊相当

方法	亚型	特异性/%	敏感性/%
RIA	IgG、IgM	53.0~100.0	26.7~93.0
	IgG	96.1	31.6
	IgG、IgM、IgA	89.0	95.0
FEIA	IgG	91.0~99.0	17.0~95.0
CLIFT	IgG	91.0~100.0	48.0~92.8
ELISA	IgG	70.7~96.0	26.2~82.6
	高亲合力IgG	90.2~96.5	60.6~82.7
	IgG，IgM	86.8~95.3	33.3~84.6
多重免疫分析法	IgG	88.0~98.0	21.3~70.0
CLIA	IgG	70.7~97.7	20.0~86.6
LIA	IgG	92.0	62.0~79.6

方法	亚型	特异性/%	敏感性/%
RIA	IgG、IgM	53.0~100.0	26.7~93.0
	IgG	96.1	31.6
	IgG、IgM、IgA	89.0	95.0
FEIA	IgG	91.0~99.0	17.0~95.0
CLIFT	IgG	91.0~100.0	48.0~92.8
ELISA	IgG	70.7~96.0	26.2~82.6
	高亲合力IgG	90.2~96.5	60.6~82.7
	IgG，IgM	86.8~95.3	33.3~84.6
多重免疫分析法	IgG	88.0~98.0	21.3~70.0
CLIA	IgG	70.7~97.7	20.0~86.6
LIA	IgG	92.0	62.0~79.6

方法	RIA	CLIFT	ELISA	CLIA	LIA
CLIFT	0.378~0.556
ELISA	0.683~0.707	0.411~0.639
CLIA	0.549	0.550~0.630	0.580~0.794
LIA	0.251	0.522~0.637	0.278~0.414	0.549~0.720
多重免疫分析法		0.490~0.540	0.680	0.420~0.610	0.403~0.530