Expert consensus on the clinical application of anti-dsDNA antibodies in systemic lupus erythematosus

doi:10.3969/j.issn.1673-8640.2026.03.001

Abstract

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

CLC Number:

R446.62

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.

Figures/Tables 4

References 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