【Abstract】To standardize the application of biomarkers in the diagnosis, treatment, and prognostic monitoring of systemic and organ-specific autoimmune diseases, the Autoimmunity Branch of the Chinese Society of Immunology organized a panel of experts to develop the consensus on the clinical application of biomarker detection in autoimmune diseases. This consensus was developed by adopting the GRADE system for evidence quality assessment and recommendation grading, with best clinical practice statements incorporated. It consists of 4 general principles-including prioritizing the biomarkers and assay methods recommended by domestic and international consensus documents, multidisciplinary joint interpretation when test results are inconsistent with clinical features, and prudent, patient-tailored use of novel biomarkers-as well as 15 recommendations that propose standardized testing protocols for the relevant specific biomarkers across various autoimmune diseases, so as to provide scientific and practical guidance for clinical biomarker testing.

1.生物标志物检测可作为自身免疫病诊断、鉴别诊断、治疗监测和预后评估的参考指标。疾病分类（诊断）标准及国内国际专家共识列出的生物标志物优先检测（最佳临床实践陈述）。

推荐意见1：ANA是SLE和SS等自身免疫病的重要检测项目。建议以HEp-2细胞为底物的间接免疫荧光法（indirect immunofluorescence，IIF）法为首选检测方法，检测报告中注明检测方法、定性结果、抗体滴度和荧光核型（证据等级：1；推荐强度：强）。