Challenges for consistency and quality control of autoantibody assays and strategies for quality improvement
10.3760/cma.j.cn114452-20250225-00107
- VernacularTitle:自身抗体检测的一致性与质量控制的挑战及改进策略
- Author:
Yudong LIU
1
Author Information
1. 北京医院 国家老年医学中心，国家卫生健康委临床检验中心，中国医学科学院老年医学研究院，北京100730
- Publication Type:Journal Article
- Keywords:
Autoantibodies;
Quality assessment;
Quality improvement;
External quality assessment
- From:
Chinese Journal of Laboratory Medicine
2025;48(4):446-452
- CountryChina
- Language:Chinese
-
Abstract:
Autoantibody immunoassays are critical in the diagnosis, disease stratification and prognosis of autoimmune disease (AID). Many important autoantibodies have been included in the diagnostic criteria for the classification and stratification of AID. However, the poor comparability among different methodologies may lead to significant differences in the interpretation of autoantibody test results, which poses a great challenge for the clinical application of autoantibody testing. The aim of this article is to discuss the main factors affecting the comparability of autoantibody test results, including the heterogeneity of autoantibodies, the variability of antigens, the setting of the positive judgment value for qualitative tests, and the traceability of calibrators for quantitative tests. In addition, this article also discusses the role of external quality assessment in improving the comparability of autoantibody test results.
