The analysis to data from Chinese Rheumatism Data Center external quality assurance program for autoantibodies in 2021.
10.3760/cma.j.cn112150-20220713-00717
- Author:
Yi Na BAI
1
;
Chui Wen DENG
1
;
Ning SONG
1
;
Jin Li QIN
1
;
Meng Tao LI
1
;
Xiao Feng ZENG
1
;
Chao Jun HU
1
Author Information
1. Department of Rheumatology and Clinical Immunology, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases, Ministry of Science & Technology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing 100730, China.
- Publication Type:Journal Article
- MeSH:
Humans;
Autoantibodies;
Antibodies, Anticardiolipin/analysis*;
Retrospective Studies;
East Asian People;
beta 2-Glycoprotein I;
Rheumatic Diseases
- From:
Chinese Journal of Preventive Medicine
2022;56(12):1860-1867
- CountryChina
- Language:Chinese
-
Abstract:
To evaluate the data obtained from the external quality assurance program initiated by Chinese Rheumatism Data Center (CRDC-QAP) for autoantibodies detection in 2021, so as to assess the consensus and differences in cross-laboratory testing to autoantibodies in China. This is a retrospective study. After collecting data from the first half year (from May 15th to July 10th) and the second half year (from August 15th to November 19th) of CRDC-QAP program for autoantibody detection in 2021, it firstly analyzed the qualitative consensus of the cross-laboratory results. Secondly, it compared the positivity grade of numeric results according to the Sample to cut-off ratio (S/CO ratio) calculation. Finally, the mean and coefficient variation (CV) of numeric results from three major manufacturers were calculated. A total of 303 and 332 clinical labs voluntarily participated in the first half year and the second half year of CRDC-QAP program for autoantibody detection in 2021, respectively. Except for anti-β2 glycoprotein type I (aβ2-GPI) IgM, the cross-laboratory consensus of qualitative results for the other autoantibodies is greater than 96%. As for anti-cyclic citrullinated peptide antibody (anti-CCP) and anti mitochondrial antibody-M2 (AMA-M2), the numeric results from more than 90% laboratories showed the same positivity grade. More than 50% of laboratories used chemiluminescence immunoassay (CLIA) for quantitative evaluation of autoantibody. The CV of numeric results from different manufacturers showed certain differences(P<0.01) with the range from 0 to 238%. Although high consensus can be observed in term of qualitative result for autoantibody detection in cross-laboratory, there are still certain differences in numeric results in term of positivity grade and manufacturer-based CV.
