中华临床免疫和变态反应杂志2016，Vol.10Issue(1)：28-32,5.DOI:10.3969/j.issn.1673-8705.2016.01.006
2013年全国116家实验室抗磷脂抗体检测比对分析
Comparison Analyses of the Detection of Anti-phospholipid Antibodies in 116 Laboratories across the Country in 2013
摘要
Abstract
Objective To study the current situations anti-phospholipid antibodies in China,identifying the issues in order to improve and enhance its detection quality.Methods Preparation by the Health Public Welfare Project research “rheumatic autoimmune disease diagnosis and treatment’s key clinical technology promotion and transformation applied research”(here in after referred to as the “project team”),the samples (liquid serum)were given out to the 116 laboratories which were volunteered to participate in antiphospholipid antibodies testing project.Comparison samples include anti-cardiolipin antibodies (ACL), anti-β2-glycoprotein I (β2GPI)antibodies and 1 set of 5 bottles of serum.These samples were sent to each lab by the project team uniformly.The experiment requests each lab to finish testing within the set time,and the results will be uploaded to website.This thesis adopts the Excel to carry on descriptive evaluation and statistical analysis for the test results.Results A total of 116 laboratories took part in the comparative analysis for APLs all over the country.There are each 107 and 63 testing laboratories to participate in the ACL and anti-β2-GPI antibodies.ACL and anti-β2-GPI antibodies in samples of 201,203,and 204 show positive,otherwise the samples of 202 and 205 are double negative.Comparing the testing results of ACL and anti-β2-GPI antibodies,the positive rates were 96.6% and 98.4%,on the contrary,the negative rates was 99.5% and 100%.Enzyme-linked immunosorbent assay (ELISA)is the main method of detection for anti-cardiolipin antibodies and anti-β2-glycoprotein I antibodies,and results among the ELISA kits of different manufacturers showed great volatile (CV 31.0%-90.0%).Conclusion In 2013,the accuracy rates of comparisons of anti-phospholipid antibodies in all labs are higher than 96%.But the standardization and unification of anti-phospholipid antibodies testing results remains to be improved.关键词
抗磷脂综合征/抗心磷脂抗体/抗β2糖蛋白I抗体/比对分析Key words
anti-phospholipid syndrome/anti-cardiolipin antibody/anti-β2-Glycoprotein I antibody/comparison analysis分类
医药卫生引用本文复制引用
宋宁,甘晓丹,史艳萍,李永哲,张奉春,张蜀澜,胡朝军,邓垂文,李萍,白依娜,李丽君,董晓娟,吴子燕..2013年全国116家实验室抗磷脂抗体检测比对分析[J].中华临床免疫和变态反应杂志,2016,10(1):28-32,5.基金项目
卫生公益性行业科研专项“风湿免疫病诊疗关键技术临床推广及转化应用研究”（201202004）； （）
