2013年全国175家临床实验室检测抗中性粒细胞胞浆抗体的比对分析

Analyses of the Multi-center Comparison of Anti-neutrophil Cytoplasmic Antibodies Testing from 175 Laboratories in 2013 in China

目的 通过全国多中心实验室自身抗体检测比对活动,了解国内抗中性粒细胞胞浆抗体的检测水平现状,以提高检测质量.方法 由卫生公益性行业科研专项＆quot;风湿免疫病诊疗关键技术临床推广及转化应用研究＆quot;项目组（以下称＆quot;项目组＆quot;）制备自身抗体比对样品（液体血清）,向全国175家自愿报名参加抗中性粒细胞胞浆抗体检测的实验室发放比对品.比对品包含抗中性粒细胞胞浆抗体（ANCA）阳性或阴性、抗髓过氧化物酶（MPO）抗体阳性或抗蛋白酶3（PR3）抗体阳性,共计1组5支血清.由项目组统一寄送至各实验室.要求各实验室在规定时间内完成检测,并将结果上传至项目组.采用Excel软件对检测结果进行统计分析.结果 参加ANCA,抗MPO抗体及抗PR3抗体检测比对工作的实验室数目分别为134家,148家和148家.ANCA,抗MPO抗体及抗PR3抗体比对品检测结果阳性符合率分别为90.8％,98.0％和98.0％,阴性符合率分别为94.4％,96.1％和98.8％.间接免疫荧光法为国内实验室检测ANCA的主要方法,但回报的结果符合率参差不齐,荧光模型回报率尚不理想,仅为77.9％.结论 2013年全国实验室检测ANCA比对品的阳性符合率尚不理想,且应用ⅡF法检测ANCA时荧光模型回报率不高.抗MPO抗体及抗PR3抗体比对结果较为满意.ANCA检测质量仍有待提高.

Objective To survey and analyses the current situation of autoantibodies testing of anti-neutrophil cytoplasmic an- tibodies（ANCA） in China for evidence of further improvement of detecting quality. Methods 175 laboratories participated voluntarily in the study of multi-center comparison of ANCA testing. The samples（serum liquid） were prepared by the group of clinical promotion and translation application research of key technology of diagnosis and treatment of autoimmune disea- ses of the Research Special Fund for Public Welfare Industry of Health （＂the group＂ for short） ,including 5 ANCA samples, 5 anti-myeloperoxidase （MPO） antibodies samples and 5 anti-proteinase 3 （PR3） antibodies samples,which were mailed to laboratories. The group preformed analysis of the results by Excel,including coincidence rate and titer report rate. Results The laboratories that eventually participated in ANCA, anti-MPO and anti-PR3 were 134,148 and 148, respectively,and the positive coincidence rate were 90.8%, 98.0%and 98.0%, respectively, meanwhile the negative coincidence rate were 94.4 %, 96.1% and 98.8%,respectively. Indirect immunofluorescence（IIF） was the most common method for detection of ANCA. ANCA about the fluoresence pattern were also not ideal and the concordance rate only was 77.9%. Conclusion In 2013, the positive coincidence rate of ANCA is not ＇satisfying in clinical labs of China,while the negative coincidence rate was good. IIF method used for idetifying the ANCA fluorescence pattern only got relative low rate of reported results. The coin cidence rate of anti-MPO and anti-PR3 were satisfying in clinical labs of China. In conclusion, detecting quality of ANCA re- mains to be improved.