中文摘要：

目的调查全国抗核抗体谱（ANAs）的检测现状,以改进和提高其检测水平与质量。方法由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＂项目组向全国229家自愿报名参加ANAs检测的实验室发放比对品。比对品可检测抗核抗体（ANA）、抗双链DNA（ds DNA）抗体、抗可提取性核抗原（ENA）抗体,共计一组5支血清。由项目组统一寄送至各实验室。各实验室在规定日期内使用常规方法检测,并将结果上传至项目组比对网站。采用Excel软件对检测结果进行统计及描述性评价。结果参加ANA、抗ds DNA抗体及抗ENA抗体检测的实验室数目分别为217家、219家和223家。ANA、抗ds DNA抗体检测定性结果阳性符合率分别为98.9%和89.5%,阴性符合率分别为97.2%和98.8%。间接免疫荧光法（IIF）是检测ANA的主要方法,核型回报正确率高于89.5%,滴度回报结果在可接收范围内的正确率高于81.8%。抗ds DNA抗体应用免疫印迹法检测结果阴性符合率高于96%,但阳性符合率仅为76%,明显低于IIF法95.4%及ELISA法97.9%。抗ENA抗体检测结果阳性符合率高于94%。结论 2013年全国参与ANAs质评实验室的数量较以往明显增加。比对品的定性结果符合率理想,核型符合率较为理想,滴度和定量结果符合率有待提高。

英文摘要：

Objective To investigate the current situation of antinuclear antibody （ANA） spectrum detection in China so as to improve and enhance its detection quality. Methods Five serum samples for the detection of ANA, anti-dsDNA antibody, and anti-ENA anti- bodies were distributed to 229 laboratories which volunteered to participate in the ANA-testing project - Applied Research of Key Clini- cal Technology Promotion and Transformation for the Diagnosis and Treatment of Rheumatic Autoimmune Diseases launched by the Health Public Welfare Project. Then, the titers of ANA, anti-dsDNA antibody, and anti-ENA antibodies in these samples were detec- ted by routine methods, and the results were uploaded to the website of the project within the set time. All the results were written into the Excel and performed statistical analysis and descriptive evaluation. Results There were 217, 219 and 223 laboratories which de- tected the ANA, anti-dsDNA antibody and anti-ENA antibodies, respectively. The positive coincidence rates for ANA and anti-dsDNA antibody were 98.9% and 89.5% , respectively, while the negative coincidence rates were 97.2% and 98.8% , respectively. The main method detected ANA was indirect immunofluorescence （ IIF）, and the accuracy rates were above 89.5% and 81.8% for the dis- tribution of nuclear fluorescence and the titers, respectively. The negative coincidence rate of anti-dsDNA antibody detected by immu- noblotting was above 96%, but the positive coincidence rate was only 76%, which was significantly lower than those from IIF （95.4%） and ELISA （97.9%）. The positive coincidence rate of anti-ENA antibody was above 94%. Conclusion In 2013, the number of laboratories participated in the ANA-testing project increased obviously. The coincidence rates of qualitative results and the nuclear fluorescence distribution results are high, while those of quantitative results need to be improved.