抗核抗体谱检测的室间质量评价

目的 评价全国临床实验室检测抗核抗体谱的能力。方法 每年进行2次室间质量评价，每次发放5支质评样本；要求各临床实验室在规定时间内检测，并回报检测结果、所用检测方法、仪器和试剂资料；卫生部临床检验中心对各实验室的结果进行统计分析，最后将结果反馈给各实验室。结果70％以上的实验室采用间接免疫荧光法测定抗核抗体谱，2003-2005年的阳性符合率分别为94．1％、93．0％和98．6％。对单一核型，包括均质型、颗粒型等检测结果符合率明显高于混合核型的检测。阳性样本，各实验室回报的滴度存在很大差异。可提取性核抗原抗体谱的检测方法主要有酶联免疫吸附法、间接免疫荧光法和免疫印迹法，采用免疫印迹法的实验室占90％以上，检测结果符合率存在明显差异。抗双链DNA（抗dsDNA）抗体检测整体成绩均接近或超过90％。结论 抗核抗体的检测还有待于标准化。通过抗核抗体谱临床检验实验室间质量评价，可及时发现参评实验室检测中存在的问题，促进实验室不断提高检测质量。

External quality assessment on antinuclear antibody detection

Objective To evaluate the performance of antinuclear antibody (ANA) detection in clinical laboratories. Methods There were 2 external quality assessments ( EQA) for nuclear antibody detection. The panel consisting of 5 liquid serum samples was distributed. Each participants of the EQA program should include in their report the results, the methodological procedure and the kits used . All data were analyzed then distributed to all laboratories in our EQA program. Results During 2003 to 2005, more than 70% laboratories detected antinuclear antibody by using indirect immunofluorescence(IIF) method and the rate of acceptable response list were 94. 1% , 93. 0% and 98. 6% , respectively. We have got better result from signals fluorescence pattern such as homogeneous and speckled than multiplicity samples. A wide dispersion of ANA titers was obtained every year. We neceived different rate from different methods of anti-ENA detection and 90% laboratories used immunoblot method. For anti-dsDNA most participants gave us acceptable performance. Conclusions ANA detection in routine practice is far from being standardized. However, EQA can have an impact on ANA detection performance if it provides advice for participating laboratories to limited laboratory variations related to method, procedure and kits.