2006-2011年中国临床实验室检测自身抗体的室间质量评价

External quality assessment of autoantibodies detection in clinical laboratories during 2006--2011 in China

目的评价我国临床实验室检测自身抗体的能力。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，并回报抗核抗体（ANA）定性结果、核型、滴度、抗可提取核抗原（ENA）抗体和抗dsDNA抗体定性结果，同时计算各项结果的符合率。结果2006—2011年期间采用IIF检测ANA的实验室比例从77．6％（149／192）增长到82．2％（342／416），采用酶联免疫吸附测定法（ELISA）检测ANA的实验室比例在14．5％（53／365）至16．0％（52／326）之间。用IIF法检测ANA阳性符合率在2006--2011年期间均在98％以上，ELISA检On,0的阳性符合率均在90％以上，IIF法每年的阳性符合率均高于ELISA。ANA核型仅为颗粒型的质评样本，除0613和0624号样本外，核型回报结果正确率均〉90％。ANA核型仅为均质型的样本，核型回报结果正确率均t〉95％。ANA核型为着丝点型的样本，2007年核型回报正确率仅为88．5％（161／182）、79．0％（147／186），2010年提高到98．4％（299／304），核型回报正确率呈明显上升趋势。各阳性样本中，报告滴度代码结果为中位数的实验室比例最低的仅为36％（94／261），最高的为85．5％（224／262）。抗ENA抗体总符合率均〉90％，dsDNA抗体总符合率均〉85％。结论IIF法是我国临床实验室进行ANA筛查的主要方法，其次为ELISA，2种方法对ANA定性回报的结果均较为理想。临床实验室对单一着丝点核型的判断有了很大提高，但是对滴度结果的报告尚不理想。ANA检测还有待标准化。（中华捡验医学杂志，2012，35：271-276）

Objective To evaluate the performance of antinuclear antibody （ANA） detection in clinical laboratories. Methods There were 2 external quality assessments （EQA） scheme for nuclear antibody detection. The panel consisting of 5 samples was distributed. Each participant laborotory of the EQA program was required to report the ANA qualitative results, patterns, titers and anti-double strain DNA （dsDNA） antibody, anti-extractable nuclear antigen（ENA） antibody, the percent agreements of which were calculated respectively. Results The number of laboratories performing ANA test with IIF increased from 77. 6% （149/192） in 2006 to 82. 2% （342/416） in 2011, while the number of laboratories performing ANA test with ELISA was in the range of 14.5% （53/365） and 16.0% （52/326）. The positive percent agreements of IIF was over 98%. The positive percent agreement of ELISA were all over 90%. IIF showed more satisfying positive percent agreements than ELISA every year. Over 90% of the laboratories reported correct results for samples with granular ANA pattern except 0613 and 0624. Over 95% of the laboratories reported correct results for samples with homogeneous ANA pattern. Two samples with centromere pattern were correctly detected by 88.5% （ 161/182 ） , 79. 0% （ 147/186 ） of the laboratories in 2007, while the sample with centromere pattern was correctly detected by 98.4% （299/304）, which indicated an improvement in the detection of centromere pattern. In ANA positive results, the lowest percentage of the laboratories reporting the median result was 36% （94/261） , while the highest percentage was only 85.5% （224/262）. The satisfied results of anti-ENA antibody were over 90%. And those of anti-dsDNA antibody was over 85%. Conclusions I1F is the most common method for ANA screening in clinical laboratories. ELISA