中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2012年
3期
271-276
,共6页
张瑞%张括%王露楠%谢洁红%李金明
張瑞%張括%王露楠%謝潔紅%李金明
장서%장괄%왕로남%사길홍%리금명
自身抗体%自身免疫疾病%质量控制%临床实验室技术
自身抗體%自身免疫疾病%質量控製%臨床實驗室技術
자신항체%자신면역질병%질량공제%림상실험실기술
Autoantibodies%Autoimmune diseases%Quality control%Clinical laboratory techniques
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检测的阳性符合率均在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≥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.
目的 評價我國臨床實驗室檢測自身抗體的能力.方法 每年進行2次室間質量評價,每次髮放5支質評樣本；要求各臨床實驗室在規定時間內檢測,併迴報抗覈抗體(ANA)定性結果、覈型、滴度、抗可提取覈抗原(ENA)抗體和抗dsDNA抗體定性結果,同時計算各項結果的符閤率.結果 2006-2011年期間採用IIF檢測ANA的實驗室比例從77.6％ (149/192)增長到82.2％( 342/416),採用酶聯免疫吸附測定法(ELISA)檢測ANA的實驗室比例在14.5％ (53/365)至16.0％( 52/326)之間.用IIF法檢測ANA暘性符閤率在2006-2011年期間均在98％以上,ELISA檢測的暘性符閤率均在90％以上,IIF法每年的暘性符閤率均高于ELISA.ANA覈型僅為顆粒型的質評樣本,除0613和0624號樣本外,覈型迴報結果正確率均＞90％.ANA覈型僅為均質型的樣本,覈型迴報結果正確率均≥95％.ANA覈型為著絲點型的樣本,2007年覈型迴報正確率僅為88.5％( 161/182)、79.0％ (147/186),2010年提高到98.4％ (299/304),覈型迴報正確率呈明顯上升趨勢.各暘性樣本中,報告滴度代碼結果為中位數的實驗室比例最低的僅為36％ (94/261),最高的為85.5％( 224/262).抗ENA抗體總符閤率均＞90％,dsDNA抗體總符閤率均＞85％.結論 IIF法是我國臨床實驗室進行ANA篩查的主要方法,其次為ELISA,2種方法對ANA定性迴報的結果均較為理想.臨床實驗室對單一著絲點覈型的判斷有瞭很大提高,但是對滴度結果的報告尚不理想.ANA檢測還有待標準化.
목적 평개아국림상실험실검측자신항체적능력.방법 매년진행2차실간질량평개,매차발방5지질평양본；요구각림상실험실재규정시간내검측,병회보항핵항체(ANA)정성결과、핵형、적도、항가제취핵항원(ENA)항체화항dsDNA항체정성결과,동시계산각항결과적부합솔.결과 2006-2011년기간채용IIF검측ANA적실험실비례종77.6％ (149/192)증장도82.2％( 342/416),채용매련면역흡부측정법(ELISA)검측ANA적실험실비례재14.5％ (53/365)지16.0％( 52/326)지간.용IIF법검측ANA양성부합솔재2006-2011년기간균재98％이상,ELISA검측적양성부합솔균재90％이상,IIF법매년적양성부합솔균고우ELISA.ANA핵형부위과립형적질평양본,제0613화0624호양본외,핵형회보결과정학솔균＞90％.ANA핵형부위균질형적양본,핵형회보결과정학솔균≥95％.ANA핵형위착사점형적양본,2007년핵형회보정학솔부위88.5％( 161/182)、79.0％ (147/186),2010년제고도98.4％ (299/304),핵형회보정학솔정명현상승추세.각양성양본중,보고적도대마결과위중위수적실험실비례최저적부위36％ (94/261),최고적위85.5％( 224/262).항ENA항체총부합솔균＞90％,dsDNA항체총부합솔균＞85％.결론 IIF법시아국림상실험실진행ANA사사적주요방법,기차위ELISA,2충방법대ANA정성회보적결과균교위이상.림상실험실대단일착사점핵형적판단유료흔대제고,단시대적도결과적보고상불이상.ANA검측환유대표준화.
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 IIF is the most common method for ANA screening in clinical laboratories.ELISA is also used in some laboratories.The two methods reported satisfying results in ANA test.The detection of anticentromere antibodies is improved.But the results of ANA titer reported are unsatisfactory. ANA detection in routine practice needs to be improved by standardization.
