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
265-270
,共6页
李丽君%张蜀澜%李永哲%张奉春
李麗君%張蜀瀾%李永哲%張奉春
리려군%장촉란%리영철%장봉춘
自身抗体%质量控制%实验室,医院
自身抗體%質量控製%實驗室,醫院
자신항체%질량공제%실험실,의원
Autoantibodies%Quality control%Laboratories,hospital
目的 了解我国自身抗体检测现状,以改进和提高自身抗体检测质量.方法 对2009年自愿报名参加白身抗体检测质量评价的102家实验室,于2009年10月发放日本MBL公司提供的抗核抗体( ANA)、抗双链DNA(dsDNA)抗体、抗可提取核抗原(ENA)抗体、抗线粒体抗体(AMA)/抗平滑肌抗体(ASMA)和抗环瓜氨酸肽(CCP)抗体各3份质控品,共15份质控样本.各单位按各自的常规方法检测,并将检测项目的定性结果(ANA、抗dsDNA抗体、抗ENA抗体、AMA/ASMA、抗CCP抗体)、核型(ANA)、滴度(ANA、抗dsDNA抗体、AMA/ASMA)以及检测所用方法等结果填入统一表格寄回.该15份质控标本也同时向希腊、意大利、日本、韩国、葡萄牙及中国台湾等其他地区的实验室发放,回报结果由日本MBL公司进行统计分析,中国实验室回报结果的统计分析由本实验室完成.质控样本发放和结果分析均采用双盲操作,采用Excel软件对回报结果进行统计及描述性评价.因自身抗体检测的特殊性,仅对定性结果采用正确率(3份样本检测结果均正确回报的实验室数/参加该项目检测实验室总数)进行描述性评价,定量结果仅供参考.结果 以日本MBL公司2009年在各国家及地区自身抗体检测评价的揭盲结果为评判依据,ANA、抗dsDNA抗体、AMA、ASMA、抗ENA抗体和抗CCP抗体质控样品的正确率分别为80.8％ (80/99)、81.2％ (78/96)、86.3％(44/51)、76.3％ (29/38)、95.9％ (93/97)和93.1％ (67/72).间接免疫荧光法检测ANA滴度的正确率较低,901号样本为12.7％ (11/79),902号样本为7.6％ (6/79).抗CCP抗体不同厂家试剂盒检测结果波动较大,921号和923号样本检测值的波动范围分别为10.0 ～419.0、15.3～418.5 U/ml.结论 2009年我国ANA、抗dsDNA抗体、AMA和ASMA检测的正确率均低于90％,而抗ENA抗体和抗CCP抗体检测的正确率令人满意(均＞90％).ANA的核型与滴度、AMA和ASMA检测的室内质控以及抗CCP抗体检测的室间质控仍有待提高.
目的 瞭解我國自身抗體檢測現狀,以改進和提高自身抗體檢測質量.方法 對2009年自願報名參加白身抗體檢測質量評價的102傢實驗室,于2009年10月髮放日本MBL公司提供的抗覈抗體( ANA)、抗雙鏈DNA(dsDNA)抗體、抗可提取覈抗原(ENA)抗體、抗線粒體抗體(AMA)/抗平滑肌抗體(ASMA)和抗環瓜氨痠肽(CCP)抗體各3份質控品,共15份質控樣本.各單位按各自的常規方法檢測,併將檢測項目的定性結果(ANA、抗dsDNA抗體、抗ENA抗體、AMA/ASMA、抗CCP抗體)、覈型(ANA)、滴度(ANA、抗dsDNA抗體、AMA/ASMA)以及檢測所用方法等結果填入統一錶格寄迴.該15份質控標本也同時嚮希臘、意大利、日本、韓國、葡萄牙及中國檯灣等其他地區的實驗室髮放,迴報結果由日本MBL公司進行統計分析,中國實驗室迴報結果的統計分析由本實驗室完成.質控樣本髮放和結果分析均採用雙盲操作,採用Excel軟件對迴報結果進行統計及描述性評價.因自身抗體檢測的特殊性,僅對定性結果採用正確率(3份樣本檢測結果均正確迴報的實驗室數/參加該項目檢測實驗室總數)進行描述性評價,定量結果僅供參攷.結果 以日本MBL公司2009年在各國傢及地區自身抗體檢測評價的揭盲結果為評判依據,ANA、抗dsDNA抗體、AMA、ASMA、抗ENA抗體和抗CCP抗體質控樣品的正確率分彆為80.8％ (80/99)、81.2％ (78/96)、86.3％(44/51)、76.3％ (29/38)、95.9％ (93/97)和93.1％ (67/72).間接免疫熒光法檢測ANA滴度的正確率較低,901號樣本為12.7％ (11/79),902號樣本為7.6％ (6/79).抗CCP抗體不同廠傢試劑盒檢測結果波動較大,921號和923號樣本檢測值的波動範圍分彆為10.0 ～419.0、15.3～418.5 U/ml.結論 2009年我國ANA、抗dsDNA抗體、AMA和ASMA檢測的正確率均低于90％,而抗ENA抗體和抗CCP抗體檢測的正確率令人滿意(均＞90％).ANA的覈型與滴度、AMA和ASMA檢測的室內質控以及抗CCP抗體檢測的室間質控仍有待提高.
목적 료해아국자신항체검측현상,이개진화제고자신항체검측질량.방법 대2009년자원보명삼가백신항체검측질량평개적102가실험실,우2009년10월발방일본MBL공사제공적항핵항체( ANA)、항쌍련DNA(dsDNA)항체、항가제취핵항원(ENA)항체、항선립체항체(AMA)/항평활기항체(ASMA)화항배과안산태(CCP)항체각3빈질공품,공15빈질공양본.각단위안각자적상규방법검측,병장검측항목적정성결과(ANA、항dsDNA항체、항ENA항체、AMA/ASMA、항CCP항체)、핵형(ANA)、적도(ANA、항dsDNA항체、AMA/ASMA)이급검측소용방법등결과전입통일표격기회.해15빈질공표본야동시향희석、의대리、일본、한국、포도아급중국태만등기타지구적실험실발방,회보결과유일본MBL공사진행통계분석,중국실험실회보결과적통계분석유본실험실완성.질공양본발방화결과분석균채용쌍맹조작,채용Excel연건대회보결과진행통계급묘술성평개.인자신항체검측적특수성,부대정성결과채용정학솔(3빈양본검측결과균정학회보적실험실수/삼가해항목검측실험실총수)진행묘술성평개,정량결과부공삼고.결과 이일본MBL공사2009년재각국가급지구자신항체검측평개적게맹결과위평판의거,ANA、항dsDNA항체、AMA、ASMA、항ENA항체화항CCP항체질공양품적정학솔분별위80.8％ (80/99)、81.2％ (78/96)、86.3％(44/51)、76.3％ (29/38)、95.9％ (93/97)화93.1％ (67/72).간접면역형광법검측ANA적도적정학솔교저,901호양본위12.7％ (11/79),902호양본위7.6％ (6/79).항CCP항체불동엄가시제합검측결과파동교대,921호화923호양본검측치적파동범위분별위10.0 ～419.0、15.3～418.5 U/ml.결론 2009년아국ANA、항dsDNA항체、AMA화ASMA검측적정학솔균저우90％,이항ENA항체화항CCP항체검측적정학솔령인만의(균＞90％).ANA적핵형여적도、AMA화ASMA검측적실내질공이급항CCP항체검측적실간질공잉유대제고.
Objective To evaluate and improve the quality of autoantibodies testing in China.Methods 102 laboratories participated voluntarily in the survey of the quality of autoantibodies testing in October 2009 and received a total of 15 samples from Japan MBL company including 5 different assays:antinuclear antibody ( ANA),anti-double strain DNA (dsDNA) antibody,anti-extractable nuclear antigen (ENA) antibody,anti-mitochondrial antibody ( AMA),anti-smooth muscle antibody ( ASMA ) and anti-cyclic citrollinated peptide (CCP) antibodies.There were 3 samples for each assay.The samples were detected by routine methods.The results were reported with qualitive results (for all),titer (for ANA,antidsDNA antibody and AMA/ASMA),patterns (for ANA) and methods.At the same time,MBL company also distributed the samples to the laborotories in the other areas,Greece,Italy,Japan,Korea,Portugue and China Taiwan,respectively.The results from the other areas were analyzed by MBL company.The results from China were analyzed in our laborotories.The distribution of samples and analysis of testing results was double-blinded.Descriptive analysis were performed with Excel.Only descriptive analysis of the qualitiveresult,positive rate (laboratories that all three results were right/laboratories that took part in the relevant autoantibody detection) were done,and quantity results were set as reference.Results According to the standard results from the analysis of MBL company the rate of satisfied results of ANA,anti-dsDNA antibody,AMA,ASMA,anti-ENA antibody and anti-CCP were 80.8％ ( 80/99 ),81.2％ ( 78/96 ),86.3％ (44/51),76.3％ (29/38),95.9％ (93/97) and 93.1％ (67/72),respectively.The accuracy rate of the titer for ANA was low and related results of sample 901 and 902 were 12.7％ (11/79) and 7.6％ (6/79),respectively.Also a considerable discrepancy was found in the results of anti-CCP among different laboratories using different commercial kits.The ranges of sample 921 and 923 were 10.0-419.0 U/ml and 15.3-418.5 U/ml,respectively.Conclusions The accuracy rates of the rate of satisfied results among ANA,anti-dsDNA antibody,AMA,and ASMA were lower than 90％,however,it's satisfed that the rate is higher than 90％ in anti-ENA antibody and anti-CCP.Internal quality control of ANA titer,AMA and ASMA,and external quality assurance of anti-CCP should be improved.
