CAJ | 학술논문

目的确认用于转换国际标准的慢性髓性白血病的BCR-ABL (P210)转录本水平的转换系数(CF)的有效性.方法 2012年澳大利亚医学与兽医科学研究所(IMVS)国际参比实验室寄送2批各30份RNA样本至北京大学人民医院(简称人民医院),通过双方BCR-ABL(P210)转录本水平检测值的比较,人民医院计算并确认用于转换国际标准的BCR-ABL(P210)转录本水平的CF.2013年人民医院统一制备用于确认9家医院之前已计算出的CF的比对样品,即用新鲜的BCR-ABL(-)患者骨髓有核细胞稀释BCR-ABL(P210)(+)细胞制备出 22种不同BCR-ABL水平的样本,每种样本各制备10份平行样本,加入TRhol中.每家医院各检测1套样品.各医院的检测值分别与人民医院的检测值比较,进行Bland-Altman一致性分析.结果通过IMVS的确认,人民医院成功获得有效的CF,偏倚为1.1倍,95％一致性界限为-4.7～ 4.9倍.9家医院中,6家医院达到偏倚≤±l.4倍并且95％一致性界限介于±6.0倍之间的标准,说明已计算出的CF有效.结论 CF的确认检验了BCR-ABL(P210)转录本水平检测的稳定性,对获得有效的转换国际标准的CF是必要的.
목적 학인용우전환국제표준적만성수성백혈병적BCR-ABL (P210)전록본수평적전환계수(CF)적유효성.방법 2012년오대리아의학여수의과학연구소(IMVS)국제삼비실험실기송2비각30빈RNA양본지북경대학인민의원(간칭인민의원),통과쌍방BCR-ABL(P210)전록본수평검측치적비교,인민의원계산병학인용우전환국제표준적BCR-ABL(P210)전록본수평적CF.2013년인민의원통일제비용우학인9가의원지전이계산출적CF적비대양품,즉용신선적BCR-ABL(-)환자골수유핵세포희석BCR-ABL(P210)(+)세포제비출 22충불동BCR-ABL수평적양본,매충양본각제비10빈평행양본,가입TRhol중.매가의원각검측1투양품.각의원적검측치분별여인민의원적검측치비교,진행Bland-Altman일치성분석.결과 통과IMVS적학인,인민의원성공획득유효적CF,편의위1.1배,95％일치성계한위-4.7～ 4.9배.9가의원중,6가의원체도편의≤±l.4배병차95％일치성계한개우±6.0배지간적표준,설명이계산출적CF유효.결론 CF적학인검험료BCR-ABL(P210)전록본수평검측적은정성,대획득유효적전환국제표준적CF시필요적.
Objective To validate the conversion factor (CF) for the conversion of BCR-ABL (P210) transcript levels to the intemational scale in chronic myeloid leukemia (CML).Methods In 2012,the international reference laboratory in Adelaide,Australia (IMVS) sent two batches of RNA samples,30 samples per batch,to Peking University People' s Hospital (PKUPH).By comparing BCR-ABL (P210) transcript levels reported by the two laboratories,CF of PKUPH was calculated and validated by IMVS.In 2013,PKUPH prepared the exchange samples for validation of CF of 9 hospitals who have calculated CFs before.The fresh BCR-ABL (P210) (+) cells were serially diluted by BCR-ABL (P210) (-) cells to prepare 22 kinds of samples with different BCR-ABL transcript levels,each kind had 10 parallel samples.Trizol reagent was added in each tube.Ten hospitals tested BCR-ABL transcript levels of one set of 22 samples.Agreement between BCR-ABL transcript levels of each laboratory and PKUPH was assessed by the Bland-Altman method.Results PKUPH successfully validated its CF with bias 1.1 fold and 95％ limits of agreement between-4.7 and 4.9 fold.Of 9 hospitals whose validation performed by sample exchanges with PKUPH,6 hospitals successfully validated their CF with bias ≤ 4±1.4 fold and 95％ limits of agreement within ±6 fold.Conclusion Validation of CF examined the stability of the detection of BCR-ABL (P210) transcript levels,which was necessary for the valid conversion of BCR-ABL (P210) transcript levels to the international scale in CML.