CAJ | 학술논문

目的：再确认已获得的用于转换慢性髓性白血病国际标准化的BCR-ABL（P210）转录本水平（BCR-ABLIS）的转换系数（CF）的有效性。方法北京大学人民医院（简称PKUPH）统一制备用于再确认15家单位9或18个月之前已获得的CF的比对样品，即用BCR-ABL阴性患者骨髓或外周血有核细胞稀释BCR-ABL（P210）阳性细胞制备出相同16套、每套24种不同BCR-ABL水平的样本，加入TRIzol中。15家单位分别检测1套，采用GraphPad Prism 5.0软件对其与PKUPH的BCR-ABLIS检测值分别进行Bland-Altman一致性分析。对于未达到再确认标准的单位，去除结果明显偏离的样本直至其检测值与PKUPH的BCR-ABLIS之间的回归方程相关系数>0.98，来计算新的CF。结果10家单位达到标准（偏倚介于±1.4倍，且95%可信区间介于±6.0倍），说明原有的CF依然准确，可以继续有效转换BCR-ABLIS。5家未达到标准的单位通过重新计算得出新的CF，分别是原有CF的1.8～6.3倍。结论通过室间样本比对的CF再确认过程既检验了原有CF是否依然有效，又使CF不再有效的单位获得新的适用于当前的CF，保持了BCR-ABLIS应用的准确性和连续性。
목적：재학인이획득적용우전환만성수성백혈병국제표준화적BCR-ABL（P210）전록본수평（BCR-ABLIS）적전환계수（CF）적유효성。방법북경대학인민의원（간칭PKUPH）통일제비용우재학인15가단위9혹18개월지전이획득적CF적비대양품，즉용BCR-ABL음성환자골수혹외주혈유핵세포희석BCR-ABL（P210）양성세포제비출상동16투、매투24충불동BCR-ABL수평적양본，가입TRIzol중。15가단위분별검측1투，채용GraphPad Prism 5.0연건대기여PKUPH적BCR-ABLIS검측치분별진행Bland-Altman일치성분석。대우미체도재학인표준적단위，거제결과명현편리적양본직지기검측치여PKUPH적BCR-ABLIS지간적회귀방정상관계수>0.98，래계산신적CF。결과10가단위체도표준（편의개우±1.4배，차95%가신구간개우±6.0배），설명원유적CF의연준학，가이계속유효전환BCR-ABLIS。5가미체도표준적단위통과중신계산득출신적CF，분별시원유CF적1.8～6.3배。결론통과실간양본비대적CF재학인과정기검험료원유CF시부의연유효，우사CF불재유효적단위획득신적괄용우당전적CF，보지료BCR-ABLIS응용적준학성화련속성。
Objective To revalidate the conversion factor(CF)for the conversion of BCR-ABL (P210) transcript levels to the international scale (BCR-ABLIS)in chronic myeloid leukemia (CML) which validated before. Methods Peking University People’s Hospital(PKUPH)prepared the exchange samples for revalidation of CFs of 15 laboratories which validated nine or eighteen months ago. The fresh BCR-ABL(P210)(+)bone morrow or peripheral blood nucleated cells were diluted with BCR-ABL (P210)(-) cells to achieve different BCR-ABL levels, totally 16 sets and 24 samples per set were prepared. TRIzol reagent was added in each tube. Each laboratory tested BCR-ABL transcript levels of one set of samples. Agreement between BCR-ABLIS of each laboratory and PKUPH was assessed by the Bland-Altman method. For laboratories which did not meet the criteria of revalidation, linear regression equation was derived after the samples with maximum BCR-ABL deviation were removed until R2>0.98, then new CF was calculated. Results 10 laboratories met the revalidation criteria with both bias within ± 1.4 fold and 95%limits of agreement within ±6 folds, and their CFs still could be used for accurately conversion of BCR-ABLIS. New CFs were recalculated as of 1.8-6.3 folds of their previous CFs in 5 laboratories not met the criteria. Conclusion Revalidation of CF by sample exchange among laboratories was necessary for accurate and continuous application of BCR-ABLIS, which not only tested the validity of CF acquired before but also calculated new available CFs for those with invalid CFs.