摘要
目的确认用于转换国际标准的慢性髓性白血病的BCR-ABL（P2lO）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（P21O）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（一）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TRIzol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≤±1．4倍并且95％一致性界限介于士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。
Objective To validate the conversion factor （CF） for the conversion of BCR-ABL （P210） transcript levels to the international 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 l0 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 ≤±1.4 fold and 95% limits of agreement within ±6 fold. Conclusion Validation of CF examined the stability of the detectionof BCR-ABL （P210） transcript levels, which was necessary for the valid conversion of BCR-ABL （P210） transcript levels to the international scale in CML.
出处
《中华血液学杂志》
CAS
CSCD
北大核心
2014年第2期134-137,共4页
Chinese Journal of Hematology
基金
北京市科技计划项目（Z111107067311070）
