Maes B, Bakkus M, Boeckx N, Boone E, Cauwelier B, Denys B, De Schouwer P, Devos T, El Housni H, Hillen F, Jacobs K, Lambert F, Louagie H, Maes M-B, Meeus P, Moreau E, Nollet F, Peeters K, Saussoy P, Van Lint P, Vaerman J-L, Vaeyens F, Vandepoele K, Vannuffel P, Ver Elst K, Vermeulen K, Bruyndonckx R
Laboratory for Molecular Diagnostics, Jessa Hospital, Hasselt, Belgium.
Laboratory of Haematology, University Hospital Brussels, Brussels, Belgium.
Int J Lab Hematol. 2016 Dec;38(6):674-684. doi: 10.1111/ijlh.12556. Epub 2016 Jul 27.
Standardization of BCR-ABL1 messenger RNA quantification by real-time PCR on the International Scale (IS) is critical for monitoring therapy response in chronic myelogenous leukaemia. Since 2006, BCR-ABL1 IS standardization is propagated along reference laboratories by calculating a laboratory-specific conversion factor (CF), co-ordinated in Europe through the European Treatment and Outcome Study project. Although this process has proven successful to some extent, it has not been achievable for all laboratories due to the complexity of the process and the stringent requirements in terms of numbers of samples to be exchanged. In addition, several BCR-ABL1 IS quantification methods and secondary reference materials became commercially available. However, it was observed that different IS methods generate consistently different results.
To overcome these difficulties, we have developed an alternative and simple approach of CF calculation, based on the retrospective analysis of existing external quality assessment (EQA) data. Our approach does not depend on the exchange of samples and is solely based on the mathematical CF calculation using EQA results.
We have demonstrated by thorough statistical validation that this approach performs well in converting BCR-ABL1 measurements to improve IS estimation. In expectation of a true golden standard method for BCR-ABL1 IS quantification, the proposed method is a valuable alternative.
通过国际标准（IS）实时定量聚合酶链反应对BCR-ABL1信使核糖核酸进行标准化，对于监测慢性粒细胞白血病的治疗反应至关重要。自2006年以来，通过计算特定实验室的转换因子（CF），在参考实验室中推广BCR-ABL1国际标准，该转换因子在欧洲通过欧洲治疗与结果研究项目进行协调。尽管这一过程在一定程度上已被证明是成功的，但由于过程的复杂性以及样本交换数量方面的严格要求，并非所有实验室都能实现。此外，几种BCR-ABL1国际标准定量方法和二级参考材料已商业化。然而，人们观察到不同的国际标准方法产生的结果始终存在差异。
为克服这些困难，我们基于对现有外部质量评估（EQA）数据的回顾性分析，开发了一种替代的、简单的转换因子计算方法。我们的方法不依赖于样本交换，仅基于使用EQA结果进行的数学转换因子计算。
我们通过全面的统计验证表明，这种方法在转换BCR-ABL1测量值以改进国际标准估计方面表现良好。在期待一种真正的BCR-ABL1国际标准定量金标准方法的情况下，所提出的方法是一种有价值的替代方法。
