Calibration of BCR-ABL1 mRNA quantification methods using genetic reference materials is a valid strategy to report results on the international scale
Calibration of BCR-ABL1 mRNA quantification methods using genetic reference materials is a valid strategy to report results on the international scale
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DOI：
10.1016/j.clinbiochem.2014.05.067
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发表时间：
2014-09-01
影响因子：
2.8
通讯作者：
Cayuela, Jean-Michel
中科院分区：
文献类型：
--
作者：
Maute, Carole;Nibourel, Olivier;Cayuela, Jean-Michel
目的：直到最近，想要在国际范围内报告的诊断实验室的选择有限：他们必须通过与参考实验室的样品交换来调整他们的BCR-ABL1定量方法，以得出转换因子。但是，现在可以使用根据世界卫生组织遗传参考小组校准的商业方法。我们报告了一项研究的结果，该研究旨在评估两种对齐策略的可比性。设计与方法：随访60例慢性髓性白血病患者。在遗传参考面板上校准的两种商业方法与巴黎圣路易医院和里尔大学医院常规使用的两种转换因子方法进行了比较。结果与一致性标准相匹配（即获得以下三个里程碑中的至少两个：分别在2倍，3倍和5倍范围内的患者样本的50%，75%和90%）。结果：60份样本中有32份以上可供比较。与转换因子法相比，两种商业方法对Saint-Louis分析的样品的回收率分别为53%和59%、89%和88%、100%和97%，分别在2倍、3倍和5倍范围内。在里尔，结果分别为45和85%，76和97%，100和100%。在进行的四种比较中观察到方法之间的一致性。结论：我们的数据表明，所选择的两种商业方法与转换因子法是一致的。这项研究证明了在国际范围内使用遗传参考小组进行比对与患者样本交换程序是兼容的。我们认为，这些结果对希望采用商业方法的诊断实验室尤其重要。(C) 2014加拿大临床化学学会。Elsevier Inc.出版。版权所有。
Objectives: Until recently, diagnostic laboratories that wanted to report on the international scale had limited options: they had to align their BCR-ABL1 quantification methods through a sample exchange with a reference laboratory to derive a conversion factor. However, commercial methods calibrated on the World Health Organization genetic reference panel are now available. We report results from a study designed to assess the comparability of the two alignment strategies.Design and methods: Sixty follow-up samples from chronic myeloid leukemia patients were included. Two commercial methods calibrated on the genetic reference panel were compared to two conversion factor methods routinely used at Saint-Louis Hospital, Paris, and at Lille University Hospital. Results were matched against concordance criteria (i.e., obtaining at least two of the three following landmarks: 50, 75 and 90% of the patient samples within a 2-fold, 3-fold and 5-fold range, respectively).Results: Out of the 60 samples, more than 32 were available for comparison. Compared to the conversion factor method, the two commercial methods were within a 2-fold, 3-fold and 5-fold range for 53 and 59%, 89 and 88%, 100 and 97%, respectively of the samples analyzed at Saint-Louis. At Lille, results were 45 and 85%, 76 and 97%, 100 and 100%, respectively. Agreements between methods were observed in the four comparisons performed.Conclusion: Our data show that the two commercial methods selected are concordant with the conversion factor methods. This study brings the proof of principle that alignment on the international scale using the genetic reference panel is compatible with the patient sample exchange procedure. We believe that these results are particularly important for diagnostic laboratories wishing to adopt commercial methods. (C) 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.