Mauté Carole, Nibourel Olivier, Réa Delphine, Coiteux Valérie, Grardel Nathalie, Preudhomme Claude, Cayuela Jean-Michel
Laboratory of Hematology, University Hospital Saint-Louis, AP-HP, Paris, France.
Laboratory of Hematology, CHRU, Lille, France.
Clin Biochem. 2014 Sep;47(13-14):1333-6. doi: 10.1016/j.clinbiochem.2014.05.067. Epub 2014 Jun 8.
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.
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).
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.
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.
直到最近，想要进行国际规模报告的诊断实验室选择有限：它们必须通过与参考实验室进行样本交换来调整其BCR-ABL1定量方法，以得出转换因子。然而，现在有基于世界卫生组织基因参考面板校准的商业方法。我们报告了一项旨在评估两种校准策略可比性的研究结果。
纳入了60例慢性髓性白血病患者的随访样本。将两种基于基因参考面板校准的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比较。结果与一致性标准进行匹配（即分别在2倍、3倍和5倍范围内获得患者样本的以下三个界标中的至少两个：50%、75%和90%）。
在60个样本中，有超过32个可用于比较。与转换因子方法相比，在圣路易分析的样本中，两种商业方法分别在2倍、3倍和5倍范围内的样本比例为53%和59%、89%和88%、100%和97%。在里尔，结果分别为45%和85%、76%和97%、100%和100%。在进行的四项比较中均观察到方法之间的一致性。
我们的数据表明，所选的两种商业方法与转换因子方法一致。这项研究提供了原理证明，即使用基因参考面板在国际规模上进行校准与患者样本交换程序兼容。我们认为这些结果对于希望采用商业方法的诊断实验室尤为重要。
