Scott Stuart, Travis Debbie, Whitby Liam, Bainbridge John, Cross Nicholas C P, Barnett David
UKNEQAS for Leucocyte Immunophenotyping, Sheffield Teaching Hospitals, Sheffield, UK.
Biostatistics Center, Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Br J Haematol. 2017 May;177(3):414-422. doi: 10.1111/bjh.14557. Epub 2017 Mar 14.
Sequential measurement of BCR-ABL1 mRNA levels by reverse transcription quantitative polymerase chain reaction (RT-qPCR) is embedded in the management of patients with chronic myeloid leukaemia (CML), and has played an important role in the remarkable improvement in patient outcomes seen in this disease. As a provider of external quality assessment (EQA) in this area, UK NEQAS for Leucocyte Immunophenotyping (UKNEQAS LI) has a unique perspective on the changing face of BCR-ABL1 testing in CML. To assess the impact of technical standardisation and the development of the International Scale (IS) upon the accuracy of BCR-ABL1 testing, we reviewed EQA trial data from 2007 to 2015. Comparison of participant results identified considerable variability at both high and low levels of disease, including therapeutically important decision points; however, results converted to the IS showed less variability compared to unconverted data sets. We also found that different methods of converting to the IS produce consistently different median results within UKNEQAS LI IS data sets. This data suggests that whilst the development of the IS has improved the comparability of results between centres, there is still the need for further improvement in the processes of converting raw results to the IS in order to fully realise the benefits of molecular monitoring of CML.
通过逆转录定量聚合酶链反应（RT-qPCR）对BCR-ABL1 mRNA水平进行连续测量已融入慢性粒细胞白血病（CML）患者的管理中，并在该疾病患者预后的显著改善中发挥了重要作用。作为该领域外部质量评估（EQA）的提供者，英国白细胞免疫表型分析外部质量评估计划（UKNEQAS LI）对CML中BCR-ABL1检测不断变化的情况有着独特的见解。为了评估技术标准化和国际量表（IS）的发展对BCR-ABL1检测准确性的影响，我们回顾了2007年至2015年的EQA试验数据。对参与者结果的比较发现，在疾病的高、低水平，包括具有治疗重要性的决策点，都存在相当大的变异性；然而，与未转换的数据集相比，转换为IS的结果显示出较小的变异性。我们还发现，在UKNEQAS LI IS数据集中，不同的转换为IS的方法会产生始终不同的中位数结果。这些数据表明，虽然IS的发展提高了各中心之间结果的可比性，但仍需要进一步改进将原始结果转换为IS的过程，以便充分实现CML分子监测的益处。
