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首页> 美国卫生研究院文献>Blood Cancer Journal >Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR–ABL1 on the international reporting scale
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Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR–ABL1 on the international reporting scale

机译：建立具有国际报告规模上定量测量BCR–ABL1所需的分析性能的标准化多元测定法

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Accurate and standardized methods for the quantitative measurement of BCR–ABL1 are a prerequisite for monitoring of treatment response in t(9;22)-positive leukemia. Here, we describe a novel multiplex assay system based on the proven TaqMan and Armored RNA technologies and optimized for sensitive detection of three BCR–ABL1 fusion transcripts and ABL1 in a single reaction. Analytical experiments confirmed the absence of significant competition between the simultaneous amplification reactions and established the sensitivity, linearity and precision of the assay. Comparative studies with 115 clinical specimens resulted in high qualitative and quantitative agreement with independent singleplex laboratory-developed tests routinely used in clinical testing. Direct comparison with a reference laboratory calibrated to the international scale (IS) demonstrated minimal analytical bias between methods and an overall accuracy and precision within the performance range required for quantitative measurement of BCR–ABL1 on the IS. We conclude that detection of e1a2, b2a2, b3a2 and ABL1 can be achieved in a multiplex assay format compatible with IS reporting. Further clinical validation of the assay could improve the operational efficiency of clinical laboratories, increase their adherence to current recommendations for b2a2/b3a2 reporting on the IS and provide for the first time an opportunity to standardize e1a2-monitoring results.
机译：准确，标准化的BCR-ABL1定量检测方法是监测t（9; 22）阳性白血病治疗反应的前提。在这里，我们描述了一种基于经过验证的TaqMan和Armored RNA技术的新型多重测定系统，并针对单个反应中的三个BCR–ABL1融合转录本和ABL1的灵敏检测进行了优化。分析实验证实了同时进行的扩增反应之间没有明显的竞争，并建立了测定的灵敏度，线性和精密度。与115个临床标本进行的比较研究与常规在临床测试中使用的独立的单重实验室开发的测试产生了高质量和定量的一致性。与已校准为国际标准（IS）的参考实验室的直接比较显示，方法之间的分析偏差最小，并且在IS上定量测量BCR–ABL1所需的性能范围内，其总体准确性和精密度。我们得出的结论是，可以以与IS报告兼容的多重分析格式实现对e1a2，b2a2，b3a2和ABL1的检测。该测定法的进一步临床验证可以提高临床实验室的运营效率，增加其对IS上b2a2 / b3a2报告的最新建议的依从性，并首次为标准化e1a2监测结果提供了机会。

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