Establishment and Validation of Analytical Reference Panels for the Standardization of Quantitative BCR-ABL1 Measurements on the International Scale
Establishment and Validation of Analytical Reference Panels for the Standardization of Quantitative BCR-ABL1 Measurements on the International Scale
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DOI：
10.1373/clinchem.2012.196477
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发表时间：
2013-06-01
影响因子：
9.3
通讯作者：
Labourier, Emmanuel
中科院分区：
文献类型：
--
作者：
White, Helen E.;Hedges, John;Labourier, Emmanuel
背景技术背景：目前用于管理费城阳性慢性髓细胞白血病的指南包括通过定量逆转录PCR（RT-qPCR）监测BCR-ABL 1（断点簇区/c-abl癌基因1，非受体酪氨酸激酶）融合基因的表达。我们的目标是建立和验证参考面板，以减轻实验室间定量BCR-ABL 1测量的不精确性，并促进全球标准化的国际规模（IS）。方法：四级二级参考面板的控制和验证过程下制造的合成装甲RNA定量分子（Asuragen）校准的参考标准，从世界卫生组织和NIST。在IS参考实验室和非IS标准化的RT-qPCRmethods.RESULTS：对于大多数方法，BCR-ABL 1 e13 a2和e14 a2相对于ABL 1或BCR的百分比比值在4个不同水平下稳健，线性超过3 μ ms，从IS的10%到0.01%。批内和批间不精密度为
BACKGROUND: Current guidelines for managing Philadelphia-positive chronic myeloid leukemia include monitoring the expression of the BCR-ABL1 (breakpoint cluster region/c-abl oncogene 1, nonreceptor tyrosine kinase) fusion gene by quantitative reverse-transcription PCR (RT-qPCR). Our goal was to establish and validate reference panels to mitigate the interlaboratory imprecision of quantitative BCR-ABL1 measurements and to facilitate global standardization on the international scale (IS).METHODS: Four-level secondary reference panels were manufactured under controlled and validated processes with synthetic Armored RNA Quant molecules (Asuragen) calibrated to reference standards from the WHO and the NIST. Performance was evaluated in IS reference laboratories and with non-IS-standardized RT-qPCR methods.RESULTS: For most methods, percent ratios for BCR-ABL1 e13a2 and e14a2 relative to ABL1 or BCR were robust at 4 different levels and linear over 3 logarithms, from 10% to 0.01% on the IS. The intraassay and interassay imprecision was