Implementation of Formalin-Fixed, Paraffin-Embedded Cell Line Pellets as High-Quality Process Controls in Quality Assessment Programs for KRAS Mutation Analysis
Implementation of Formalin-Fixed, Paraffin-Embedded Cell Line Pellets as High-Quality Process Controls in Quality Assessment Programs for KRAS Mutation Analysis
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DOI：
10.1016/j.jmoldx.2012.01.002
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发表时间：
2012-05-01
影响因子：
4.1
通讯作者：
van Krieken, J. Han J. M.
中科院分区：
文献类型：
--
作者：
Dijkstra, Jeroen R.;Opdam, Frank J. M.;van Krieken, J. Han J. M.
近年来，KRAS癌基因的突变状态已被纳入标准医疗保健，作为与转移性结直肠癌患者相关的治疗决策的预测指标。这是必要的，因为只有当肿瘤不携带KRAS突变时，这些患者才能受益于表皮生长因子受体（EGFR）靶向治疗，增加无进展生存期。许多不同的分析平台，包括商业上可用的和内部开发的，已经在病理实验室中用于评估KRAS突变状态。对于一个被认可进行此类测试的测试实验室来说，进行可靠性测试是至关重要的，但是以前不可能在不影响可重复性或对照样品的模仿的情况下对完整的工作流程进行大规模的此类测试。我们在欧洲9个实验室进行的一项盲法研究中评估了一种新的合成对照福尔马林固定石蜡包埋（FFPE）肿瘤样本。我们证明FFPE材料可以，至少部分地，模拟临床样本，我们证明这种控制是评估用于检测KRAS突变状态的平台的有价值的工具。[J] .医学诊断杂志2012；14:187-191;DOI: 10.1016/j.jmoldx.2012.01.002]。
In recent years, the mutational status of the KRAS oncogene has become incorporated into standard medical care as a predictive marker for therapeutic decisions related to patients with metastasized colorectal cancer. This is necessary, because these patients benefit from epidermal growth factor receptor (EGFR)-targeted therapy with increased progression-free survival only if the tumor does not carry a mutation in KRAS. Many different analytical platforms, both those commercially available and those developed in house, have been used within pathology laboratories to assess KRAS mutational status. For a testing laboratory to become accredited to perform such tests, it is essential that they perform reliability testing, but it has not previously been possible to perform this kind of testing on the complete workflow on a large scale without compromising reproducibility or the mimicry of the control sample. We assessed a novel synthetic control for formalin-fixed, paraffin-embedded (FFPE) tumor samples in a blind study conducted within nine laboratories across Europe. We show that FFPE material can, at least in part, mimic clinical samples and we demonstrate this control to be a valuable tool in the assessment of platforms used In testing for KRAS mutational status. (J Mal Diagn 2012; 14:187-191; DOI: 10.1016/j.jmoldx.2012.01.002).