A comparability study of 5 commercial KRAS tests
A comparability study of 5 commercial KRAS tests
复制标题
DOI：
10.1186/1746-1596-5-23
复制
发表时间：
2010-04-16
影响因子：
2.6
通讯作者：
Patterson, Scott D.
中科院分区：
文献类型：
--
作者：
Oliner, Kelly;Juan, Todd;Patterson, Scott D.
背景资料：KRAS基因的激活突变经常发生在人类肿瘤中，包括结直肠癌;大多数突变发生在密码子12和13中。KRAS中的突变与对抗表皮生长因子受体抗体的不良反应相关。因此，需要对KRAS突变状态进行准确且易于获得的分析。本研究的目的是评估6个不同的laborators.Methods：福尔马林固定石蜡包埋的结直肠癌肿瘤样本进行KRAS测定之间的一致性。将样本切片提交至5个独立的商业实验室（Amstercourt、Gentris、Genzyme、HistoGeneX和Invitek）进行KRAS突变分析，并提交至安进DNA测序实验室进行直接聚合酶链反应测序。Invitek使用的检测试剂盒不再市售，已被替代技术取代。将商业服务的结果与Amgen直接测序的结果进行比较。结果：在Amgen直接测序测定中，在40个样品中的20个（50%）中在密码子12和/或13中观察到KRAS突变。HistoGeneX（kappa = 0.95）、Genzyme（kappa = 0.94）和Amstercourt（kappa = 0.94）的结果与这些结果几乎完全一致，Gentris的结果与安进的结果基本一致（kappa = 0.75）。Invitek等位基因特异性检测显示出轻微的一致性（kappa = 0.13）。结论：本研究提供了KRAS突变分析可比性的数据。结果表明，大多数（但不是所有）商业服务提供的分析准确且与直接测序相当。
Background: Activating mutations in the KRAS gene occur frequently in human tumors, including colorectal carcinomas; most mutations occur in codons 12 and 13. Mutations in KRAS have been associated with poor response to anti-epidermal growth factor receptor antibodies. Therefore, an accurate and readily available analysis of KRAS mutational status is needed. The aim of this study was to evaluate concordance between KRAS assays performed by 6 different laboratories.Methods: Forty formalin-fixed paraffin-embedded colorectal cancer tumor samples were obtained. Sample sections were submitted for KRAS mutation analysis to 5 independent commercial laboratories (Agencourt, Gentris, Genzyme, HistoGeneX, and Invitek) and to the Amgen DNA Sequencing Laboratory for direct polymerase chain reaction sequencing. The assay used by Invitek is no longer commercially available and has been replaced by an alternative technique. Results from the commercial services were compared with those from Amgen direct sequencing by. statistics.Results: KRAS mutations were observed in codon 12 and/or 13 in 20 of 40 (50%) samples in Amgen direct sequencing assays. Results from HistoGeneX (kappa = 0.95), Genzyme (kappa = 0.94), and Agencourt (kappa = 0.94) were in almost perfect agreement with these results, and the results from Gentris were in substantial agreement with the results from Amgen (kappa = 0.75). The Invitek allele-specific assay demonstrated slight agreement (kappa = 0.13).Conclusions: This study provides data on the comparability of KRAS mutational analyses. The results suggest that most (but not all) commercial services provide analysis that is accurate and comparable with direct sequencing.