Adams Julia A, Post Kristin M, Bilbo Sarah A, Wang Xiaoyan, Sen Joyashree D, Cornwell Anita J, Malek Amanda J, Cheng Liang
Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, IN.
Appl Immunohistochem Mol Morphol. 2014 Mar;22(3):231-5. doi: 10.1097/PDM.0b013e3182a127f9.
The identification of KRAS mutations in patients with certain types of cancer, including colonic adenocarcinoma and non-small cell lung carcinoma, has become increasingly important as these patients are contraindicated from receiving epidermal growth factor receptor-targeted therapies. Several polymerase chain reaction (PCR)-based tests are commercially available for KRAS mutation testing including Applied Biosystems KRAS Mutation Analysis on the ABI3130xl, Qiagen therascreen KRAS RGQ PCR on the Rotor-Gene Q MDx, and Qiagen KRAS Pyro on the PyroMark Q24; however, these tests have not been compared side by side. The purpose of this study was to evaluate the performance characteristics and workflow for 3 PCR-based methods of detecting KRAS mutation status. We evaluated the performance characteristics and workflow for 3 commercially available KRAS mutation detection platforms. All of the 188 samples run were successful, with 29% being positive for the KRAS mutation. Of the positive tests, Applied Biosystems detected 84% of the positive cases, whereas Qiagen therascreen RGQ and Qiagen KRAS Pyro detected 100% of the positive cases. In cases of discrepancy between Applied Biosystems and therascreen RGQ, Pyro agreed with therascreen RGQ 95% of the time. Qiagen therascreen RGQ and Pyro were comparable in terms of sensitivity, specificity, positive predictive value, negative predictive value, and accuracy, with all values being 100%. All 3 techniques accurately identified the appropriate mutation in the known control specimens. In summary, all 3 tests are relatively comparable for detecting the KRAS mutation, with Applied Biosystems having a slightly lower sensitivity, negative predictive value, and accuracy than therascreen RGQ and Pyro.
在某些类型癌症患者中，包括结肠腺癌和非小细胞肺癌，KRAS突变的鉴定变得越来越重要，因为这些患者禁忌接受表皮生长因子受体靶向治疗。有几种基于聚合酶链反应（PCR）的检测方法可用于KRAS突变检测，包括应用生物系统公司在ABI3130xl上的KRAS突变分析、Qiagen公司在Rotor-Gene Q MDx上的therascreen KRAS RGQ PCR以及Qiagen公司在PyroMark Q24上的KRAS Pyro；然而，这些检测方法尚未进行过并列比较。本研究的目的是评估3种基于PCR的检测KRAS突变状态方法的性能特征和工作流程。我们评估了3种市售KRAS突变检测平台的性能特征和工作流程。所检测的188个样本全部成功，其中29%的样本KRAS突变呈阳性。在阳性检测结果中，应用生物系统公司检测出了84%的阳性病例，而Qiagen公司的therascreen RGQ和Qiagen公司的KRAS Pyro检测出了100%的阳性病例。在应用生物系统公司和therascreen RGQ结果存在差异的情况下，Pyro与therascreen RGQ的结果在95%的情况下一致。Qiagen公司的therascreen RGQ和Pyro在敏感性、特异性、阳性预测值、阴性预测值和准确性方面相当，所有值均为100%。所有3种技术都准确地鉴定出了已知对照样本中的适当突变。总之，在检测KRAS突变方面，所有3种检测方法相对可比，应用生物系统公司的敏感性、阴性预测值和准确性略低于therascreen RGQ和Pyro。
