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首页> 外文期刊>Annales de biologie clinique >Validation steps for the detection of L858R mutation in EGFR gene by real time quantitative PCR
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Validation steps for the detection of L858R mutation in EGFR gene by real time quantitative PCR

机译：实时定量PCR检测EGFR基因L858R突变的验证步骤

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摘要

Since January 16th 2010, the French legislation requires that the medical laboratories must be accredited according to ISO 15189 standards. This concerned all the biological medical technics, including molecular biology technics. In this work, we described the validation steps by real time quantitative PCR of L858R mutation in EGFR gene, frequently detected in non-small lung cancers (NSCLC). Epidermal growth factor - tyrosine kinase inhibitors (EGFR-TKIs) are authorized in Europe for the treatment of metastatic NSCLC after failure of, at least one, prior chemotherapy. Thus, in view of accreditation of this analysis, we have used the recommendation of the COFRAC (Comite franc, ais d'accreditation) and INCa (Institut national du cancer). Several parameters have been tested, such as the primers, the limit of detection, and the sensitivity and specificity of the method. In addition, a risk study has been evaluated. Although long and fastidious, the method of validation is required to perform analysis in optimal conditions to guaranty optimal results for the patients.
机译：自2010年1月16日起，法国立法要求必须根据ISO 15189标准对医学实验室进行认证。这涉及所有生物医学技术，包括分子生物学技术。在这项工作中，我们描述了通过实时定量PCR对EGFR基因中L858R突变的验证步骤，该突变通常在非小肺癌（NSCLC）中检测到。在欧洲，表皮生长因子酪氨酸激酶抑制剂（EGFR-TKIs）在至少一种先前的化疗失败后在欧洲被授权用于治疗转移性NSCLC。因此，鉴于对这一分析的认可，我们采用了COFRAC（法郎，ais d'accreditation）和INCa（国家癌症研究所）的建议。已经测试了几个参数，例如引物，检测限以及方法的灵敏度和特异性。此外，还对一项风险研究进行了评估。尽管冗长而挑剔，但仍需要使用验证方法在最佳条件下进行分析，以确保为患者提供最佳结果。

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