Deans Zandra C, Tull Justyna, Beighton Gemma, Abbs Stephen, Robinson David O, Butler Rachel
UK NEQAS for Molecular Genetics, Institute of Human Genetics, International Centre for Life, Central Parkway, Newcastle upon Tyne, United Kingdom.
Genet Test Mol Biomarkers. 2011 Nov;15(11):777-83. doi: 10.1089/gtmb.2010.0239. Epub 2011 Aug 18.
Laboratories are increasingly required to perform molecular tests for the detection of mutations in the KRAS gene in metastatic colorectal cancers to allow better clinical management and more effective treatment for these patients. KRAS mutation status predicts a patient's likely response to the monoclonal antibody cetuximab. To provide a high standard of service, these laboratories require external quality assessment (EQA) to monitor the level of laboratory output and measure the performance of the laboratory against other service providers. National External Quality Assurance Services for Molecular Genetics provided a pilot EQA scheme for KRAS molecular analysis in metastatic colorectal cancers during 2009. Very few genotyping errors were reported by participating laboratories; however, the reporting nomenclature of the genotyping results varied considerably between laboratories. The pilot EQA scheme highlighted the need for continuing EQA in this field which will assess the laboratories' ability not only to obtain accurate, reliable results but also to interpret them safely and correctly ensuring that the referring clinician has the correct information to make the best clinical therapeutic decision for their patient.
越来越多的实验室被要求对转移性结直肠癌进行KRAS基因突变检测的分子测试，以便为这些患者提供更好的临床管理和更有效的治疗。KRAS突变状态可预测患者对单克隆抗体西妥昔单抗的可能反应。为了提供高标准的服务，这些实验室需要外部质量评估（EQA）来监测实验室产出水平，并对照其他服务提供商衡量实验室的表现。国家分子遗传学外部质量保证服务机构在2009年为转移性结直肠癌的KRAS分子分析提供了一个试点EQA计划。参与实验室报告的基因分型错误很少；然而，各实验室之间基因分型结果的报告命名法差异很大。该试点EQA计划突出表明在这一领域持续进行EQA的必要性，这将评估实验室不仅获得准确、可靠结果的能力，还将评估其安全、正确解释结果的能力，确保转诊临床医生拥有正确信息，以便为其患者做出最佳临床治疗决策。
