个体化医学检验室间质量评价计划的建立与应用

Establishment and application of external quality assessment programs for personalized medical diagnostic tests

以分子诊断技术为依托的个体化医学检测发展迅猛。癌症、遗传学、药物基因组学及微生物检测等项目相继在临床实验室开展并在个体化医疗中发挥着越来越重要的作用。临床分子诊断结果的准确可靠是真正实现个体化医疗的首要前提。室间质量评价(EQA)计划的实施是确保个体化医学检测结果准确、可靠的有效措施之一。如何科学地建立分子诊断EQA计划,及时地开发出新的EQA项目并覆盖分子检测全过程是今后分子诊断质量监管的重点。

Personalized medical diagnostic tests which mainly rely on molecular diagnostic technology have developed rapidly in recent years. Medical tests related to cancer,genetics,pharmacogenomics and microbial determination have been successively carried out in many clinical laboratories and play roles in personalized medical treatments. Accurate and reliable clinical diagnostic results are important for personalized healthcare,and external quality assessment（EQA） program is one of the most effective approaches to ensure the accuracy and reliability of medical tests＇ results. Establishing EQA programs for molecular diagnostic tests scienti？cally,developing a new EQA program in time and covering the whole process are focuses for the quality supervision of molecular diagnostic tests.