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关于国内临床分子诊断发展的若干思考

摘要

Molecular diagnostics is now playing an increasingly important role in the diagnosis , prognosis and therapeutic monitoring of diseases .However, the molecular diagnostic practices in China are still lagging far behind those in the western countries , such as levels of testing platform , test diversity , quality control , result interpretation and administration of laboratory developed tests .Here we compared the current situation of molecular diagnostics in China with the daily work flow in the advanced countries , appealing for the collaboration of governmen administrators , professional associations and clinical laboratories to establish the appropriate supervising policies , technical guides and quality control standards of molecular diagnostic tests .On the premise of an ensured test result , the opening up of clinical test administration will effectively accelerate the development of molecular diagnostics .%分子诊断已经广泛地应用于疾病的诊断、预后判断和疗效检测中,但与国外水平相比,现行的国内分子诊断无论在检测平台和项目、质控措施上,还是在结果解释和自建项目的监管上都存在较大的差距,本文比较了国内外分子诊断的现状,希望能够藉此呼吁政府、行业学会和实验室三方共同来制定相关政策、行业规范和质量控制的文件,在保证临床基因扩增检验质量的前提下,开展更多的分子诊断试验,推进国内临床分子诊断发展。

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