Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth St Melbourne, 3000, Australia.
Department of Microbiology and Immunology, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Microb Genom. 2023 Aug;9(8). doi: 10.1099/mgen.0.001097.
Pathogen genomics has transitioned rapidly from the research setting into a powerful tool now routinely used in public health microbiology, for surveillance, outbreak investigations and disease control. As these investigations can have significant public health, treatment and legal impacts, we must ensure the accuracy of these results through validation of testing processes. For laboratories working in this space, it is important to approach this work with a quality and accreditation framework in mind, working towards implementation of quality systems and test validation that meet international regulatory standards. Here we outline the key international standards and processes that lead toward accreditation for pathogen genomics.
病原微生物基因组学已迅速从研究领域转变为公共卫生微生物学中常用的强大工具，用于监测、暴发调查和疾病控制。由于这些调查可能对公共卫生、治疗和法律产生重大影响，我们必须通过验证测试过程来确保这些结果的准确性。对于从事这一领域工作的实验室来说，重要的是在考虑质量和认证框架的情况下开展这项工作，努力实施符合国际监管标准的质量体系和测试验证。在这里，我们概述了通向病原微生物基因组学认证的关键国际标准和流程。
