Mannhalter Christine
Klinisches Institut für Medizinische und Chemische Labordiagnostik, Medizinische Universität Wien, 1090 Wien, Osterreich.
Hamostaseologie. 2010 May;30(2):73-81.
Several challenges arise from the wide application of molecular genetic analyses, among them the need to introduce rules to evaluate molecular genetic test systems as well as test laboratories. This article specifically addresses laboratories performing molecular genetic tests for diagnosis, prevention and therapy of various diseases. The topics that will be discussed will support these laboratories to achieve and sustain a high quality and avoid mistakes and errors. The article covers important preanalytic, analytic and postanalytic aspects in regard to molecular genetic testing as well as quality management issues. In addition laboratory responsibilities, training of personnel, data protection issues, as well as informed consent aspects will be discussed. Beyond that, some molecular genetic methods will be dealt with in regard to potential quality criteria.
分子遗传学分析的广泛应用带来了若干挑战，其中包括需要引入规则来评估分子遗传学检测系统以及检测实验室。本文专门针对为各种疾病的诊断、预防和治疗进行分子遗传学检测的实验室。将要讨论的主题将支持这些实验室实现并维持高质量，避免失误和错误。本文涵盖了分子遗传学检测重要的分析前、分析中和分析后方面以及质量管理问题。此外，还将讨论实验室职责、人员培训、数据保护问题以及知情同意方面。除此之外，还将根据潜在的质量标准探讨一些分子遗传学方法。
