Department of Haematology, Institute of Clinical Pathology and Medical Research ICPMR, Pathology West, Westmead Hospital, Westmead, New South Wales 2145, Australia.
Semin Thromb Hemost. 2013 Apr;39(3):235-49. doi: 10.1055/s-0033-1336833. Epub 2013 Mar 12.
The diagnostic or test-performance process, as associated to the evaluation or diagnosis of hemostasis and thrombosis and related disorders, is influenced or controlled by the activity of a large number of professional, expert, and government organizations. These may be involved in driving standardization or harmonization, providing professional or expert guidelines, or in regulation of therapeutic products and diagnostic products such as in vitro diagnostic devices or reagents (IVDs). Although all organizations involved in this activity would propose an intention to drive improvements in diagnostics and human health and although there are benefits to the overall process of standardization and regulation for tests of hemostasis and thrombosis, it should also be recognized there are several specific problems and limitations to this process. As highlighted in this report, which specifically relates to the regulation of IVDs, several case studies are used as examples to show that regulation, aimed to reduce risks associated with the implementation of diagnostic testing, may instead encourage the adverse outcome of locking out clinically useful, new, and improved technologies and locking in old and outdated technologies. This has a potential for significant adverse outcomes related to the clinical diagnosis and management of hemostasis and thrombosis-related disorders.
诊断或检测性能过程与止血和血栓形成及相关疾病的评估或诊断相关，受到许多专业、专家和政府组织的活动的影响或控制。这些组织可能参与推动标准化或协调化、提供专业或专家指南，或者对治疗产品和诊断产品（如体外诊断设备或试剂）进行监管。虽然所有参与这一活动的组织都提议旨在提高诊断和人类健康，但尽管止血和血栓形成检测的标准化和监管过程带来了整体益处，但也应该认识到这一过程存在一些具体问题和局限性。正如本报告特别针对体外诊断设备的监管所强调的那样，使用了几个案例研究作为示例，表明旨在降低与诊断测试实施相关的风险的监管可能反而会鼓励淘汰临床上有用、新的和改进的技术，而锁定旧的和过时的技术。这可能对止血和血栓形成相关疾病的临床诊断和管理产生重大不利后果。
