Cuschieri Kate, Schuurman Rob, Coughlan Suzie
Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, Scotland.
HPV Research Group, University of Edinburgh, Edinburgh, Scotland.
Cytopathology. 2019 May;30(3):273-280. doi: 10.1111/cyt.12679. Epub 2019 Feb 18.
The increased use of human papillomavirus testing within cervical screening programmes necessarily brings about changes to the laboratory services required to support them. A crucial element of such services is to demonstrate initial and ongoing quality of the test (and associated processes). In this review, we outline some of the quality considerations and challenges with an emphasis on the laboratory including assay and platform validation, internal quality control selection and strengths and weaknesses of external quality assurance schemes. The influence and role of key external entities, including regulatory agencies, guideline groups, programme commissioners and commercial providers, are also discussed.
在子宫颈癌筛查计划中，人乳头瘤病毒检测的使用增加必然会给支持这些检测的实验室服务带来变化。此类服务的一个关键要素是证明检测（及相关流程）的初始质量和持续质量。在本综述中，我们概述了一些质量考量因素和挑战，重点是实验室方面，包括检测方法和平台验证、内部质量控制选择以及外部质量保证计划的优缺点。还讨论了包括监管机构、指南制定小组、项目委托方和商业供应商在内的关键外部实体的影响和作用。
