Center for Cervical Cancer Elimination, Department of Clinical Pathology and Cancer Diagnostics, Medical Diagnostics Karolinska, Karolinska University Hospital, Huddinge, Stockholm, Sweden; Division for Cervical Cancer Elimination, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Division for Cervical Cancer Elimination, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
J Clin Virol. 2023 Oct;167:105581. doi: 10.1016/j.jcv.2023.105581. Epub 2023 Sep 4.
Although cervical screening using Human Papillomavirus (HPV) testing is globally recommended public health policy, there has been no international proficiency studies specifically targeting HPV testing for cervical screening.
To obtain the first global overview of the current proficiency of HPV testing services for cervical cancer screening.
A coded proficiency panel of 12 samples containing HPV types 16, 18, 31, 33, 45, 52, 58 or 35/39/51/56/59/68 in human DNA in varying amounts as well as control. Datasets detecting at least a) 10 International Units (IU) of HPV16 and 18, b) 1000 IU of HPV types 31, 33, 45, 52, 58 and c) having no false positives were considered proficient.
In total, 84 laboratories worldwide submitted 158 datasets (some laboratories used >1 HPV testing platform). Of those, 122 (77%) were 100% proficient. Only 14/158 datasets (9%) contained false positive results. Comparison of results with assays approved by the Food and Drug Administration (FDA) suggest that future proficiency requirements should also accommodate assays detecting only 100 IU of HPV16/18. A pool of low oncogenicity HPV types that contributed very little to sensitivity, but adversely affected specificity, was detectable by most datasets.
Internationally recognized proficiency studies of HPV screening, traceable to international standards, provided an overview of current testing performance. There was a high level of proficiency in terms of sensitivity and few false positives, but specificity was not optimal and further research on optimal specificity of HPV screening tests may be warranted.
虽然全球推荐采用人乳头瘤病毒（HPV）检测进行宫颈筛查，但针对 HPV 检测用于宫颈筛查的国际能力研究尚属空白。
全面了解当前 HPV 检测用于宫颈癌筛查的能力现状。
采用含有人 DNA 中的 HPV 16、18、31、33、45、52、58 型或 35/39/51/56/59/68 型 12 种样本的编码能力检测面板，每种样本的 HPV 载量不同，并设有对照样本。能准确检出 a）至少 10 国际单位（IU）的 HPV16 和 18；b）至少 1000IU 的 HPV 31、33、45、52、58；c）无假阳性的检测数据集被认为是能力合格的。
全球共有 84 家实验室提交了 158 个数据集（部分实验室使用了＞1 种 HPV 检测平台），其中 122 个（77%）实验室的能力为 100%合格。仅有 14/158 个数据集（9%）存在假阳性结果。与美国食品和药物管理局（FDA）批准的检测方法进行比较的结果表明，未来的能力要求还应包括能检测到 100IU HPV16/18 的检测方法。大多数数据集能检测到低致癌性 HPV 型，这些 HPV 型对敏感性的贡献很小，但会降低特异性。
通过可溯源至国际标准的 HPV 筛查国际公认能力研究，提供了当前检测性能的概述。在敏感性方面能力水平较高，假阳性较少，但特异性并不理想，可能需要进一步研究 HPV 筛查检测的最佳特异性。
