Department of Laboratory Medicine, Karolinska Institutet, Stockholm, 141 86, Sweden.
Department of Laboratory Medicine, Division of Medical Microbiology, Lund University, Lund, 221 85, Sweden.
J Clin Virol. 2022 Sep;154:105237. doi: 10.1016/j.jcv.2022.105237. Epub 2022 Jul 5.
Proficient Human Papillomavirus (HPV) genotyping services are essential to support HPV and cervical cancer elimination strategies, in particular to support HPV vaccine research.
To perform a global HPV genotyping proficiency study, with evaluation in relation to previous proficiency studies.
The proficiency panel contained 44 coded samples (40 samples containing one or more purified HPV types (HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b) in human DNA, 1 human DNA control and 3 DNA extraction controls). Proficiency required detection of both single and multiple infections of 50 International Units of HPV 16/18, of 500 genome equivalents for other HPV types and no false positivity.
One hundred and thirty-two laboratories submitted 211 datasets. Most assays used (182/211 datasets) were commercially available. An all-time high of 75% of the datasets were 100% proficient. One or more false positives were found in 17.5% of datasets. Among laboratories who participated in the 2019 proficiency study, full proficiency increased from 25% in 2019 to 60% in 2021. The high overall proficiency was mostly attributable to a large number of new laboratories, which used similar assays.
The worldwide deterioration in comparability and reliability of HPV testing found in 2019 is now reversed and an overall increase in proficiency is found.
熟练的人乳头瘤病毒（HPV）基因分型服务对于支持 HPV 和宫颈癌消除策略至关重要，特别是支持 HPV 疫苗研究。
进行全球 HPV 基因分型能力验证研究，并与以往的能力验证研究进行评估。
能力验证面板包含 44 个编码样本（40 个样本包含一个或多个纯化的 HPV 类型（HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b）在人 DNA 中，1 个人 DNA 对照和 3 个 DNA 提取对照）。能力验证要求检测 50IU 的 HPV16/18 的单一和多重感染，其他 HPV 类型的 500 个基因组当量，且无假阳性。
132 个实验室提交了 211 个数据集。使用最多的检测方法（211 个数据集中有 182 个）是商业可用的。有创纪录的 75%的数据集达到了 100%的能力验证标准。有 17.5%的数据集发现了一个或多个假阳性。在参加 2019 年能力验证研究的实验室中，完全能力验证从 2019 年的 25%增加到 2021 年的 60%。总体较高的能力验证主要归因于大量使用类似检测方法的新实验室。
2019 年发现的 HPV 检测可比性和可靠性的全球恶化情况现已扭转，并且整体能力验证水平有所提高。
