Background

Molecular tests for detection of human papillomaviruses (HPVs) play a crucial role in the prevention of cervical cancer, including recently announced elimination efforts. HPV testing is a recommended approach for cervical cancer screening of women over 30 and for management of those with precancerous cervical lesions. In addition, they are widely used in epidemiological studies, HPV surveillance and vaccination impact monitoring.

Objectives

The aim was to provide an updated 2020 inventory of commercial molecular HPV tests available on the market.

Sources

Data were retrieved from internal files, and a detailed search using Medline/Pubmed, Web of Science, Scopus, Google Scholar, Google and Bing, without language or period restrictions, was performed in September 2019 and again in January 2020.

Content

We identified 254 distinct commercial HPV tests and at least 425 test variants available on the global market in 2020, which represents a 31% and 235% increase in the number of distinct tests and variants, respectively, compared with the previous inventory performed in 2015. Although the proportion of commercially available HPV tests with at least one peer-reviewed publication has increased over the past decade, 60% of the HPV tests on the global market are still without a single peer-reviewed publication. Furthermore, 82% of tests lack any published analytical and/or clinical evaluation, and over 90% are not evaluated in line with consensus requirements that ensure safe use in clinical settings.

Implications

Significant challenges and scope for improvement still exist for both the HPV scientific community and the manufacturers of HPV tests. The latter must put more effort into validating their products, in agreement with standardized procedures, including all steps of HPV testing and various clinical specimens. High throughput capacity and point-of-care HPV tests are needed, both with affordable prices.

中文翻译：

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人乳头瘤病毒的商业化分子检测：全球概述。

背景

用于检测人乳头瘤病毒（HPV）的分子检测在预防子宫颈癌中起着至关重要的作用，包括最近宣布的消除工作。HPV检测是推荐的方法，可用于筛查30岁以上女性的子宫颈癌和管理宫颈癌前病变的妇女。此外，它们还广泛用于流行病学研究，HPV监测和疫苗接种影响监测。

目标

目的是提供市场上可用的2020年更新的商业分子HPV检测清单。

资料来源

从内部文件中检索数据，并在2019年9月和2020年1月再次使用Medline / Pubmed，Web of Science，Scopus，Google Scholar，Google和Bing进行了详细搜索，没有语言或时间限制。

内容

我们确定了2020年全球市场上有254种不同的商业HPV测试和至少425种测试变体，与2015年进行的先前库存相比，不同测试和变体的数量分别增加了31％和235％。尽管在过去的十年中，至少有一份经过同行评审的出版物销售的商业HPV测试的比例有所增加，但全球市场上60％的HPV测试仍没有一份经过同行评审的出版物。此外，有82％的测试缺乏任何公开的分析和/或临床评估，超过90％的评估未符合确保在临床环境中安全使用的共识要求。

含义

HPV科学界和HPV测试制造商仍然面临重大挑战和改进范围。后者必须按照标准化程序，包括HPV测试的所有步骤和各种临床标本，在验证其产品上付出更多的努力。既需要高吞吐能力，又需要即时医疗HPV测试，且价格可承受。