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2023年,对人类乳头瘤病毒 (HPV) 的商业分子测试进行全球清单

Mario Poljak¹, Anja Oštrbenk Valenčak¹, Kate Cuschieri²

¹Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

|March 22, 2024

概括

全球市场提供超过264个人类乳头瘤病毒 (HPV) 测试,但许多缺乏同行评审的数据. 在临床实践中使用的大量HPV测试具有未知的性能特征,构成风险.

科学领域:

病毒学和分子诊断病毒学和分子诊断
公共卫生和癌症查

背景情况:

商业人类乳头瘤病毒 (HPV) 测试对HPV社区至关重要,需要各种各样的产品,具有不同的性能特征.
之前在2010年,2012年,2015年和2020年的库存追踪了HPV分子测试的全球市场.

研究的目的:

从2023年12月起,在全球市场进行商业上可用的HPV分子测试的第五次清单.
评估HPV测试引入和撤回的动态格局,并评估支持其性能特征的证据.

主要方法:

数据收集涉及内部文件和对主要文献数据库和一般互联网的全面搜索,没有时间或语言限制.
在2023年12月进行了搜索,以确定全球可用的所有不同的HPV测试及其变体.

主要成果:

截至2023年12月,全球至少有264种不同的HPV测试 (511种变体),显示出从2020年开始的净增长.
这一时期出现了显著的市场动态:引入了86个新测试 (141个变体),取消了76个测试 (55个变体).
一个令人担忧的发现是,所有HPV测试的一半缺乏同行评审的出版物,79%缺乏符合社区标准的性能特征的证据.

结论:

只有很小一部分可用的HPV测试符合全球宫癌查挑战的严格要求.
许多商业HPV测试在临床实践和研究中使用了大部分未知的临床和分析性能特征,可能导致不良结果.
对于HPV测试制造商和更广泛的HPV社区来说,有很大的改进空间,以解决关于测试验证和证据的持久问题.

关键词:

宫癌是发生在宫癌的原因之一.这是一个HPVHPVHPV.人类乳头瘤病毒人类乳头瘤病毒.查检查查检查查检查测试测试测试测试测试

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