Abstract：
To suit the needs of the human papillomaviruses (HPV) community comprehensively, a range of commercial HPV tests with different performance characteristics are required. Four periodic inventories of commercial HPV molecular tests present in the global market were published previously in 2010, 2012, 2015 and 2020. For the fifth inventory, data were retrieved from internal files and a detailed search using the main bibliographic databases as well as general internet search without period or language restrictions was performed in December 2023. At least 264 distinct HPV tests (and 511 test variants) were available globally in December 2023. A small 2020-2023 net increase in total numbers was observed, but with a strong introduction/withdrawal dynamic: 86 new distinct HPV tests (and 141 variants) were introduced and 76 tests (and 55 variants) were withdrawn from the market in the last four years. Although quality improvement of some tests was recorded, half of all HPV tests are still without a single peer-reviewed publication, and 79 % of tests are without published evidence that demonstrate performance characteristics are in line with requirements agreed in the HPV community. Only a relatively small pool of tests fulfill the operational/performance characteristics required to meet the global cervical cancer screening challenge. Although clinical and analytical performance characteristics of many commercial HPV tests are largely unknown, such tests are used worldwide in daily clinical practice and research, with potentially deleterious consequences. Due to this long-lasting unfavorable situation, significant scope for improvement persists for both manufacturers of HPV tests and the HPV community.
摘要：
为了全面适应人类乳头瘤病毒（HPV）社区的需求，需要一系列具有不同性能特征的商业HPV检测.全球市场上存在的商业HPV分子检测的四个定期清单先前于2010年、2012年、2015年和2020年发布。对于第五个清单，2023年12月,我们从内部文件中检索了数据,并使用主要书目数据库进行了详细搜索,以及没有时期或语言限制的一般互联网搜索.2023年12月，全球至少有264种不同的HPV测试（和511种测试变体）可用。观察到2020-2023年总人数略有净增长，但具有强大的引入/退出动态:在过去四年中,引入了86个新的不同HPV测试(和141个变体),并从市场中撤出了76个测试(和55个变体).尽管记录了一些测试的质量改进，所有HPV检测的一半仍然没有经过同行评审的出版物，79%的检测没有发表的证据证明性能特征符合HPV社区同意的要求.只有相对较小的测试池满足满足全球宫颈癌筛查挑战所需的操作/性能特征。尽管许多商业HPV检测的临床和分析性能特征在很大程度上是未知的，此类测试在全球范围内用于日常临床实践和研究，潜在的有害后果。由于这种长期不利的局面，对于HPV检测的制造商和HPV社区来说,仍有显著的改善空间.
