2023 global inventory of commercial molecular tests for human papillomaviruses (HPV)

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dynamic: 86 new distinct HPV tests (and 141 variants) were introduced and 76 tests (and 55 variants) were withdrawn from the market in the last four years.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.

Keywords: Cervical cancer; HPV; Human papillomaviruses; Screening; Test.