M Poljak1, A Oštrbenk Valenčak2, G Gimpelj Domjanič2, L Xu3, M Arbyn3. 1. Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. Electronic address: mario.poljak@mf.uni-lj.si. 2. Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. 3. Belgian Cancer Centre, Unit of Cancer Epidemiology, Sciensano, Brussels, Belgium.
Abstract
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.
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.
Authors: Brhanu Teka; Muluken Gizaw; Ededia Firdawoke; Adamu Addissie; Tesfamichael Awoke Sisay; Carola Schreckenberger; Anna Sophie Skof; Sarah Thies; Adane Mihret; Eva Johanna Kantelhardt; Tamrat Abebe; Andreas M Kaufmann Journal: Cancer Manag Res Date: 2022-07-29 Impact factor: 3.602
Authors: Stephanie S Liu; Karen K L Chan; Tina N Wei; Ka Yu Tse; Siew F Ngu; Mandy M Y Chu; Lesley S K Lau; Annie N Y Cheung; Hextan Y S Ngan Journal: PLoS One Date: 2022-08-05 Impact factor: 3.752