Commercially available molecular tests for human papillomaviruses : a global overview

Poljak, Mario (author), Oštrbenk Valenčak, Anja (author), Gimpelj Domjanič, G. (author), Xu, Lan (author), Arbyn, Marc (author)

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.

• Language: English
• Keywords: cervical cancer, human papillomaviruses, commercial tests, HPV, screening
• Work type: Article
• Typology: 1.02 - Review Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2020
• Number of pages: Str. 1144-1150
• Numbering: Vol. 26, iss. 9
• PID: 20.500.12556/RUL-137785
• UDC: 618.1
• ISSN on article: 1198-743X
• DOI: 10.1016/j.cmi.2020.03.033
• COBISS.SI-ID: 27596547
• Publication date in RUL: 30.06.2022

POLJAK, Mario, OŠTRBENK VALENČAK, Anja, GIMPELJ DOMJANIČ, G., XU, Lan and ARBYN, Marc, 2020, Commercially available molecular tests for human papillomaviruses : a global overview. Clinical microbiology and infection [online]. 2020. Vol. 26, no. 9, p. 1144–1150. [Accessed 23 March 2025]. DOI 10.1016/j.cmi.2020.03.033. Retrieved from: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=eng&id=137785

Record is a part of a journal

• Title: Clinical microbiology and infection
• Publisher: Elsevier, European Society of Clinical Microbiology and Infectious Diseases
• ISSN: 1198-743X
• COBISS.SI-ID: 71154

Licences

• License: CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
• Link: http://creativecommons.org/licenses/by-nc-nd/4.0/
• Description: The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.

Secondary language

• Language: Slovenian
• Keywords: rak materničnega vratu, človeški papiloma virusi, komercialni testi