Commercially available molecular tests for human papillomaviruses : a global overview
ID Poljak, Mario (Author), ID Oštrbenk Valenčak, Anja (Author), ID Gimpelj Domjanič, G. (Author), ID Xu, Lan (Author), ID Arbyn, Marc (Author)

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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.

Keywords:cervical cancer, human papillomaviruses, commercial tests, HPV, screening
Work type:Article (dk_c)
Typology:1.02 - Review Article
Organization:MF - Faculty of Medicine
Publication status in journal:Published
Article version:Publisher's version of article
Number of pages:Str. 1144-1150
Numbering:Vol. 26, iss. 9
PID:20.500.12556/RUL-137785 This link opens in a new window
ISSN on article:1198-743X
DOI:10.1016/j.cmi.2020.03.033 This link opens in a new window
COBISS.SI-ID:27596547 This link opens in a new window
Publication date in RUL:30.06.2022
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Record is a part of a journal

Title:Clinical microbiology and infection
Publisher:Elsevier, European Society of Clinical Microbiology and Infectious Diseases
COBISS.SI-ID:71154 This link opens in a new window


License:CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
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

Keywords:rak materničnega vratu, človeški papiloma virusi, komercialni testi


Funder:EC - European Commission
Funding programme:FP7
Project number:603019
Name:Comparing health services interventions for the prevention of HPV-related cancer

Funder:EC - European Commission
Funding programme:H2020
Project number:847845
Name:Risk-based screening for cervical cancer

Funder:ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
Project number:P3-0083
Name:Odnosi parazitskega obstajanja

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