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Published on: March 8, 2012
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Commercially available molecular tests for human papillomaviruses: a global overview
M Poljak1, A Oštrbenk Valenčak1, G Gimpelj Domjanič1
1Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Summary
The number of commercial human papillomavirus (HPV) tests has significantly increased, but many lack peer-reviewed validation. Further efforts are needed to ensure the quality and accessibility of HPV testing for cervical cancer prevention.
Area of Science:
- Molecular diagnostics
- Public health
- Oncology
Background:
- Molecular tests for human papillomaviruses (HPVs) are vital for cervical cancer prevention, screening, and surveillance.
- HPV testing is recommended for women over 30 and for managing precancerous cervical lesions.
- These tests are essential for epidemiological studies, HPV surveillance, and monitoring vaccination impact.
Purpose of the Study:
- To create an updated inventory of commercially available molecular HPV tests as of 2020.
- To document the growth and characteristics of the commercial HPV testing market.
Main Methods:
- Data collection involved internal records and comprehensive searches across multiple databases (Medline/PubMed, Web of Science, Scopus, Google Scholar, Google, Bing).
- Searches were conducted in September 2019 and January 2020, with no restrictions on language or publication period.
- The study identified distinct HPV tests and their variants available globally.
Main Results:
- In 2020, 254 distinct commercial HPV tests and 425 variants were identified, a substantial increase from 2015.
- Despite an increase in published studies, 60% of HPV tests lack peer-reviewed publications.
- A significant majority (82%) of tests lack published analytical/clinical evaluations, and over 90% are not assessed according to clinical safety standards.
Conclusions:
- Manufacturers must enhance product validation according to standardized procedures for all testing steps and clinical specimens.
- There is a need for high-throughput, point-of-care HPV tests that are also affordable.
- Addressing these challenges is crucial for the HPV scientific community and manufacturers to improve cervical cancer prevention efforts.
