Can REALQUALITY RQ-HPV screen be considered as a clinically validated HPV test for use in cervical cancer screening?

In a Letter-to-the-Editor, Gieffré and Iacobellis 1 Giuffre G. Iacobellis M. Re: ‘2020 list of human papillomavirus assays suitable for primary cervical cancer screening’ by Arbyn et al. Clin Microbiol Infect. 2023; x: x Google Scholar state that the REALQUALITY RQ-HPV Screen assay fulfills international criteria for HPV tests required for use in primary cervical cancer screening and is not an in-house test 2 Meijer C.J.L.M. Castle P.E. Hesselink A.T. et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009; 124: 516-520 Crossref PubMed Scopus (502) Google Scholar . We acknowledge that the validation outcomes mentioned in Giuffrè’s letter 1 Giuffre G. Iacobellis M. Re: ‘2020 list of human papillomavirus assays suitable for primary cervical cancer screening’ by Arbyn et al. Clin Microbiol Infect. 2023; x: x Google Scholar match with those in our 2020 review 3 Arbyn M. Simon M. Peeters E. et al. List of human papillomavirus assays suitable for primary cervical cancer screening. Clin Microbiol Infect. 2020; 27 (2021): 1083-1095 Abstract Full Text Full Text PDF Scopus (69) Google Scholar . We do therefore agree with their stipulation about the full validation status of REALQUALITY RQ-HPV Screen which is an HPV assay manufactured by a company, AB ANALITICA (Padua, Italy).