Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework

Abstract

The accuracy of high-risk human papillomavirus testing with the Xpert HPV assay on vaginal self-samples was compared with clinician-taken samples within the VALidation of HUman papillomavirus assays and collection DEvices for Self-samples and urine samples (VALHUDES) framework. Five-hundred and twenty-three women were recruited in five Belgian colposcopy clinics, of whom 483 (median age, 40 years; interquartile range, 31 to 49 years) were included in the main analysis (226 collected with Evalyn Brush and 257 collected with Qvintip). Cervical samples were collected with Cervex-Brush. Colposcopy and histology outcomes were considered as the reference standard. The Xpert HPV assay had similar accuracy for cervical intraepithelial neoplasia ≥2 on self-collected versus clinician-collected samples [relative sensitivity, 0.96 (95% CI, 0.91–1.02); and relative specificity, 0.96 (95% CI, 0.89–1.04)]. The relative accuracy slightly differed by vaginal collection device [sensitivity ratios of 0.98 (95% CI, 0.90–1.06) and 0.94 (95% CI, 0.87–1.02) for Evalyn and Qvintip, respectively; specificity ratios of 1.06 (95% CI, 0.95–1.19) and 0.88 (95% CI, 0.80–0.98) for Evalyn and Qvintip, respectively]. No difference in cycle threshold values was observed between vaginal and cervical samples. In conclusion, the sensitivity of Xpert HPV assay for cervical intraepithelial neoplasia ≥2 on vaginal self-samples was similar to that of cervical specimens. The clinical specificity was lower than on clinician-collected samples when self-samples were taken with Qvintip. The accuracy of high-risk human papillomavirus testing with the Xpert HPV assay on vaginal self-samples was compared with clinician-taken samples within the VALidation of HUman papillomavirus assays and collection DEvices for Self-samples and urine samples (VALHUDES) framework. Five-hundred and twenty-three women were recruited in five Belgian colposcopy clinics, of whom 483 (median age, 40 years; interquartile range, 31 to 49 years) were included in the main analysis (226 collected with Evalyn Brush and 257 collected with Qvintip). Cervical samples were collected with Cervex-Brush. Colposcopy and histology outcomes were considered as the reference standard. The Xpert HPV assay had similar accuracy for cervical intraepithelial neoplasia ≥2 on self-collected versus clinician-collected samples [relative sensitivity, 0.96 (95% CI, 0.91–1.02); and relative specificity, 0.96 (95% CI, 0.89–1.04)]. The relative accuracy slightly differed by vaginal collection device [sensitivity ratios of 0.98 (95% CI, 0.90–1.06) and 0.94 (95% CI, 0.87–1.02) for Evalyn and Qvintip, respectively; specificity ratios of 1.06 (95% CI, 0.95–1.19) and 0.88 (95% CI, 0.80–0.98) for Evalyn and Qvintip, respectively]. No difference in cycle threshold values was observed between vaginal and cervical samples. In conclusion, the sensitivity of Xpert HPV assay for cervical intraepithelial neoplasia ≥2 on vaginal self-samples was similar to that of cervical specimens. The clinical specificity was lower than on clinician-collected samples when self-samples were taken with Qvintip. Screening for nucleic acids of high-risk human papillomavirus (hrHPV) types, the causal agents of cervical cancer, is more effective than cytology and, therefore, recommended in most recent guidelines for secondary prevention of this neoplasia.1Arbyn M. Ronco G. Anttila A. Meijer C.J.L.M. Poljak M. Ogilvie G. Koliopoulos G. Naucler P. Sankaranarayanan R. Peto J. Evidence regarding human papillomavirus testing in secondary prevention of cervical cancer.Vaccine. 2012; 30: F88-F99Crossref PubMed Scopus (650) Google Scholar, 2Arbyn M. Gultekin M. Morice P. Nieminen P. Cruickshank M. Poortmans P. Kelly D. Poljak M. Bergeron C. Ritchie D. Schmidt D. Kyrgiou M. Van den Bruel A. Bruni L. Basu P. Bray F. Weiderpass E. The European response to the WHO call to eliminate cervical cancer as a public health problem.Int J Cancer. 2021; 148: 277-284Crossref PubMed Scopus (51) Google Scholar, 3Bouvard V. Wentzensen N. Mackie A. Berkhof J. Brotherton J. Giorgi-Rossi P. Kupets R. Smith R. Arrossi S. Bendahhou K. Canfell K. Chirenje Z.M. Chung M.H. del Pino M. de Sanjosé S. Elfström M. Franco E.L. Hamashima C. Hamers F.F. Herrington C.S. Murillo R. Sangrajrang S. Sankaranarayanan R. Saraiya M. Schiffman M. Zhao F. Arbyn M. Prendiville W. Indave Ruiz B.I. Mosquera-Metcalfe I. Lauby-Secretan B. The IARC perspective on cervical cancer screening.N Engl J Med. 2021; 385: 1908-1918Crossref PubMed Scopus (99) Google Scholar Moreover, human papillomavirus (HPV) assays can be applied on self-samples.4Arbyn M. Verdoodt F. Snijders P.J. Verhoef V.M. Suonio E. Dillner L. Minozzi S. Bellisario C. Banzi R. Zhao F.H. Hillemanns P. Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis.Lancet Oncol. 2014; 15: 172-183Abstract Full Text Full Text PDF PubMed Scopus (477) Google Scholar HPV testing on self-samples has gained worldwide attention because of its potential in reaching out to women who do not participate in or attend regular screening.5Arbyn M. Smith S.B. Temin S. Sultana F. Castle P. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses.BMJ. 2018; 363: k4823Crossref PubMed Scopus (411) Google Scholar,6Serrano B. Ibáñez R. Robles C. Peremiquel-Trillas P. de Sanjosé S. Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening.Prev Med. 2022; 154106900Crossref PubMed Scopus (66) Google Scholar As under-screened women remain at risk of developing cervical cancer, reaching out to this population has become a public health priority in many countries.6Serrano B. Ibáñez R. Robles C. Peremiquel-Trillas P. de Sanjosé S. Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening.Prev Med. 2022; 154106900Crossref PubMed Scopus (66) Google Scholar Randomized trials have demonstrated that offering a self-sample is more effective than traditional invitations to go to a clinic for collection of a cervical specimen by a health care professional.4Arbyn M. Verdoodt F. Snijders P.J. Verhoef V.M. Suonio E. Dillner L. Minozzi S. Bellisario C. Banzi R. Zhao F.H. Hillemanns P. Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis.Lancet Oncol. 2014; 15: 172-183Abstract Full Text Full Text PDF PubMed Scopus (477) Google Scholar,5Arbyn M. Smith S.B. Temin S. Sultana F. Castle P. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses.BMJ. 2018; 363: k4823Crossref PubMed Scopus (411) Google Scholar In addition, recent studies have shown that HPV testing on adequately prepared vaginal self-samples with a validated PCR-based HPV test has similar accuracy to detect cervical precancer as HPV testing on cervical specimens.5Arbyn M. Smith S.B. Temin S. Sultana F. Castle P. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses.BMJ. 2018; 363: k4823Crossref PubMed Scopus (411) Google Scholar The lack of international standardized protocols on self-samples has inspired the development of a framework for VALidation of HUman papillomavirus assays and collection DEvices for Self-samples and urine samples (VALHUDES).7Arbyn M. Peeters E. Benoy I. Vanden Broeck D. Bogers J. De Sutter P. Donders G. Tjalma W. Weyers S. Cuschieri K. Poljak M. Bonde J. Cocuzza C. Zhao F.H. Van Keer S. Vorsters A. VALHUDES: a protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples.J Clin Virol. 2018; 107: 52-56Crossref PubMed Scopus (62) Google Scholar Such standardized protocols and validation have existed for cervical samples for more than a decade.8Meijer C.J.L.M. Berkhof J. Castle P.E. Hesselink A.T. Franco E.L. Ronco G. Arbyn M. Bosch F.X. Cuzick J. Dillner J. Heideman D.A.M. Snijders P.J.F. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older.Int J Cancer. 2009; 124: 516-520Crossref PubMed Scopus (525) Google Scholar,9Arbyn M. Depuydt C. Benoy I. Bogers J. Cuschieri K. Schmitt M. Pawlita M. Geraets D. Heard I. Gheit T. Tommasino M. Poljak M. Bonde J. Quint W. VALGENT: a protocol for clinical validation of human papillomavirus assays.J Clin Virol. 2016; 76: S14-S21Crossref PubMed Scopus (112) Google Scholar About a dozen hrHPV DNA tests have been demonstrated to fulfil the international validation criteria on clinician samples, and the list of clinically validated tests is continuously expanding.10Arbyn M. Simon M. Peeters E. Xu L. Meijer C. Berkhof J. Cuschieri K. Bonde J. Ostrbenk Vanlencak A. Zhao F.H. Rezhake R. Gultekin M. Dillner J. de Sanjosé S. Canfell K. Hillemanns P. Almonte M. Wentzensen N. Poljak M. 2020 List of human papillomavirus assays suitable for primary cervical cancer screening.Clin Microbiol Infect. 2021; 27: 1083-1095Abstract Full Text Full Text PDF PubMed Scopus (99) Google Scholar Similar studies are necessary to tackle the existing challenges in HPV testing workflow on self-samples.11Arbyn M. Latsuzbaia A. Castle P.E. Sahasrabuddhe V.V. Broeck D.V. HPV testing of self-samples: influence of collection and sample handling procedures on clinical accuracy to detect cervical precancer.Lancet Reg Health Eur. 2022; 14100332PubMed Google Scholar Previous VALHUDES reports demonstrated that two assays [RealTime High Risk HPV assay (Abbott Molecular Diagnostics, Des Plaines, IL); and BD Onclarity HPV Assay (BD Diagnostics, Sparks, MD)] are similarly accurate to detect cervical precancer on vaginal self-samples and on first-void urine as on cervical clinician-taken samples.12Van Keer S. Peeters E. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Vorsters A. Arbyn M. Clinical and analytical evaluation of the RealTime high risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol.Gynecol Oncol. 2021; 162: 575-583Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar, 13Van Keer S. Latsuzbaia A. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Arbyn M. Vorsters A. Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: a diagnostic test accuracy Clin Virol. 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Tjalma W.A.A. Doyen J. Donders G. De Sutter P. Vorsters A. Peeters E. Arbyn M. Clinical performance of the high risk HPV assay on self-collected vaginal samples within the VALHUDES 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Donders G. Doyen J. Tjalma W. De Sutter P. Peeters E. Vorsters A. Arbyn M. of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES 2022; PubMed Scopus Google Scholar In the VALHUDES the analytical and clinical performance of the Xpert HPV assay a assay with on vaginal K. Geraets D. Cuzick J. L. C. Vanden Broeck D. E. Quint W. Arbyn M. of a assay for of clinically human papillomavirus (HPV) of HPV Clin 2016; PubMed Scopus Google Scholar The VALHUDES protocol M. Peeters E. Benoy I. Vanden Broeck D. Bogers J. De Sutter P. Donders G. Tjalma W. Weyers S. Cuschieri K. Poljak M. Bonde J. Cocuzza C. Zhao F.H. Van Keer S. Vorsters A. VALHUDES: a protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples.J Clin Virol. 2018; 107: 52-56Crossref PubMed Scopus (62) Google Scholar was to the relative clinical accuracy of HPV assays on self-collected vaginal and urine samples compared with HPV assays on clinician-taken samples, to the for of Accuracy as L. L. D. de guidelines for diagnostic accuracy and 2016; Scopus Google Scholar and women were because of existing HPV or cervical The of was 40 years range, 31 to 49 at five Belgian colposcopy of and and the The criteria were applied for the to and to and at the colposcopy clinics, to a vaginal self-sample with the vaginal device or Evalyn Brush the Cervical samples were collected by a using the in with European M. A. Nieminen P. J. E. J. Bergeron C. P. J. P. European guidelines for in cervical cancer for samples for and PubMed Scopus Google Scholar Colposcopy in and the offering the in and the Evalyn devices were when of the sample was The of the vaginal were at the colposcopy at the cervical samples were in collection by the samples were to for and within a of at the vaginal samples were samples were at for a of to by for to and were at HPV testing was on samples by of a of cervical and vaginal the Xpert The DNA and with for and HPV Xpert HPV is on a and of hrHPV was in five to the and were by The human was as sample for specimen and DNA HPV was cycle threshold was for and HPV and for HPV and were considered was P.E. Smith M.H. A. M.H. of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy J Clin PubMed Scopus Google Scholar The were applied for vaginal and cervical specimens. clinical accuracy the HPV testing on vaginal self-samples as the test and on cervical samples as the for reference colposcopy and histology outcomes were was and colposcopy was and not the was as cervical intraepithelial neoplasia In 483 women were included in the main (median age, 40 years; interquartile range, 31 to 49 women were the because of protocol as Keer S. Peeters E. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Vorsters A. Arbyn M. Clinical and analytical evaluation of the RealTime high risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol.Gynecol Oncol. 2021; 162: 575-583Abstract Full Text Full Text PDF PubMed Scopus (25) Google A. Vanden Broeck D. Van Keer S. Weyers S. Tjalma W.A.A. Doyen J. Donders G. De Sutter P. Vorsters A. Peeters E. Arbyn M. Clinical performance of the high risk HPV assay on self-collected vaginal samples within the VALHUDES 2022; PubMed Scopus Google Scholar cervical and five vaginal samples were because of of vaginal sample cervical and five vaginal samples were because of a on the vaginal sample was because of and relative performance of HPV testing were for the population and for women of years collected a vaginal with Evalyn Brush and collected a vaginal with the of the population were Keer S. Peeters E. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Vorsters A. Arbyn M. Clinical and analytical evaluation of the RealTime high risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol.Gynecol Oncol. 2021; 162: 575-583Abstract Full Text Full Text PDF PubMed Scopus (25) Google A. Vanden Broeck D. Van Keer S. Weyers S. Donders G. Doyen J. Tjalma W. De Sutter P. Peeters E. Vorsters A. Arbyn M. of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES 2022; PubMed Scopus Google Scholar The the test and to between cervical and vaginal samples. were to between the with the to to to to and to and were for hrHPV and genotyping as by the The in values between cervical and vaginal and between ≥2 and outcomes were with were using The VALHUDES was by the of the of of and the of the The was in with the of was Clinical sensitivity of Xpert HPV to detect ≥2 on vaginal self-samples collected with Evalyn Brush or was similar to cervical samples CI, 0.91–1.02); sensitivity to detect was lower CI, for on vaginal self-samples was not cervical samples CI, accuracy is in and of the Xpert HPV Assay on versus and sensitivity (95% of sensitivity (95% of specificity (95% of population Evalyn years Evalyn cervical intraepithelial samples collected with Evalyn Brush and in a cervical intraepithelial samples collected with Evalyn Brush and the analysis by vaginal sensitivity for ≥2 of Xpert HPV on Evalyn Brush CI, 0.90–1.06) and samples CI, 0.87–1.02) was similar to that for cervical samples. The of relative clinical sensitivity for ≥2 on Evalyn Brush versus was (95% CI, of Xpert HPV on Evalyn Brush samples was not cervical samples CI, on samples, specificity was lower CI, The specificity of Evalyn Brush versus was (95% CI, the analysis to women accuracy was slightly lower compared with the population and Xpert HPV hrHPV in of samples, and were hrHPV were on cervical samples and were on vaginal The observed to and test between cervical and vaginal with values to by device is shown in and and between Cervical and Brush (95% population ≥2 between the vaginal and cervical samples is as to to to to and to on vaginal and cervical on cervical on vaginal on sample cervical intraepithelial human high-risk in a The between the vaginal and cervical samples is as to to to to and to on vaginal and cervical on cervical on vaginal on sample cervical intraepithelial human high-risk values for of HPV and human DNA were lower for hrHPV and in women with ≥2 compared with in cervical samples No difference in values was by in vaginal samples and difference was observed in values between cervical and vaginal samples In this VALHUDES a similar analytical and clinical performance of Xpert HPV was demonstrated for ≥2 on vaginal self-samples versus clinician-taken samples. As clinical performance of hrHPV testing differed by vaginal A. Vanden Broeck D. Van Keer S. Weyers S. Tjalma W.A.A. Doyen J. Donders G. De Sutter P. Vorsters A. Peeters E. Arbyn M. Clinical performance of the high risk HPV assay on self-collected vaginal samples within the VALHUDES 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Donders G. Doyen J. Tjalma W. De Sutter P. Peeters E. Vorsters A. Arbyn M. of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES 2022; PubMed Scopus Google Scholar Xpert on Evalyn Brush was similarly more than on Qvintip. In the VALHUDES of RealTime High Risk HPV assay and BD Onclarity HPV Assay were assays similar sensitivity to detect ≥2 in vaginal self-samples compared with clinician-taken cervical samples, RealTime High Risk HPV assay of cycle to similar sensitivity on the vaginal self-samples compared with the clinician-taken A. Vanden Broeck D. Van Keer S. Weyers S. Tjalma W.A.A. Doyen J. Donders G. De Sutter P. Vorsters A. Peeters E. Arbyn M. Clinical performance of the high risk HPV assay on self-collected vaginal samples within the VALHUDES 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Donders G. Doyen J. Tjalma W. De Sutter P. Peeters E. Vorsters A. Arbyn M. of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES 2022; PubMed Scopus Google Scholar in accuracy between Evalyn and be by the device The Evalyn Brush has a collection has a with on the to the The Evalyn Brush more cervical compared with and, have been on the performance of HPV testing on In the updated by Arbyn M. Smith S.B. Temin S. Sultana F. Castle P. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses.BMJ. 2018; 363: k4823Crossref PubMed Scopus (411) Google Scholar accuracy studies were demonstrated similarly high accuracy of hrHPV tests to detect cervical precancer on vaginal self-samples as on clinician-collected samples the test was on validated PCR-based tests were on on that included studies with of PCR-based HPV tests on vaginal self-samples compared with cervical samples. that validated PCR-based hrHPV tests on cervical and vaginal high and values with the validation be extended to devices M. Castle P.E. Schiffman M. Wentzensen N. B. Sahasrabuddhe V.V. of in studies clinician-collected samples for HPV testing in cervical cancer J Cancer. 2022; PubMed Scopus Google Scholar validation of of HPV tests and self-sampling devices or and within the screening Xpert HPV has been validated for cervical cancer screening on cervical samples in within the of HPV M. Simon M. Peeters E. Xu L. Meijer C. Berkhof J. Cuschieri K. Bonde J. Ostrbenk Vanlencak A. Zhao F.H. Rezhake R. Gultekin M. Dillner J. de Sanjosé S. Canfell K. Hillemanns P. Almonte M. Wentzensen N. Poljak M. 2020 List of human papillomavirus assays suitable for primary cervical cancer screening.Clin Microbiol Infect. 2021; 27: 1083-1095Abstract Full Text Full Text PDF PubMed Scopus (99) Google K. Geraets D. Cuzick J. L. C. Vanden Broeck D. E. Quint W. Arbyn M. of a assay for of clinically human papillomavirus (HPV) of HPV Clin 2016; PubMed Scopus Google Scholar The Xpert assay was on cervical samples of women with and women recruited in a of screening and colposcopy in L. R. R. A. J. D. S. L. Clinical evaluation of to a human papillomavirus assay to its for cervical cancer screening in a diagnostic accuracy Full Text Full Text PDF PubMed Scopus Google Scholar The HPV to the specificity in the of women with because HPV and are in women than in the The that at risk to between sensitivity and a similar a on self-samples in the VALHUDES was not necessary because the accuracy on self-samples versus clinician samples was Keer S. Peeters E. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Vorsters A. Arbyn M. Clinical and analytical evaluation of the RealTime high risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol.Gynecol Oncol. 2021; 162: 575-583Abstract Full Text Full Text PDF PubMed Scopus (25) Google A. Vanden Broeck D. Van Keer S. Weyers S. Tjalma W.A.A. Doyen J. Donders G. De Sutter P. Vorsters A. Peeters E. Arbyn M. Clinical performance of the high risk HPV assay on self-collected vaginal samples within the VALHUDES 2022; PubMed Scopus Google Scholar R. L. A. R. J. C. D. S. L. of Xpert HPV on self-collected vaginal samples for cervical cancer screening women in 2021; PubMed Scopus Google Scholar similarly Xpert assay on self-samples women screening and colposcopy in as recommended for diagnostic accuracy Xpert was similarly on self-collected vaginal compared with clinician-taken cervical samples. is in with lower specificity was by R. L. A. R. J. C. D. S. L. of Xpert HPV on self-collected vaginal samples for cervical cancer screening women in 2021; PubMed Scopus Google Scholar In a women collected self-samples using was in of In two vaginal devices and were in of have in and, therefore, lower specificity was by and and have been by the and for cervical cancer screening on and were for and and and are to In VALHUDES hrHPV testing on vaginal samples using similar accuracy to hrHPV outcomes on clinician-collected cervical samples with the hrHPV tests are to detect DNA or are not necessary for HPV DNA In addition, the high of to extended validation are necessary to performance of the of screening in the use of self-samples has more is to necessary on the influence of and analytical on the clinical M. Latsuzbaia A. Castle P.E. Sahasrabuddhe V.V. Broeck D.V. HPV testing of self-samples: influence of collection and sample handling procedures on clinical accuracy to detect cervical precancer.Lancet Reg Health Eur. 2022; 14100332PubMed Google M. S. Latsuzbaia A. E. P. Cocuzza Basu P. Castle P.E. cervical cancer screening on self-samples in the challenges to women and test performance PubMed Scopus Google Scholar The Xpert HPV has been on to of prepared human and DNA and in five C. D. of for HPV testing at or the of 2021; Full Text Full Text PDF PubMed Scopus Google Scholar was compared with and and Xpert DNA was in and was the HPV DNA was in the in and, therefore, be to C. D. of for HPV testing at or the of 2021; Full Text Full Text PDF PubMed Scopus Google Scholar is to test on self-samples and clinician-collected samples. of with the Xpert HPV be a and effective for HPV testing with the Xpert is using a for DNA and and for and of HPV L. R. R. A. J. D. S. L. Clinical evaluation of to a human papillomavirus assay to its for cervical cancer screening in a diagnostic accuracy Full Text Full Text PDF PubMed Scopus Google Scholar are necessary to the HPV testing and human therefore, Xpert HPV be of in and its as a of the VALHUDES is that women were recruited in colposcopy clinics, in a high HPV and a Keer S. Peeters E. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Vorsters A. Arbyn M. Clinical and analytical evaluation of the RealTime high risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol.Gynecol Oncol. 2021; 162: 575-583Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar, 13Van Keer S. Latsuzbaia A. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Arbyn M. Vorsters A. Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: a diagnostic test accuracy Clin Virol. 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Tjalma W.A.A. Doyen J. Donders G. De Sutter P. Vorsters A. Peeters E. Arbyn M. Clinical performance of the high risk HPV assay on self-collected vaginal samples within the VALHUDES 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Donders G. Doyen J. Tjalma W. De Sutter P. Peeters E. Vorsters A. Arbyn M. of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES 2022; PubMed Scopus Google Scholar are in with similar diagnostic accuracy studies in colposcopy M. Smith S.B. Temin S. Sultana F. Castle P. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses.BMJ. 2018; 363: k4823Crossref PubMed Scopus (411) Google Scholar has been demonstrated that relative accuracy of HPV testing on self-samples compared with clinician-collected samples is in and screening M. Smith S.B. Temin S. Sultana F. Castle P. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses.BMJ. 2018; 363: k4823Crossref PubMed Scopus (411) Google Scholar relative accuracy has to be considered as a for diagnostic accuracy and of VALHUDES were in Keer S. Peeters E. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Vorsters A. Arbyn M. Clinical and analytical evaluation of the RealTime high risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol.Gynecol Oncol. 2021; 162: 575-583Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar, 13Van Keer S. Latsuzbaia A. Vanden Broeck D. De Sutter P. Donders G. Doyen J. Tjalma W.A.A. Weyers S. Arbyn M. Vorsters A. Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: a diagnostic test accuracy Clin Virol. 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Tjalma W.A.A. Doyen J. Donders G. De Sutter P. Vorsters A. Peeters E. Arbyn M. Clinical performance of the high risk HPV assay on self-collected vaginal samples within the VALHUDES 2022; PubMed Scopus Google Scholar, A. Vanden Broeck D. Van Keer S. Weyers S. Donders G. Doyen J. Tjalma W. De Sutter P. Peeters E. Vorsters A. Arbyn M. of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES 2022; PubMed Scopus Google Scholar hrHPV testing with the Xpert HPV on self-collected vaginal samples was similarly accurate to detect precancer as on clinician-collected cervical samples. Accuracy can be by the self-sampling

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