References
- Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A.
Global cancer statistics 2018: GLOBOCAN estimates of incidence and
mortality worldwide for 36 cancers in 185 countries [published
correction appears in CA Cancer J Clin. 2020
Jul;70(4):313]. CA Cancer J Clin . 2018;68(6):394-424.
doi:10.3322/caac.21492
- Lin S, Gao K, Gu S, et al. Worldwide trends in cervical cancer
incidence and mortality, with predictions for the next 15
years. Cancer . 2021;127(21):4030-4039. doi:10.1002/cncr.33795
- https://ictv.global/report/chapter/papillomaviridae/papillomaviridae
(Accessed 23 June 2023).
- Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human
papillomavirus and cervical cancer. Lancet .
2007;370(9590):890-907. doi:10.1016/S0140-6736(07)61416-0
- Bosch FX, de Sanjosé S. The epidemiology of human papillomavirus
infection and cervical cancer. Dis Markers . 2007;23(4):213-227.
doi:10.1155/2007/914823
- Schiffman M, Wentzensen N, Wacholder S, Kinney W, Gage JC, Castle PE.
Human papillomavirus testing in the prevention of cervical
cancer. J Natl Cancer Inst . 2011;103(5):368-383.
doi:10.1093/jnci/djq562
- Ronco G, Dillner J, Elfström KM, et al. Efficacy of HPV-based
screening for prevention of invasive cervical cancer: follow-up of
four European randomised controlled trials [published correction
appears in Lancet. 2015 Oct 10;386(10002):1446]. Lancet .
2014;383(9916):524-532. doi:10.1016/S0140-6736(13)62218-7
- Bhatla N, Singhal S. Primary HPV screening for cervical
cancer. Best Pract Res Clin Obstet Gynaecol . 2020;65:98-108.
doi:10.1016/j.bpobgyn.2020.02.008
- Cuzick J, Clavel C, Petry KU, et al. Overview of the European and
North American studies on HPV testing in primary cervical cancer
screening. Int J Cancer . 2006;119(5):1095-1101.
doi:10.1002/ijc.21955
- Schiffman M, Doorbar J, Wentzensen N, et al. Carcinogenic human
papillomavirus infection. Nat Rev Dis Primers . 2016;2:16086.
Published 2016 Dec 1. doi:10.1038/nrdp.2016.86
- Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM.
Performance of carcinogenic human papillomavirus (HPV) testing and
HPV16 or HPV18 genotyping for cervical cancer screening of women aged
25 years and older: a subanalysis of the ATHENA study. Lancet
Oncol . 2011;12(9):880-890. doi:10.1016/S1470-2045(11)70188-7
- Arbyn M, Ronco G, Anttila A, et al. Evidence regarding human
papillomavirus testing in secondary prevention of cervical cancer
[published correction appears in Vaccine. 2013 Dec
16;31(52):6266]. Vaccine . 2012;30 Suppl 5:F88-F99.
doi:10.1016/j.vaccine.2012.06.095
- Maver PJ, Poljak M. Primary HPV-based cervical cancer screening in
Europe: implementation status, challenges, and future
plans. Clin Microbiol Infect . 2020;26(5):579-583.
doi:10.1016/j.cmi.2019.09.006
- Perkins RB, Guido RS, Castle PE, et al. 2019 ASCCP Risk-Based
Management Consensus Guidelines: Updates Through 2023. J Low
Genit Tract Dis . 2024;28(1):3-6. doi:10.1097/LGT.0000000000000788
- Perkins RB, Guido RS, Castle PE, et al. 2019 ASCCP Risk-Based
Management Consensus Guidelines for Abnormal Cervical Cancer Screening
Tests and Cancer Precursors [published correction appears in J Low
Genit Tract Dis. 2020 Oct;24(4):427]. J Low Genit Tract Dis .
2020;24(2):102-131. doi:10.1097/LGT.0000000000000525
- Perkins RB, Wentzensen N, Guido RS, Schiffman M. Cervical Cancer
Screening: A Review. JAMA . 2023;330(6):547-558.
doi:10.1001/jama.2023.13174
- Giorgi Rossi P, Carozzi F, Ronco G, et al. p16/ki67 and E6/E7 mRNA
Accuracy and Prognostic Value in Triaging HPV DNA-Positive Women
[published correction appears in J Natl Cancer Inst. 2021 Jul
17;:]. J Natl Cancer Inst . 2021;113(3):292-300.
doi:10.1093/jnci/djaa105
- Premarket Approval (PMA). Available online:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190
024 (Accessed 12 May 2023)
- Wentzensen N, Schiffman M, Palmer T, Arbyn M. Triage of HPV positive
women in cervical cancer screening. J Clin Virol . 2016;76 Suppl
1(Suppl 1):S49-S55. doi:10.1016/j.jcv.2015.11.015
- Zhang R, Ge X, You K, et al. p16/Ki67 dual staining improves the
detection specificity of high-grade cervical lesions. J Obstet
Gynaecol Res . 2018;44(11):2077-2084. doi:10.1111/jog.13760
- Wright TC Jr, Behrens CM, Ranger-Moore J, et al. Triaging HPV-positive
women with p16/Ki-67 dual-stained cytology: Results from a sub-study
nested into the ATHENA trial. Gynecol Oncol . 2017;144(1):51-56.
doi:10.1016/j.ygyno.2016.10.031
- Luttmer R, Dijkstra MG, Snijders PJ, et al. p16/Ki-67 dual-stained
cytology for detecting cervical (pre)cancer in a HPV-positive
gynecologic outpatient population. Mod Pathol .
2016;29(8):870-878. doi:10.1038/modpathol.2016.80
- Jach R, Mazurec M, Trzeszcz M, Zimmer M, Kedzia W, Wolski H. Cervical
cancer screening in Poland in current SARS-CoV-2 pandemic: Interim
guidelines of the Polish Society of Gynecologists and Obstetricians
and the Polish Society of Colposcopy and Cervical Pathophysiology - a
summary January 2021. Ginekol Pol . 2021;92(2):165-173.
doi:10.5603/GP.2021.0043
- Monaghan TF, Rahman SN, Agudelo CW, et al. Foundational Statistical
Principles in Medical Research: Sensitivity, Specificity, Positive
Predictive Value, and Negative Predictive Value. Medicina
(Kaunas) . 2021;57(5):503. Published 2021 May 16.
doi:10.3390/medicina57050503
- Trevethan R. Sensitivity, Specificity, and Predictive Values:
Foundations, Pliabilities, and Pitfalls in Research and
Practice. Front Public Health . 2017;5:307. Published 2017 Nov
20. doi:10.3389/fpubh.2017.00307
- Trzeszcz M, Mazurec M, Jach R, et al. p16/Ki67 dual stain triage
versus cytology in primary human papillomavirus-based cervical cancer
screening with limited genotyping. J Med Virol .
2023;95(11):e29271. doi:10.1002/jmv.29271
- Mazurec K, Trzeszcz M, Mazurec M, Streb J, Halon A, Jach R. Triage
Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based
Cervical Cancer Screening: p16/Ki67 Dual Stain vs.
Cytology. Cancers (Basel) . 2023;15(20):5095. Published 2023 Oct
21. doi:10.3390/cancers15205095
- Trzeszcz M, Mazurec M, Jach R, et al. Is Primary HPV with Secondary
p16/Ki67 Dual-Stain an Alternative HSIL-Risk Detection Strategy in
Cervical Cancer Screening for Women under 30 Years?. Diagnostics
(Basel) . 2021;11(11):2012. Published 2021 Oct 29.
doi:10.3390/diagnostics11112012
- Trzeszcz M, Mazurec M, Jach R, et al. Liquid-Based Screening Tests
Results: HPV, Liquid-Based Cytology, and P16/Ki67 Dual-Staining in
Private-Based Opportunistic Cervical Cancer
Screening. Diagnostics (Basel) . 2021;11(8):1420. Published 2021
Aug 5. doi:10.3390/diagnostics11081420
- Loghavi S, Walts AE, Bose S. CINtec® PLUS dual immunostain: a triage
tool for cervical pap smears with atypical squamous cells of
undetermined significance and low grade squamous intraepithelial
lesion. Diagn Cytopathol . 2013;41(7):582-587.
doi:10.1002/dc.22900
- National Cervical Cancer Screening Programme in Poland Coordinating
Centre; Polish Gynaecological Society; Polish Society of Pathologists;
Polish Society of Colposcopy and Uterine Cervix Pathology. Management
of abnormal pap smear–consensus guidelines of the National Cervical
Cancer Screening Programme in Poland Coordinating Centre, the Polish
Gynaecological Society, the Polish Society of Pathologists, and Polish
Society of Colposcopy and Uterine Cervix Pathology. Ginekol
Pol . 2009;80(2):129-138.
- Krajowa Izba Diagnostów Laboratoryjnych; Polskie Towarzystwo
Ginekologiczne. Wytyczne dotyczace aplikacji testów molekularnych
identyfikujacych DNA HPV HR w profilaktyce szyjki macicy. Stanowisko
ekspertów PTG i KIDL [Guidelines for application of molecular tests
identyfying HR HPV DNA in the prevention of cervical cancer. Statement
of experts from PGS (PTG) and NCLD (KIDL)]. Ginekol Pol .
2013;84(5):395-399.
- Massad LS, Einstein MH, Huh WK, et al. 2012 updated consensus
guidelines for the management of abnormal cervical cancer screening
tests and cancer precursors. Obstet Gynecol .
2013;121(4):829-846. doi:10.1097/AOG.0b013e3182883a34
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human
papillomavirus testing for cervical cancer screening: interim clinical
guidance. Obstet Gynecol . 2015;125(2):330-337.
doi:10.1097/AOG.0000000000000669
- Darragh TM, Colgan TJ, Thomas Cox J, et al. The Lower Anogenital
Squamous Terminology Standardization project for HPV-associated
lesions: background and consensus recommendations from the College of
American Pathologists and the American Society for Colposcopy and
Cervical Pathology [published correction appears in Int J Gynecol
Pathol. 2013 Jul;32(4):432] [published correction appears in Int J
Gynecol Pathol. 2013 Mar;32(2):241]. Int J Gynecol Pathol .
2013;32(1):76-115. doi:10.1097/PGP.0b013e31826916c7
- Kurman RJ, Carcangiu ML, Herrington CS. WHO Classification of
Tumours of Female Reproductive Organs , 4th ed.; International Agency
for Research on Cancer (IARC): Lyon, France, 2014.
- Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of
binary medical diagnostic tests for paired designs. Biometrics .
2000;56(2):345-351. doi:10.1111/j.0006-341x.2000.00345.x
- Hamers FF, Poullié AI, Arbyn M. Updated evidence-based recommendations
for cervical cancer screening in France. Eur J Cancer Prev .
2022;31(3):279-286. doi:10.1097/CEJ.0000000000000701
- Wright TC Jr, Stoler MH, Ranger-Moore J, et al. Clinical validation of
p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results
from the IMPACT trial. Int J Cancer . 2022;150(3):461-471.
doi:10.1002/ijc.33812
- Øvestad IT, Dalen I, Andersland MS, et al. Triaging HPV-Positive
Cervical Samples with p16 and Ki-67 Dual Stained Cytology within an
Organized Screening Program-A Prospective Observational Study from
Western Norway. Int J Mol Sci . 2023;24(8):7158. Published 2023
Apr 12. doi:10.3390/ijms24087158
- Naucler P, Ryd W, Törnberg S, et al. Efficacy of HPV DNA testing with
cytology triage and/or repeat HPV DNA testing in primary cervical
cancer screening. J Natl Cancer Inst . 2009;101(2):88-99.
doi:10.1093/jnci/djn444
- El-Zein M, Bouten S, Louvanto K, et al. Predictive Value of HPV
Testing in Self-collected and Clinician-Collected Samples Compared
with Cytology in Detecting High-grade Cervical Lesions. Cancer
Epidemiol Biomarkers Prev . 2019;28(7):1134-1140.
doi:10.1158/1055-9965.EPI-18-1338
- McGee AE, Alibegashvili T, Elfgren K, et al. European consensus
statement on expert colposcopy. Eur J Obstet Gynecol Reprod
Biol . 2023;290:27-37. doi:10.1016/j.ejogrb.2023.08.369