References

ACOG 2020 Cervical Cancer Screening recommendations, available at https://www.acog.org/Patients/FAQs/Cervical-Cancer-Screening.

ACOG HPV Vaccination Information: Available at https://www.acog.org/store/products/patient-education/pamphlets/womens-health/human-papillomavirus-vaccination

American Cancer Society: HPV Vaccines: Updated, Available at https://www.cancer.org/cancer/cancer-causes/infectious-agents/hpv/hpv-vaccines.html

ATHENA HPV clinical trial. Roche website. Available at: https://diagnostics.roche.com/global/en/article-listing/athena-trial.html.

Basic information about cervical cancer. CDC website. Available at: http://www.cdc.gov/cancer/cervical/basic_info/.

Cancer Statistics: Cases, CDC, Available at https://www.cdc.gov/cancer/hpv/statistics/cases.htm.

CDC Guidelines Summary. Available at: https://www.cdc.gov/cancer/cervical/basic_info/screening.htm.

Cervical cancer. American Cancer Society website. Available at: http://www.cancer.org/cancer/cervicalcancer/index.

Cervical cancer. National Cancer Institute website. Available at: http://www.cancer.gov/cancertopics/types/cervical.

Cervical cancer. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer.

Cervical Cancer Screening: NCCC, Available at https://www.nccc-online.org/hpvcervical-cancer/cervical-cancer-screening/#.

Cervista™ HPV, Cervista™ HPV – Invader Technology. HOLOGIC website. Available at http://www.thinprep.com/hcp/cervista_hpv/what_is_cervista_hpv.html.

Cervista™ HPV 16/18, FDA Approval Letter available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080015a.pdf.

Cervista™ HPV HR Package Insert. Hologic. Available at: https://www.hologic.com/sites/default/files/package-insert/15-3053-001_106_01.pdf.

Cervista™ HPV HR and Genfind™ DNA Extraction Kit, FDA Approval Letter, available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080014a.pdf.

Check W. Data spark new directions in cervical cancer. CAP TODAY. June 2014. Available at: http://captodayonline.com/data-spark-new-directions-in-cervical-cancer/.

Check W. Study: primary HPV test 'merits consideration.' CAP TODAY. September 2014. Available at: http://captodayonline.com/study-primary-hpv-test-merits-consideration/.

Chin-Hong PV, Klausner JD. Diagnostic tests for HPV infection. Medical Laboratory Observer. October 2004:10-16.

Cobas4800HPVtestPackInsert. Scribd digital library. Available at: http://www.scribd.com/doc/84100610/cobas4800HPVtestPackInsert.

Cobas HPV Test, Roche Molecular Systems FDA application. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100020c.pdf.

Cobo F, Concha A, Ortiz M. Human papillomavirus (HPV) type distribution in females with abnormal cervical cytology. A correlation with histological study. Virology Journal. 2009;3:60-66.

Cox JT, Moriarty AT, CastlePE. Commentary on statement on HPV DNA test utilization. American Journal Clinical Pathology. 2009;131:770-773.

DeMay RM. Practical Principles of Cytopathology. Revised ed. Chicago, IL: American Society for Clinical Pathology Press; 2007.

Digene Hybrid Capture 2 High-Risk HPV DNA Test, FDA Approval Letter, available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p890064s009a.pdf.

Gardasil 9 FDA approval, available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622715.htm.

Gardasil 9 product information, FDA, available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm426445.htm.

Hariri S, Unger ER, Sternberg M, et al. Prevalence of genital human papillomavirus among females in the United States, the National Health and Nutrition Examination Survey, 2003–2006. Journal of Infectious Diseases 2011; 204(4):566–573.

HPV and cancer. National Cancer Institute Fact Sheet. Available at http://www.cancer.gov/cancertopics/factsheet/risk/hpv.

HPV and Cancer statistics, CDC, available at https://www.cdc.gov/cancer/hpv/statistics/.

HPV Vaccine Fact Sheet: National Cancer Institute, available at: https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet.

Human papillomavirus DNA detection with genotyping, high-risk types by PCR, ThinPrep. Mayo Clinic website. Available at: http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/62598.

HPV Tests: Cervical Cancer: Detection Diagnosis and Staging: American Cancer Society: Available at https://www.cancer.org/cancer/cervical-cancer/detection-diagnosis-staging/screening-tests/hpv-test.html.

HPV Test for Primary Screening: Am Sexual Health Assoc (ASHA), Available at http://www.ashasexualhealth.org/fda-approves-hpv-test-for-primary-screening/

HPV Vaccination: Committee Opinion, Clinical Guidance: ACOG, available at https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/08/human-papillomavirus-vaccination

Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices, Weekly / August 16, 2019 / 68(32);698–702. Available at https://www.cdc.gov/mmwr/volumes/68/wr/mm6832a3.htm

HPV Vaccine Fact Sheet: Recommendations: National Cancer Institute (NCI), Available at https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet

Human Papillomavirus (HPV) Vaccines. National Cancer Institute. Available at http://www.cancer.gov/cancertopics/factsheet/prevention/HPV-vaccine.

Key Statistics for Cervical Cancer: American Cancer Society: Available at https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html and https://cancerstatisticscenter.cancer.org/?_ga=2.262167304.547065751.1597685749-1295356790.1550159979#!/cancer-site/Cervix

Katki HA, Kinney WK, Fetterman B, et al. Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology: a population-based study in routine clinical practice. Lancet Oncology. 2011;12(7):663-672.

Markowitz LE, Sternberg M, Dunne EF, et al. Seroprevalence of human papillomavirus types 6, 11, 16, and 18 in the United States: national health and nutrition examination survey 2003-2004. Infectious Disease. 2009;200:1059-1067.

Molecular Diagnostics Fundamentals, Methods, and Clinical Applications. Leal Buckingham and Maribeth L. Flaws. Philadelphia: FA Davis Company; 2007.

Moyer VA, on behalf of the U.S. Preventive Services Task Force. Screening for Cervical Cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 2012; 156(12):880-91.

National Cervical Cancer Coalition, NCCC, Cervical Cancer Overview, available at https://www.nccc-online.org/hpvcervical-cancer/cervical-cancer-overview/

Open Reading Frames (ORF), SCFBIO, Tutorial, Available at http://www.scfbio-iitd.res.in/tutorial/orf.html

Open Reading Frames: National Center for Biotechnology Information, U.S. National Library of Medicine, Available at https://www.ncbi.nlm.nih.gov/mesh?Db=mesh&Cmd=DetailsSearch&Term=%22Open+Reading+Frames%22%5BMeSH+Terms%5D

Rao A, Young S, Erlich H, et al. Development and characterization of the Cobas HPV test. J Clin Microbiol. May 2013;51(5):1478-1484.

Roche receives FDA approval for Cobas HPV test for use on the Cobas 6800/8800 Systems to identify women at risk for cervical cancer: Available at https://www.roche.com/media/releases/med-cor-2020-04-21.htm

Saslow D, Solomon D, Lawson HW, et al.: American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer. J Low Genit Tract Dis 2012;16(3):175-204.

Schutzbank TE, Jarvis C, Kahmann N, et al. Detection of high-risk papillomavirus DNA with commercial invader-technology-based analyte-specific reagents following automated extraction of DNA from cervical brushings in Thinprep media. Journal of Clinical Microbiology. 2007;45:4067-4069.

Stoler MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011;135(3):468-475.

The American Congress of Obstetricians and Gynecologists. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists: Screening for Cervical Cancer. November 2012.

Updated ASCCP management guidelines. Available at: https://www.asccp.org/management-guidelines.

U.S Preventive Services Task Force: Screening for Cervical Cancer: Recommendation Statement, Am Fam Physician. 2019 Feb 15;99(4): https://www.aafp.org/afp/2019/0215/od1.html.

US Preventive Services Task Force, August 21, 2018, JAMA. 2018;320(7), available at https://jamanetwork.com/journals/jama/fullarticle/2697704.

US Cancer Statistics, CDC, available at https://gis.cdc.gov/Cancer/USCS/DataViz.html

USPSTF cervical cancer screening recommendation: Task Force Recommendation, August 21, 2018, JAMA, 2018: 320(7), available at https://jamanetwork.com/journals/jama/fullarticle/2697704.

USPSTF HPV Testing, Aug 2018, guidelines on HPV testing, available at: https://www.onclive.com/web-exclusives/uspstf-hpv-testing-alone-adequate-cervical-cancer-screening-for-some-women.

USPSTF Final Recommendation Statement: Cervical Cancer: Screening, Aug 2018, available at:https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2#consider.

Vernick JP, Steigman, CK. The HPV DNA virus hybrid capture assay: what is it—and where do we go from here? Medical Laboratory Observer. Mar 2003:8-13.

Voss JS, Kipp BR, Campion MB, et al. Comparison of fluorescence in situ hybridization, hybrid capture two and polymerase chain reaction for the detection of high-risk human papillomavirus in cervical cytology specimens. Analytical and Quantitative Cytology and Histology. 2009;31:208-216.

What are the FDA-approved indications for the human papillomavirus (HPV) DNA test? Updated: Feb 20, 2020 :Author: Peter A Gearhart, MD, Available athttps://www.medscape.com/answers/219110-56119/what-are-the-fda-approved-indications-for-the-human-papillomavirus-hpv-dna-test

What should I know about screening: Gynecologic cancers. CDC website. Available at: http://www.cdc.gov/cancer/cervical/basic_info/screening.htm.

Wright TC, Stoler MH, Behrens CM, et al. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol. 2012Jan;206(1):46.e1-46.e11.

Wright TC Jr, Stoler MH, Sharma A, et al.: Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV positive, cytology-negative results. Am J Clin Pathol. 2011 Oct;136(4):578-586.

Yousefi, Z., Aria, H., et al. "An Update on Human Papilloma Virus Vaccines: History, Types, Protection, and Efficacy." Front. Immunol, Vol 12, 26 Jan 2022. https://doi.org/10.3389/fimmu.2021.805695.