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papillomavirus (HPV) DNA; high-risk HPV testing

Indications: - diagnosis of papillomavirus infection - recommended as adjunctive testing to cervical cytology in women > 30 years of age (see recommendations for performing Pap smears) [2] - standalone cervical cancer screening test* - FDA-approval April 2014 [5] - cervical cancer screening for high-risk women >= 25 years of age [7] - repeat screening at intervals of 3 years or longer - HPV testing associated with a lower likelihood of high-grade cervical lesions after 4 years compared with Pap smear [8] Specimen: - cervical smears - self-collected vaginal swabs for high-risk women [9] - biopsies or scrapings - anogenital tissue - urine [6] - store tissue at -20 degrees C or below Management: - women who screen positive for HPV 16 or 18 should undergo colposcopy - women who screen positive for HPV 12 other high-risk types should undergo cytology & then either colposcopy or follow-up in 12 months [7] Notes: - over 50 recognized types - better sensivitity (94.6% vs 55.4%) but poorer specificity (94.1% vs 96.8%) for high-grade cervical intraepithelial neoplasia than Pap smear [3] - several different tests [3,4] * also see ARUP consult [10]

Related

Papanicolaou (Pap) smear papillomavirus PCR/southern blot/in-situ hybridization for cervical cancer

Specific

human papilloma virus 16+18 DNA in tissue human papilloma virus genotyping papilloma virus 16 DNA papilloma virus 18 DNA anorectal papilloma virus 18 DNA in cervix

General

papilloma virus (HPV) nucleic acid

References

  1. Clinical Guide to Laboratory Tests, 3rd ed. Teitz ed., W.B. Saunders, 1995
  2. Journal Watch 24(6):452, 2004 Wright TC Jr et al, Obstet Gynecol 103:304, 2004 PMID: 14754700
  3. Mayrand M-H et al, Human papilloma DNA versus Papanicolau screening tests for cervical cancer. N Engl J Med 2007, 357:1579 PMID: 17942871
  4. FDA Approves Roche's HPV Test for Identifying Women at Highest Risk for Cervical Cancer, April 20, 2011 http://www.roche.com/media/media_releases/med-cor-2011-04-20.htm
  5. Herman AO NEJM Journal Watch. March 14, 2014 Massachusetts Medical Society http://www.jwatch.org - FDA News Release: April 24, 2014 FDA approves first human papillomavirus test for primary cervical cancer screening. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394773.htm
  6. Pathak N et al Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis. BMJ 2014;349:g5264 PMID: 25232064 http://www.bmj.com/content/349/bmj.g5264
  7. Young K, Sadoughi S, Sofair A Interim Guidance Released on Primary High-Risk HPV Testing for Cervical Cancer. Physician's First Watch, Jan 12, 2015 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org Huh WK, Ault KA, Chelmow D et el Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance. Gynecologic Oncology. Jan 7, 2015 PMID: 25569009 http://www.gynecologiconcology-online.net/article/S0090-8258%2814%2901577-7/fulltext
  8. Ogilvie SG, van Niekerk D, Krajden M et al Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months. The HPV FOCAL Randomized Clinical Trial. JAMA. 2018;320(1):43-52 PMID: 29971397 https://jamanetwork.com/journals/jama/fullarticle/2686793 - Massad LS Replacing the Pap Test With Screening Based on Human Papillomavirus Assays. JAMA. 2018;320(1):35-37 PMID: 29971379 https://jamanetwork.com/journals/jama/fullarticle/2686771
  9. Arbyn M, Smith SB, Temin S et al Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. BMJ 2018;363:k4823 PMID: 30518635 https://www.bmj.com/content/363/bmj.k4823
  10. ARUP Consult: Human Papillomavirus (HPV) Testing - Cervical Cancer Screening The Physician's Guide to Laboratory Test Selection & Interpretation https://www.arupconsult.com/content/human-papillomavirus