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HPV Genotypes 16 and 18

HPV Genotypes 16 and 18

Test Summary

HPV Genotypes 16 and 18


Clinical Use

  • Assess risk of cervical cancer in women 30 years of age who have a negative Pap test and a positive high-risk HPV test

  • Assess risk of cervical cancer in women who have an ASC-US cervical cytology result and a positive high-risk HPV test

Clinical Background

HPV infection causes the vast majority of all cervical cancers.1 Genital HPV types are categorized as low or high risk based on their oncogenic potential.2 Low-risk HPV types are typically associated with genital warts, whereas high-risk (HR) types are associated with invasive cervical cancer. Of the HR (oncogenic) HPV types, HPV 16 causes more than 50% of cervical cancers and HPV 18 causes 10% to 20%.3

The risk of developing cervical precancer (ie, grade 3 cervical intraepithelial neoplasia [CIN3]) or cancer is increased in women when they are infected with HPV 16 and/or 18. In a study involving more than 20,000 women whose HPV status was assessed at enrollment, the 10-year cumulative incidence of ≥CIN3 was 17% in those infected with HPV 16 and 14% in those infected with HPV 18.1 In comparison, the incidence was 3% among those positive for other HR HPV types. For patients ≥30 years old with negative cervical cytology, the cumulative incidences were 21% among those positive for type 16, 18% for type 18, and 2% for other HR HPV types.1 Based on these and other data, consensus guidelines recommend HPV 16 and 18 genotype testing for women ≥30 years old who have negative cytology and a positive HR HPV test (HR HPV testing is not recommended for women <30 with a negative Pap result).4,5

Although the consensus guidelines do not recommend HPV genotype testing for patients with atypical squamous cells of undetermined significance (ASC-US),4,5 the FDA has approved an HPV 16/18 genotyping test as an adjunct to guide management of these patients.6 Such management includes physician assessment of cervical cytology, HR HPV test results, and other risk factors.6

Individuals Suitable for Testing

  • Women ≥30 years old who have negative cervical cytology and a positive HR HPV test

  • Women who have ASC-US cervical cytology and a positive HR HPV test


  • DNA hybridization and capture using probes specific for HPV types 16 and 18

  • Signal amplification using Invader® technology

Interpretive Information

The consensus guidelines4 suggest the following actions for women 30 years and older with negative cervical cytology, positive HR HPV, and the genotype specified:

  • HPV 16 and/or 18: refer for colposcopy

  • No HPV 16 or 18: repeat both cytology and HR HPV testing in 12 months

Individuals who have ASC-US cervical cytology and HPV 16 and/or 18 have an increased risk of progression to ≥CIN2.6,7 The results of this test should not preclude women from proceeding to colposcopy.

HPV 16 and 18 genotype test results must be interpreted in conjunction with results from HR HPV testing and cervical cytology.


  1. Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97:1072-1079.

  2. Munoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348:518-527.

  3. Wheeler CM. Natural history of human papillomavirus infections, cytologic, and histologic abnormalities, and cancer. Obstet Gynecol Clin N Am. 2008;35:519-536.

  4. 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. Am J Clin Pathol. 2012;137:516-542.

  5. HPV Genotyping Clinical Update. Available at: http://www.asccp.org/consensus.shtml. Accessed January 25, 2012.

  6. Cervista® HPV 16/18 [package insert]. Madison, WI: Third Wave Technologies, Inc; 2009.

  7. Castle PE, Solomon D, Schiffman, et al. Human papillomavirus type 16 infections and 2-year absolute risk of cervical precancer in women with equivocal or mild cytologic abnormalities. J Natl Cancer Inst. 2005;97:1066-1071.

Content reviewed 12/2012
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