Statement on human papillomavirus DNA test utilization§

Authors

  • Diane Solomon MD,

    Corresponding author
    1. Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville, Maryland
    • Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Executive Plaza North, Room 2130, 6130 Executive Blvd., Rockville, MD 20852
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    • Fax: (301) 480-9939

  • Jacalyn L. Papillo CT (ASCP),

    1. Anatomic Pathology Department, Fletcher Allen Health Care, Burlington, Vermont
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  • Diane D. Davey MD

    1. Department of Medical Education, University of Central Florida, College of Medicine, Orlando, Florida
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  • This article is being published jointly in 2009 in Cancer Cytopathology (online: May 4, 2009; print: June 25), Journal of Lower Genital Tract Disease, Diagnostic Cytopathology, Acta Cytologica (print: May/June), American Journal of Clinical Pathology, and Archives of Pathology and Laboratory Medicine.

  • This is a government work and, as such, is in the public domain in the United States of America.

  • §

    In addition to the listed authors, the following individuals are also members of the Cytopathology Education and Technology Consortium and contributed to this statement: Karen Atkison, MPA, CT(ASCP), American Society of Cytopathology; Marluce Bibbo, MD, FIAC, International Academy of Cytology; George Birdsong, MD, American Society of Cytology; Tom Bonfiglio, MD; American Society for Clinical Pathology; Lydia Howell, MD, Papanicolaou Society of Cytopathology; Elizabeth Jenkins, MS, American Society of Cytopathology, administrative support; Lynnette Savaloja, SCT(ASCP), American Society for Cytotechnology; and David Wilbur, MD, College of American Pathologists.

  • See also pages 149–50.

Abstract

This statement summarizes the expanded role of human papillomavirus (HPV) testing in the screening and management of cervical cancer. It also highlights circumstances in which HPV testing is not appropriate and may lead to overtreatment.

Testing for carcinogenic or high‒risk human papillomavirus (HPV) DNA has proven usefulness in cervical cancer screening and in many aspects of the clinical management of cervical cancer prevention. However, inappropriate testing increases costs without benefit and potentially results in the overtreatment of women. This statement was developed by the Cytopathology Education and Technology Consortium (CETC) and has been endorsed by additional professional medical societies. It is intended as a concise, convenient summary of clinical indications for HPV DNA test utilization based on the 2002 American Cancer Society screening recommendations1 and interim guidance,2 and the 2006 American Society for Colposcopy and Cervical Pathology (ASCCP) consensus management guidelines.3, 4 Circumstances in which HPV DNA testing is considered appropriate and those in which such testing is generally not appropriate are outlined below. This statement and Figure 1 are intended to serve as educational tools and references with which to improve the management of women and reduce the inappropriate use of HPV tests.

Figure 1.

Appropriate uses of human papillomavirus (HPV) testing in screening and triage. ASC‒US indicates atypical squamous cells of undetermined significance; LSIL, low‒grade squamous intraepithelial lesion; ASC‒H, atypical squamous cells, cannot exclude high‒grade squamous intraepithelial lesion; AGC, atypical glandular cells; HSIL, high‒grade squamous intraepithelial lesion.

  • 1High‒risk (oncogenic) HPV DNA testing is appropriate in the following circumstances:
    • 1.1Routine cervical cancer screening in conjunction with cervical cytology (dual testing or co‒testing) for women aged ≥30 years:
      • 1.1.1For women who are cytology negative but HPV positive, repeat both tests in 12 months (As of March 2009, the US Food and Drug Administration approved an HPV type 16/18 genotyping test; as per ASCCP guidelines,3, 4 HPV 16/18-positive women aged ≥30 years are referred directly for colposcopy.)
      • 1.1.2For women who are both cytology and HPV negative, repeat both tests only after a 3‒year interval.
    • 1.2Initial triage management of women aged ≥21 years with a cytologic result of atypical squamous cells of undetermined significance (ASC‒US).
    • 1.3Initial triage management of postmenopausal women with a cytologic result of low‒grade squamous intraepithelial lesion (LSIL).
    • 1.4Postcolposcopy management of women of any age with an initial cytologic result of atypical glandular cells (AGC)* or atypical squamous cells, cannot exclude high‒grade squamous intraepithelial lesion (ASC‒H) (when the initial workup does not identify a high‒grade lesion).
    • 1.5Postcolposcopy management of women aged ≥21 years with initial cytologic results of ASC‒US or LSIL (when the initial colposcopy does not identify a high‒grade lesion).
    • 1.6Post‒treatment surveillance.
  • 2High‒risk (oncogenic) HPV DNA testing is generally not appropriate in the following situations:
    • 2.1Routine cervical cancer screening in women aged <30 years.
    • 2.2Routine screening with HPV testing and cervical cytology more often than every 3 years for women aged ≥30 years whose tests were negative at the time of last screening (see 1.1.2 above).
    • 2.3Initial triage or management of adolescents (aged ≤ 20 years) with any abnormal cytologic result. Furthermore, if HPV testing is inadvertently performed, the results should not be used to influence patient management.
    • 2.4Initial triage of LSIL (except for postmenopausal women; see 1.3 above).
    • 2.5Initial triage of ASC-H, high‒grade squamous intraepithelial lesion (HSIL), or AGC*/adenocarcinoma in situ (AIS) in women of any age.
  • 3Repeat high‒risk (oncogenic) HPV DNA testing should generally not be performed within <12 months:
    • 3.1Exceptions include as a follow‒up to AGC, not otherwise specified (AGC NOS) when no pathology is found at the time of the initial workup and as follow‒up after treatment for cervical intraepithelial neoplasia grades 2 and 3 (CIN 2,3). See the ASCCP guidelines for specific recommendations concerning testing intervals.3, 4
  • 4Testing for low‒risk (nononcogenic) HPV types has no role in routine cervical cancer screening or for the evaluation of women with abnormal cervical cytology.

Endorsed by the

American Cancer Society

American Society for Clinical Pathology#

ASCCP

American Society of Cytopathology#

American Society for Cytotechnology#

College of American Pathologists#

International Academy of Cytology#

Papanicolaou Society of Cytopathology#

#Indicates a member of the CETC.

The intent of this summary is to facilitate provider education and to encourage the appropriate utilization of HPV testing. Clinical judgment should always be used when applying a guideline to an individual patient because it is impossible to develop guidelines that will apply to all situations. Links to the 2006 ASCCP Consensus Guidelines, as well as management algorithms, are available on the ASCCP website at http://www.asccp. org/consensus/cytological.shtml accessed on April 22, 2009.

  • 1

    Note that for a finding of AGC, HPV testing is not to be used for triage to decide whether to refer for colposcopy; however, HPV testing may be performed at the time of colposcopy to guide postcolposcopy management.

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