Statement on Human Papillomavirus
DNA Test Utilization*,†
Diane Solomon, MD1; Jacalyn L. Papillo, CT (ASCP)2; and Diane D. Davey, MD3, for the Cytopathology
Education and Technology Consortium (CETC)
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 overtreat-
ment of women. This statement was developed by the Cytopathology Education and Technology Con-
sortium (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 recommendations1and interim guidance,2and 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.
1. High-risk (oncogenic) HPV DNA testing is appropriate in the following circumstances:
1.1. Routine cervical cancer screening in conjunction with cervical cytology (dual testing or co-test-
ing) for women aged ?30 years:
1.1.1. For 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,3,4HPV 16/18-positive women aged ?30
years are referred directly for colposcopy.)
Received: March 30, 2009; Accepted: April 8, 2009
Published online: May 4, 2009, Published 2009 by the American Cancer Society
DOI: 10.1002/cncy.20031, www.interscience.wiley.com
Corresponding author: Diane Solomon, MD, 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; Fax: (301) 480-9939; email@example.com
1Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville,
Maryland;2Anatomic Pathology Department, Fletcher Allen Health Care, Burlington, Vermont;3Department of Medical Education, University of Cen-
tral Florida, College of Medicine, Orlando, Florida
*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
†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 con-
tributed 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, Papa-
nicolaou 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 editorial on pages 149–50.
June 25, 2009
1.1.2. For women who are both cytology
and HPV negative, repeat both tests
only after a 3-year interval.
1.2. Initial triage management of women aged
?21 years with a cytologic result of atypical
squamous cells of undetermined significance
1.3. Initial triage management of postmenopausal
women with a cytologic result of low-grade
squamous intraepithelial lesion (LSIL).
1.4. Postcolposcopy 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).
aged ?21 years with initial cytologic results
of ASC-US or LSIL (when the initial colpo-
scopy does not identify a high-grade lesion).
1.6. Post-treatment surveillance.
*Note that for a finding of AGC, HPV testing is not
to be used for triage to decide whether to refer for colpo-
scopy; however, HPV testing may be performed at the time
of colposcopy to guide postcolposcopy management.
2. High-risk (oncogenic) HPV DNA testing is
generally not appropriate in the following
2.1. Routine cervical cancer screening in women
aged <30 years.
2.2. Routine screening with HPV testing and cervical
cytology more often than every 3 years for
atthetimeof lastscreening (see1.1.2above).
2.3. Initial triage or management of adolescents
(aged ? 20 years) with any abnormal cytologic
result. Furthermore, if HPV testing is inadver-
tently performed, the results should not be
used to influence patient management.
2.4. Initial triage of LSIL (except for postmeno-
pausal women; see 1.3 above).
2.5. Initial triage of ASC-H, high-grade squa-
AGC*/adenocarcinoma in situ (AIS) in
women of any age.
3. Repeat high-risk (oncogenic) HPV DNA test-
ing should generally not be performed within
3.1. Exceptions include as a follow-up to AGC, not
otherwise specified (AGC NOS) when no pa-
and as follow-up after treatment for cervical
intraepithelial neoplasia grades 2 and 3 (CIN
2,3). See the ASCCP guidelines for specific rec-
ommendations concerning testing intervals.3,4
4. Testing for low-risk (nononcogenic) HPV
types has no role in routine cervical cancer
screening or for the evaluation of women
with abnormal cervical cytology.
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 squa-
mous intraepithelial lesion.
HPV DNA Testing/Solomon et al
June 25, 2009
The intent of this summary is to facilitate provider Download full-text
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 Consen-
sus Guidelines, as well as management algorithms, are
available on the ASCCP website at http://www.asccp.
org/consensus/cytological.shtml accessed on April 22,
1. Saslow D, Runowicz CD, Solomon D, et al; American
Cancer Society. American Cancer Society guideline for the
early detection of cervical neoplasia and cancer. CA Cancer
J Clin. 2002;52:342-362.
2. Wright TC Jr, Schiffman M, Solomon D, et al. Interim
guidance for the use of human papillomavirus DNA testing
as an adjunct to cervical cytology for screening. Obstet
3. Wright TC Jr, Massad LS, Dunton CJ, Spitzer M, Wilkin-
son EJ, Solomon D; 2006 ASCCP-Sponsored Consensus
Conference. 2006 consensus guidelines for the management
of women with abnormal cervical screening tests. J Low
Genit Tract Dis. 2007;11:201-222.
4.Wright TC Jr, Massad LS, Dunton CJ, Spitzer M, Wilkin-
son EJ, Solomon D;2006 American Society for Colposcopy
and Cervical Pathology-sponsored Consensus Conference.
2006 consensus guidelines for the management of women
with abnormal cervical cancer screening tests. Am J Obstet
June 25, 2009