Statement on human papillomavirus DNA test utilization.
Subject: DNA testing (Methods)
DNA testing (Standards)
Papillomavirus infections (Diagnosis)
Medical care (Utilization)
Medical care (Analysis)
Cancer (Diagnosis)
Cancer (Methods)
Cancer (Standards)
Authors: Solomon, Diane
Papillo, Jacalyn L.
Davey, Diane D.
Pub Date: 08/01/2009
Publication: Name: Archives of Pathology & Laboratory Medicine Publisher: College of American Pathologists Audience: Academic; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2009 College of American Pathologists ISSN: 1543-2165
Issue: Date: August, 2009 Source Volume: 133 Source Issue: 8
Topic: Event Code: 350 Product standards, safety, & recalls
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 230247117
Full Text: Testing for carcinogenic or high-risk human papillomavirus (HPV) DNA has proven utility in cervical cancer screening and in many aspects of clinical management for cervical cancer prevention. However, inappropriate testing increases costs without benefit and potentially results in overtreatment of women. This Statement was developed by The Cytopathology Education and Technology Consortium and has been endorsed by additional professional medical societies as listed below. It is intended as a concise, convenient summary of clinical indications for HPV DNA test utilization based on the American Cancer Society 2002 screening recommendations (1) and interim guidance, (2) and the 2006 American Society for Colposcopy and Cervical Pathology (ASCCP) consensus management guidelines. (3) Circumstances in which HPV DNA testing is considered appropriate, and when such testing is generally not appropriate, are outlined below. This statement and Figure are intended as educational tools and references to improve management of women and reduce 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 cotesting) for women 30 years and older

1.1.1. For women whose cytology results are negative but are HPV positive, repeat both tests in 12 months (As of March 2009, the US Food and Drug Administration approved a HPV 16/18 genotyping test;per ASCCP guidelines, (3) HPV 16- and/or HPV 18-positive women, 30 years and older, are referred directly to colposcopy.)

1.1.2. For women whose cytology and HPV results are both negative, repeat both tests only after a 3-year interval

1.2. Initial triage management of women 21 years and older with a cytologic result of atypical squamous cells of undetermined significance (ASC-US)

1.3. Initial triage management of postmenopausal women with cytologic result of low-grade squamous intraepithelial lesion (LSIL)

1.4. Postcolposcopy management of women of any age with initial cytologic result of atypical glandular cells ([dagger]) (AGCs) or atypical squamous cells, cannot exclude a high-grade squamous intraepithelial lesion (ASC-H) (when initial workup does not identify a high-grade lesion)

1.5. Postcolposcopy management of women 21 years and older with initial cytologic results of ASC-US or LSIL (when initial colposcopy does not identify a high-grade lesion)

1.6. Posttreatment surveillance

2. High-risk (oncogenic) HPV DNA testing is generally not appropriate in the following situations;

2.1. Routine cervical cancer screening in women younger than 30 years

2.2. Routine screening with HPV testing and cervical cytology more often than every 3 years for women 30 years and older whose tests were negative at last screening (see 1.1.2. above)

2.3. Initial triage or management of adolescents/young adults (age 20 years and younger) with any abnormal cytologic result; further, if HPV testing is inadvertently performed, the results should not be used to influence patient management

2.4. Initial triage of LSIL (except for postmenopausal women; see 1.3 above)

2.5. Initial triage of ASC-H, high-grade squamous intraepithelial lesion (HSIL), or AGC ([dagger])/adenocarcinoma in situ (AIS) in women of any age

3. Repeat high-risk (oncogenic) HPV DNA testing should generally not be done before 12 months.

3.1. Exceptions include follow-up to atypical glandular cells-not otherwise specified (AGC NOS) when no pathology is found at initial workup and follow-up after treatment for cervical intraepithelial neoplasia (CIN) 2,3; see ASCCP guidelines for specific recommendations on testing intervals (3)

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.

Endorsed by the following organizations:

([double dagger]) American Cancer Society

([double dagger]) American Society for Clinical Pathology

([double dagger]) American Society for Colposcopy and Cervical Pathology

([double dagger]) American Society of Cytopathology

([double dagger]) American Society for Cytotechnology

([double dagger]) College of American Pathologists

([double dagger]) International Academy of Cytology

([double dagger]) Papanicolaou Society of Cytopathology

([double dagger]) Members of the Cytopathology Education and Technology Consortium.

The intent of this summary is to facilitate provider education and to encourage appropriate utilization of HPV testing. Note: Clinical judgment should always be used when applying a guideline to an individual patient because it is impossible to develop guidelines that 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.

References

(1.) Saslow D, Runowicz CD, Solomon D, et al. American Cancer Society guideline for early detection of cervical neoplasia and cancer. CA Cancer J Clin. 2002; 52(6):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 Gynecol. 2004;103(2):304-309.

(3.) Wright TC, Massad LS, Dunton CJ, Spitzer M, Wilkinson EJ, Solomon D. for the 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 Gynecol. 2007; 197(4);346-355.

([dagger]) Note that for AGC results, HPV testing is not to be used for triage to decide whether to refer to colposcopy; however, HPV testing may be done at the time of colposcopy to guide postcolposcopy management.

Diane Solomon, MD; Jacalyn L. Papillo, CT(ASCP); Diane D. Davey, MD; for the Members of the Cytopathology Education and Technology Consortium

Accepted for publication April 16, 2009.

From the Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville, Maryland (Dr Solomon); Anatomic Pathology Department, Fletcher Allen Health Care, Burlington,Vermont(MsPapillo);and the College of Medicine, University of Central Florida, Orlando (Dr Davey).

The Archives is aware that this manuscript has been submitted to several other journals for publication, in the interest of widespread dissemination.

Reprints are not available from the author.

Corresponding author: Diane Solomon, MD, Department of Health and Human Services, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, 6130 Executive Blvd, Rockville, MD 20852 (e-mail: ds87v@nih.gov).
Initial Trial
Age                           Routine
                             Screening   ASC-US   LSIL   ASC-H

[less than or equal to] 20    2 1         2.3     2.3     2.3
21-29                         2.1         1.2     2.4     2.5
[less than or equal to] 30    1.1 *       1.2     2.4     2.5
Postmenopausal                1.1 (#)     1.2     1.3     2.5

                             Initial Trial
Age
                             AGC *   HSIL
[less than or equal to] 20    2.3    2.3
21-29                         2.5    2.5
[less than or equal to] 30    2.5    2.5
Postmenopausal                2.5    2.5

Appropriate uses of human papillomavirus (HPV) testing in screening
and triage. Cell color indicates if HPV testing is appropriate (green)
or not appropriate (red). Numbers in table cells refer to text outline.
Abbreviations: AGC, atypical glandular cells; ASC-H, atypical squamous
cells, cannot exclude a high-grade squamous intraepithelial lesion;
ASC-US, atypical squamous cells of undetermined significance; HSIL,
high-grade squamous intraepithelial lesion; LSIL, low-grade squamous
intraepithelial lesion.

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

(#) For women 30 years and older who are both cytology and HPV
negative, repeat both tests only after a 3-year interval.
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