To the Editor:
Recently, the Enduring Consensus Cervical Cancer Screening and Management Guidelines (Enduring Guidelines) committee developed and published recommendations for the management of HPV test results from vaginal specimens self-collected in health care settings.1 It established that HPV vaginal self-collection is an acceptable alternative to clinician-collection that expands screening and management when provider collection is not an option.1
The clinical performance of HPV self-collection is related to several factors, including the sampling device, the transport medium (liquid versus dry), and the HPV assay, all of which are part of the regulatory evaluation. Previous recommendations applied to self-collected vaginal specimens using the Roche cobas (with either the Copan FLOQSwab or the Evalyn brush) and BD Onclarity (with the Copan FLOQSwab) assays in clinical settings. Since then, a new sampling device, the Teal Wand, in combination with the Roche cobas HPV test, received FDA approval for at-home HPV self-collection.2 More recently, the Abbott Alinity m assay received regulatory approval for clinic-based self-collection (with either the Qvintip or the Evalyn brush).
The Enduring Guidelines committee evaluated the data supporting regulatory approval of the home-based self-collection approach and used the standard process for evidence review and voted to expand the existing recommendations for HPV self-collection.1,3,4 Among assays with approval for self-collection of vaginal HPV specimens, the ability to collect the sample at home instead of in a clinical setting is primarily a question of sample stability in dry storage and subsequent extraction of adequate material for testing. HPV test results are comparable between different sampling devices and storage options; therefore, management should not differ based on the location of specimen collection.
The Teal Wand at-home collection kit received regulatory approval “as a device to be used for the collection and transport of vaginal specimens for use with an FDA-approved molecular assay on which the device has been validated.”2 The approval was based on the Self-CERV trial, in which samples were collected with the Teal Wand, transported to the laboratory in dry conditions, and tested with the Roche cobas assay.4 The positive percentage agreement (PPA) between clinician-collected cervical specimens and self-collected vaginal specimens using the Teal Wand with the Roche cobas assay was high, showing 95% PPA for any high-risk HPV, 96% PPA for HPV16 or HPV18, and 94% PPA for the other 12 HPV types (HR 12); the negative percentage agreement was 90% for any high-risk HPV. While the study was not powered for CIN3+ detection, 28 of 29 (97%) CIN3 were HPV-positive with self-collected specimens using the Teal Wand.
The Enduring Guidelines committee evaluated whether Roche cobas test results obtained using the Teal Wand can be managed using the existing self-collection guidelines. The evidence presented for Teal Wand, demonstrating high positive agreement for HPV detection (overall and by type channel) in a cross-sectional setting, fulfilled the same endpoints as those used in prior recommendations for self-collected vaginal specimens.1 Similar to data evaluated for previous recommendations, the Self-CERV study was not powered for precancer endpoints and did not include long-term prospective data. Based on the available data, the Enduring Guidelines committee concluded that the existing guidelines could be applied to specimens collected using the Teal Wand with the Roche cobas assay. The recommendation was approved by representatives from 19 national organizations, per usual voting protocols.3
Recommendation:
The Enduring Guidelines recommendations for the management of self-collected vaginal HPV specimens1 apply to specimens acquired using an FDA-approved combination of sampling device and HPV assay for home collection.
At the time of this update, recommendations for self-collected vaginal HPV specimens apply to the following FDA-approved combinations:
| HPV test | Device | Setting |
| Roche cobas | Teal Wand | Home |
| Roche cobas | Copan 552C FLOQSwab | Clinic |
| Roche cobas | Evalyn Brush | Clinic |
| BD Onclarity | Copan 5C188S FLOQSwab | Clinic |
| Abbott Alinity m | Evalyn Brush | Clinic |
| Abbott Alinity m | Qvintip swab (part of simpli-COLLECT kit) | Clinic |
Specifically, the previously published recommendations relevant to the Teal Wand at-home collection kit in combination with the Roche cobas assay are: (1) clinician-collected cervical specimens are preferred, and self-collected vaginal specimens are acceptable for screening; (2) when a self-collected vaginal HPV test result is negative in the screening setting, repeat testing is recommended in 3 years; (3) direct colposcopy referral is recommended for HPV 16 or HPV 18 positive results, and cytology collection is recommended at the time of colposcopy; (4) collection of a cervical specimen for cytology or p16/Ki67 dual stain testing is recommended when test results are positive for other high-risk HPV types to determine the need for colposcopy; (5) clinician-collected specimens are preferred for patients under surveillance for prior abnormal results, but self-collection is acceptable after shared decision-making.
Considerations:
This recommendation applies only to FDA-approved device and test combinations. Test accuracy may depend on assay type, transport medium, sample dilution, and collection device, among other factors.5 Lab-developed tests or tests marketed directly to consumers that have not undergone rigorous evaluation may not achieve the required sensitivity or specificity.
Home tests must be handled according to instructions, with attention paid to expiration dates, time between sample collection and mailing, and time between mail date and receipt to ensure that accuracy in real-life practice is comparable with clinical trials.
Primary HPV screening, and by extension self-collection, is currently not approved for use in patients who are HIV-positive or immunosuppressed, DES-exposed in utero, pregnant, currently menstruating, currently experiencing abnormal bleeding, or under age 25 years.1,2
Before initiating self-collection in clinical practice, having a process in place for navigating and triaging abnormal screening results is critical to avoid loss to follow-up.
The Enduring Guidelines committee will continue to review new data/assays/devices receiving regulatory approval for use with self-collected vaginal specimens in either the clinic or home setting, with the goal of providing rapid updates. Of note, the Self-collection for HPV testing to Improve Cervical Cancer Prevention (SHIP) trial (Last Mile effort) is underway to evaluate HPV tests with current approval for primary screening in the clinic setting for additional use in home collection.6
Acknowledgments
Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee Group Author List
Randall L. Ball, MD, Phoenix VA Health Care System/University of Arizona College of Medicine-Phoenix, Arizona.
Lynn Barclay, American Sexual Health Association, Research Triangle Park, NC.
Debbie Barish, Nurses for Sexual and Reproductive Health, St Paul, MN.
David Chelmow, MD, Virginia Commonwealth University School of Medicine, Richmond, VA.
Li C. Cheung, PhD, National Cancer Institute, Rockville, MD.
David Chhieng, MD, MBA, Papanicolau Society of Cytopathology, Philadelphia, PA.
Kim Choma, DNP, APN, WHNP-E, Mountainside, NJ.
Michelle Collins, PhD, CNM, American College of Nurse-Midwives, Silver Spring, MD.
Teresa M. Darragh, MD, University of California San Francisco, San Francisco, CA.
Diane D. Davey, MD, University of Central Florida, Orlando, FL.
Megan Eagen-Torkko, PhD, CNM, ARNP, School of Nursing, Wayne State University, Detroit, MI.
Mark H. Einstein, MD, MS, Department of OB/GYN & Women’s Health, Montefiore Medical School, New York, NY.
Carol C. Eisenhut, MD, MBA, DCL Pathology, Indianapolis, IN.
Didem Egemen, PhD, National Cancer Institute, Rockville, MD.
Robert A. Goulart, Department of Pathology, UMass Chan Medical School, UMass Memorial Medical Center, Worcester, MA.
Abha Goyal, MD, Weill Cornell Medicine-New York Presbyterian Hospital, New York, NY.
June S. Gupta, CRNP, Planned Parenthood Federation of America, New York, NY.
Eric C. Huang, MD, PhD, University of Washington School of Medicine/Harborview Medical Center, Seattle, WA.
Warner Huh, MD, University of Alabama, Birmingham, AL.
Alexander Locke, MD, Associate Professor, California Northstate University School of Medicine, Elk Grove, CA.
Thomas Lorey, MD, Kaiser Permanente Northern California, Berkeley, CA (retired).
Melanie Lucks, MMS, PA-C, Association for Physician Associates in Obstetrics and Gynecology, Kimberly, WI.
Anna-Barbara Moscicki, MD, Department of Pediatrics, University of California Los Angeles, Los Angeles, CA.
Morgan Newman, MSW, Cervivor Inc.
Elizabeth W. Patton, MD, MPhil, MSc, Boston University School of Medicine/Boston Medical Center, VA Boston Healthcare System, Boston, MA.
Melissa Rodriguez, DMSc, PA-C, Association of Physician Associates in Obstetrics and Gynecology (APAOG), Kimberly, WI.
George F. Sawaya, MD, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA.
Sana O. Tabbara, MD, Moffitt Cancer Center, Tampa, FL.
Deanna Teoh, MD, University of Minnesota, Minneapolis, MN.
Kelly Welch, Team Maureen, North Falmouth, MA.
Fred Wyand, American Sexual Health Association, Research Triangle Park, NC.
Footnotes
Disclaimer: The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, the National Cancer Institute, or the American Cancer Society. D.C. is a member of the United States Preventive Services Task Force (USPSTF); this article does not necessarily represent the views and policies of the USPSTF. D.C. has recused himself from the development of recommendations related to screening and fully participated in recommendations related to diagnosis and management. R.S. leads guideline development at the American Cancer Society, but decisions about ACS cancer screening guidelines are made by an independent ACS Guideline Development Group; thus, this article does not necessarily represent the views of the American Cancer Society related to screening. R.S. has recused himself from the development of recommendations related to screening and fully participated in recommendations related to diagnosis and management.
The authors have declared they have no conflicts of interest.
Contributor Information
Nicolas Wentzensen, Email: wentzenn@mail.nih.gov.
L. Stewart Massad, Email: massadl@wustl.edu.
Megan A. Clarke, Email: megan.clarke@nih.gov.
Francisco Garcia, Email: franciscogarcia@arizona.edu.
Robert Smith, Email: robert.smith@cancer.org.
Jeanne Murphy, Email: jmurph60@jh.edu.
Richard Guido, Email: guidrs@upmc.edu.
Ana Reyes, Email: ana@reyes.net.
Sarah Phillips, Email: sarah.phillips.598@gmail.com.
Nancy Berman, Email: nrberman@comcast.net.
Jeffrey Quinlan, Email: Jeffrey-Quinlan@uiowa.edu.
Eileen Lind, Email: eileen@teammaureen.org.
Ritu Nayar, Email: r-nayar@northwestern.edu.
Rebecca B. Perkins, Email: rebecca.perkins1@tuftsmedicine.org.
Collaborators: Randall L. Ball, Lynn Barclay, Debbie Barish, David Chelmow, Li C. Cheung, David Chhieng, Kim Choma, Michelle Collins, Teresa M. Darragh, Diane D. Davey, Megan Eagen-Torkko, Mark H. Einstein, Carol C. Eisenhut, Didem Egemen, Robert A. Goulart, Abha Goyal, June S. Gupta, Eric C. Huang, Warner Huh, Alexander Locke, Thomas Lorey, Melanie Lucks, Anna-Barbara Moscicki, Morgan Newman, Elizabeth W. Patton, Melissa Rodriguez, George F. Sawaya, Sana O. Tabbara, Deanna Teoh, Kelly Welch, and Fred Wyand
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