Self-Collected Vaginal Specimens for HPV Testing: Recommendations From the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee

Abstract

Objective: The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of self-collected vaginal specimens for human papillomavirus (HPV) testing in health care settings.

Methods: A comprehensive literature search was performed, external systematic reviews were evaluated, and HPV genotype agreement between self-collected vaginal and clinician-collected cervical specimens was summarized. Recommendations considered available data, public comments, and expert consensus. Recommendations were ratified through a vote by the Consensus Stakeholder Group.

Results: Clinician-collected cervical specimens are preferred and self-collected vaginal specimens are acceptable for primary HPV screening of asymptomatic average-risk individuals. Repeat testing in 3 years is recommended following HPV-negative screens using self-collected vaginal specimens. Colposcopy with collection of cytology and biopsies is recommended following positive tests for HPV types 16 and 18. Clinician-collected cytology or dual stain for triage testing is recommended following positive tests for HPV 45, 33/58, 31, 52, 35/39/68, or 51 or for pooled HPV other types but negative for HPV 16 or 18. Repeat HPV testing in 1 year is recommended following a positive test for HPV types 56/59/66 and no other carcinogenic types. Minimal data exist on use of self-collected vaginal specimens for surveillance following abnormal screening test results, colposcopy or treatment, and therefore, clinician-collected cervical specimens are preferred.

Conclusions: Human papillomavirus testing of self-collected vaginal specimens expands cervical cancer screening options and has potential to increase access for currently underscreened individuals. Laboratory and clinical workflows will need to be modified to ensure adequate specimen processing and follow-up.

FIGURE 1

Summary of management for positive HPV screening test results with self-collected and clinician-collected specimens for settings using cytology (either as a cotest or triage test). Abbreviations: AGC indicates atypical glandular cells; ASC-H, atypical squamous cells, cannot exclude HSIL; ASC-US, atypical squamous cells of undetermined significance; CIN, cervical intrepithelial neoplasia;HPV, human papillomavirus; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion or malignancy; Note: For patients with a history of high-grade histology, high-grade cytology (HSIL or persistent ASC-H) or following treatment (or observation of CIN2), 2019 guidelines should be followed.

FIGURE 2

Summary of management for positive HPV screening results with self-collected and clinician-collected specimens for settings using reflex testing with p16^ink4a/Ki-67 dual stain. Abbreviations: CIN indicates cervical intraepithelial neoplasia; HPV, human papillomavirus; <CIN2, CIN1 or less; CIN2+, CIN2, CIN3, adenocarcinoma in situ, cancer; NILM, negative for intraepithelial lesion or malignancyIf cytology is performed in a cotesting setting and a dual-stain result is negative, repeat HPV testing in 1 year is recommended for NILM, ASC-US, or LSIL results. Colposcopy is recommended for ASC-H, AGC, or HSIL cytology results. Normal screening history documented in medical record, and/or patient is in the general screening population and has no known history of CIN2+ If cytology is performed in a cotesting setting, colposcopy is recommended for all results including NILM Note: For patients with a history of high-grade histology, high-grade cytology (HSIL or persistent ASC-H), following surveillance of CIN2 or treatment of CIN2+, 2019 guidelines should be followed.