GUIDELINE, ALGORITHM, DECISION AID
GUIDELINE, ALGORITHM, DECISION AID
Self-Collected Vaginal Specimens for HPV Testing: Recommendations From the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee
Objective: The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of self-collected vaginal specimens for human papillomavirus testing in health care settings.
Methods: A comprehensive literature search was performed, external systematic reviews were evaluated, and human papillomavirus 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 human papillomavirus screening of asymptomatic average-risk individuals. Repeat testing in three years is recommended following human papillomavirus-negative screens using self-collected vaginal specimens. Colposcopy with collection of cytology and biopsies is recommended following positive tests for human papillomavirus types sixteen and eighteen. Clinician-collected cytology or dual stain for triage testing is recommended following positive tests for human papillomavirus forty-five, thirty-three/fifty-eight, thirty-one, fifty-two, thirty-five/thirty-nine/sixty-eight, or fifty-one or for pooled human papillomavirus other types but negative for human papillomavirus sixteen or eighteen. Repeat human papillomavirus testing in one year is recommended following a positive test for human papillomavirus types fifty-six/fifty-nine/sixty-six 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.
Cervical cancer screening reduces cervical cancer incidence and mortality. Cervical cytology, the first cervical screening test, is subjective and has a relatively low sensitivity, requiring frequent repeat testing to identify precancers that can be treated to prevent cancer. The discovery that persistent human papillomavirus infections are a necessary cause of almost all cervical cancers led to the development of human papillomavirus testing as a new primary screening method. Human papillomavirus testing, an objective test with higher sensitivity and better reassurance against cancer after a negative test compared to cytology, is now the preferred screening strategy in guidelines worldwide.
Human papillomavirus testing can also be performed using self-collected vaginal specimens, extending the reach of cervical screening to sites with limited clinician access and to individuals who prefer self-collection over clinician collection for various reasons. Human papillomavirus testing of self-collected vaginal specimens has been widely evaluated and shown to perform similarly when compared to clinician-collected cervical specimens. Several large screening programs have added self-collection to the screening options, including national programs in Australia and the Netherlands, which has increased screening participation.
Recently, the US Food and Drug Administration extended the indications for two human papillomavirus tests previously approved for primary human papillomavirus screening (cobas and Onclarity) to include self-collected vaginal specimens in health care settings where specimens can be processed by trained personnel and transported to a testing laboratory under controlled conditions. Clinical guidance is needed for use of human papillomavirus self-collection in the United States.
The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee was established as a standing committee with representatives from nineteen national organizations to evaluate new technologies for cervical screening and management that have received regulatory approval for clinical use and to provide recommendations for use of these new technologies. This manuscript summarizes the US recommendations for use of human papillomavirus testing using self-collected vaginal specimens with FDA-approved testing options in cervical screening and management.
METHODS
METHODS
The guiding principles and approach of the Enduring Guidelines development process have been described. The first step of the evidence assessment is defining Population, Intervention, Comparator, and Outcomes for specific questions. Next, a systematic evaluation is conducted to determine the availability of primary data or existing systematic reviews and meta-analyses addressing the Population, Intervention, Comparator, and Outcomes questions. A de novo systematic review is performed if neither source of evidence is available. The Enduring Guidelines Risk Assessment Group adopted the following Populations, Interventions, Comparators, and Outcomes used in previous systematic reviews on human papillomavirus self-collection: Population: persons with a cervix presenting to a clinic for cervical cancer screening or follow-up. Index test: human papillomavirus testing on self-collected vaginal specimens. Comparator tests: human papillomavirus testing on clinician-collected cervical specimens; cervical cytology where available. Outcome: sensitivity and specificity for detection of Cervical Intra-epithelial Neoplasia grade two or higher or grade three or higher on index test and comparator test(s). Several large systematic reviews and meta-analyses addressing these Populations, Interventions, Comparators, and Outcomes were included in the assessment. De novo systematic evidence reviews were conducted for data not adequately summarized in existing reviews. In contrast to previous Enduring Guidelines efforts, primary risk data were not used to develop the recommendations because no large prospective US data exist for the approved human papillomavirus self-collection test configurations.