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

Screening for cervical cancer has significantly reduced its incidence and mortality rate; the screening for human papillomavirus (HPV) infections is currently the primary screening method for cervical cancer, and can be performed using either clinician or self-collected vaginal specimens. Evidence has shown similar efficacy for screening with self-collected specimens compared with clinician-collected specimens, and the US Food and Drug Administration (FDA) recently approved primary HPV screening to include self-collected vaginal specimens. Guidance has not yet been published for the use of self-collected HPV tests in the United States. This consensus is a summary of recommendations for the use of HPV testing with self-collected samples for cervical screening and management put forth by the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. Evidence used in creating these recommendations included existing systematic reviews and meta-analyses comparing the sensitivity and specificity of self-collected vaginal specimens and clinician-collected specimens. A de novo analysis was also performed to evaluate testing performance, and both previous studies and this analysis showed that self-collected specimens showed high sensitivity and specificity and were comparable to clinician-collected specimens. Assessments of systematic reviews also showed that the sensitivity of self-collected specimens is great enough to use the same screening intervals as clinician-collected specimens. High agreement between the 2 methods has been repeatedly reported for PCR-based assays. For tests using signal amplification or mRNA to detect HPV, self-collected vaginal specimens had lower sensitivity than clinician-collected specimens. Published studies have not shown an impact of the choice of sampling device or buffer on the sensitivity and specificity of self-collected vaginal specimens compared with clinician-collected specimens, but there is wide variation in study methods, populations, and assay types. These cannot be modified in clinical practice, and thus the impact of these is not modifiable. Key emphasis points from the committee include the following: recommendations only apply to FDA-approved primary HPV screening tests using self-collected specimens, the previously published guidelines are still the standards for management, and the recommendations apply only to results for average-risk, asymptomatic individuals for routine screening. The recommendations themselves include (i) clinician-collected specimens are preferred, but self-collected specimens are acceptable, (ii) repeat testing is recommended after 3 years for self-collected specimens, (iii) when self-collected vaginal specimens are positive for HPV 16 and/or HPV 18, it is recommended that direct referral for colposcopy and cytology collection is implemented, (iv) positive results in any other combination should be confirmed with a clinician-collected cervical specimen for cytology or dual stain, (v) positive results for HPV 56, 59, or 66 and no other carcinogenic types, repeat testing is recommended after 1 year, and (vi) for surveillance, clinician-collected vaginal specimens are preferred, but self-collected specimens are acceptable. These results indicate that self-collected vaginal specimens for HPV screening can be a valuable tool for expanding access to cervical cancer screening. The FDA approval of self-collected HPV assays is crucial to this expansion of access, and studies have broadly shown that self-collected specimens have a similar sensitivity and specificity to clinician-collected samples in many cases. An important factor in cancer prevention beyond screening is follow-up, and future research should assess optimal follow-up periods to detect cervical cancer with self-collected specimens. (Summarized from Wentzensen N, Massad LS, Clarke MA, et al. Self-collected vaginal specimens for HPV testing: recommendations from the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. J Low Genit Tract Dis. 2025;29:144-152. doi: 10.1097/LGT.0000000000000885)