Validating Human Papillomavirus Self-Collection Testing as an Alternative Approach to Cervical Cancer Screening

Summary: Introduction: Nearly all cervical cancers can be prevented by regular screening, yet screening adherence in the U.S. is on the decline. Many populations remain disproportionately underscreened due to multifactorial geographic, socioeconomic, and cultural barriers to screening. Primary human papillomavirus (HPV) testing has become the preferred cervical cancer screening modality recommended by the American Cancer Society. Currently, samples are collected by providers, but patient self-collection may mitigate obstacles faced with traditional collection methods. This study aims to compare and validate patient-collected with clinician-collected HPV samples in a metropolitan academic health system. Materials and Methods: During a 5-month period, paired self- and clinician-collected HPV samples were obtained from three outpatient clinics. Vaginal samples were self-collected using a COPAN FLOQswab 552c.80 swab, while clinicians collected routine cervical specimens. All samples underwent standard high-risk HPV DNA testing with the FDA approved Roche cobas 4800 HPV platform, with results classified as positive for HPV types 16/18, positive for other high-risk types, high-risk HPV negative, or invalid. Discordant sample pairs and randomly selected (~25%) other pairs were retested to evaluate reproducibility. The validation threshold was set at 80% positive agreement for overall HPV positivity. Results: Among 65 paired samples (Table 1), overall agreement was 90.8% (κ = 0.80) with positive agreement of 90.9% and negative agreement of 90.7%. The positivity ratio (1.09) indicated higher HPV prevalence in self-collected specimens. In repeat testing, clinician-collected sample agreement was 94.4% (κ = 0.91), while self-collected sample agreement was 76.5% (κ = 0.62). Conclusions: This study demonstrates high agreement between self- and clinician-collected HPV samples, supporting self-collection as a valid alternative option for cervical cancer screening. The introduction of HPV self-collection as a screening modality has the potential to increase screening rates and address barriers, particularly for underscreened and underserved populations.