Abstract Background: HPV self-collection (SC) expands access to cervical cancer screening (CCS) and is equivalent to clinician-collected (CC) sampling. Longer-term histopathological data after SC is essential to ensure durable sensitivity. Methods: 599 enrolled in the SELF-CERV study evaluating the Teal Wand SC device and underwent SC and CC primary HPV testing at baseline (reported previously1), with SoC colposcopy and biopsy/excisions per guidelines. Pathology results were collected after baseline to 490 days for secondary analysis to fill the evidence gap. Diagnostic performance metrics (Sen, Sp, negative predictive value-NPV) and cumulative incidence rate (CIR) were calculated for SC versus CC HPV testing among those with high grade squamous intraepithelial lesions (HSIL) or worse (CIN2+). Results: Of 599 paired SC and CC HPV results, 280 (46.7%) had pathology results within 490 days of the study visit and 57 (9.5%) were diagnosed with CIN2+. SC HPV testing showed high Sen for CIN2+, equivalent to CC testing (TABLE), ratio of Sen 1.00, similar to that observed at baseline, ratio 1.00). The NPV amongst those with pathology was 96.7% (59/61). The CIR per genotype group was not statistically significantly different for SC and CC: HPV16 had the highest ratio both at the study visit (SC: 31%, CC: 33%) and at 16 months later (SC: 47%, CC: 49%), followed by 12 Other HPV (SC: 17%, CC: 18% at study visit; SC: 24%, CC: 25% at 16 mo), and HPV18 (SC Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 5106.
Sheth et al. (Fri,) studied this question.