Objective: The authors compared the performance of a novel self-collect device with clinician-collected samples for detection of high-risk human papillomavirus (hrHPV).
Materials and methods: Eighty-two (82) participants were recruited from 5 clinical sites in the United States. Each participant performed self-collect sampling using the self-collect device followed by a standard of care clinician-collected sample. Both samples were evaluated for hrHPV using polymerase chain reaction (PCR)-based HPV assays. A subset of HPV-positive samples underwent dual staining (p16/Ki-67), and concordance was evaluated. Biopsy results collected per standard of care were recorded.
Results: On the Roche cobas assay, the preliminary positive percent agreement (PPA) and negative percent agreement (NPA) was 91%. Agreement for hrHPV using the BD OnClarity in PreservCyt was 100% PPA (n = 10), and 100% PPA, 93% NPA in SurePath. Dual-stain concordance was 93% (n = 16) overall, and 100% for HPV other genotypes. Seventy-one participants (n = 71; 89%) indicated they would feel confident using the self-collect device for screening if they knew they could get equal results, and 86% (n = 69) indicated that they would be more likely to get screened with this option.
Conclusions: The self-collect device shows high (>92%) positive and negative agreement for detection of HPV when compared with reference clinician-collected samples, with very high acceptability and preference. Furthermore, the self-samples collected with the self-collect device showed highly concordant results by dual stain, which is a novel and emerging application for a self-collected sampling device, thus enabling potential triage from 1 sample.
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