Analytical performance and clinical usability of a low-cost vaginal swab for sensitive detection of high-risk human papillomavirus.

BACKGROUND

Cervical cancer remains a global health burden, with >600,000 new cases and 340,000 deaths reported in 2020. To reduce this burden, affordable and scalable human papillomavirus (HPV) diagnostics - ranging from at-home to centralized laboratory testing - are needed. Specimen collection plays a key role in analytical performance, sample integrity/stability, platform compatibility and user comfort.

METHODS

We evaluated the analytical performance and temperature stability of high-risk HPV (hrHPV) plasmid DNA and human cervical cancer cell lines on a low-cost Steripack XpressCollect flocked nylon swab using the Atila ScreenFire HPV risk stratification (RS) assay, the Cepheid Xpert HPV assay, and the Molbio Truenat HPV-HR Plus assay. We assessed the clinical usability among women seeking sexual and reproductive healthcare in New York, New York.

RESULTS

The Atila ScreenFire HPV RS assay was more sensitive in detection of HPV. We demonstrated statistically improved elution efficiency from the low-cost Steripack XpressCollect flocked nylon swab relative to Copan FLOQSwabs. Additionally, dry-stored flocked nylon swabs preserved sample integrity better than swabs stored in Tris-EDTA buffer over time with varying temperatures. Frozen HPV lysates remained stable for up to three months including during freeze/thaw cycles. Among healthcare provider-collected swabs, 7.5% were HPV positive and among the self-collected swabs, 20% were HPV positive. Of those with self-collected swabs, 97% had no previous self-swabbing experience, 71% preferred self-swabbing to healthcare provider-collected swabbing, 93% found it very easy or easy to self-swab and 100% were willing to provide self-swabbing at follow-up.

CONCLUSION

The use of dry-stored, nylon-flocked vaginal swabs paired with platform-agnostic assays, like the Atila ScreenFire HPV RS and other genotyping assay, offers a practical and robust solution for hrHPV genotyping in resource-limited settings. Additionally, self-swabbing using low-cost vaginal swabs was highly accepted and retained equivalent sensitivity, further justifying its widespread use in underserved communities.