Gates open research
Analytical performance and clinical usability of a low-cost vaginal swab for sensitive detection of high-risk human papillomavirus
By Omballa V, Luchetta J, Amaru R and 7 others.
Abstract
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.