High-risk Human Papillomavirus Messenger RNA Testing in Wet- And Dry- Self-Collected Specimens for High-Grade Cervical Lesion Detection in Mombasa, Kenya

Abstract

Background: Self-collection for high-risk HPV (hr-HPV) mRNA testing may improve cervical cancer screening. Hr-HPV mRNA with self-collected specimens stored dry could enhance feasibility and acceptance of specimen collection and storage; however, its performance is unknown. We compared the performance of hr-HPV mRNA testing with dry- as compared to wet-stored self-collected specimens for detecting ≥HSIL.

Methods: A total of 400 female sex workers in Kenya participated (2013-2018), of which 50% were HIV-positive based on enrollment procedures. Participants provided two self-collected specimens: one stored dry (sc-DRY) using a Viba brush (Rovers), and one stored wet (sc-WET) with Aptima media (Hologic) using an Evalyn brush (Rovers). Physician-collected specimens were collected for HPV mRNA testing (Aptima) and conventional cytology. We estimated test characteristics for each hr-HPV screening method using conventional cytology as the reference standard (≥HSIL detection). We also examined participant preference for sc-DRY and sc-WET collection.

Results: HR-HPV mRNA positivity was higher in sc-WET (36.8%) than sc-DRY samples (31.8%). Prevalence of ≥HSIL was 6.9% (10.3% HIV-positive; 4.0% HIV-negative). Sensitivity of hr-HPV mRNA for detecting ≥HSIL was similar in sc-WET (85%, 95% CI: 66-96), sc-DRY specimens (78%, 95% CI: 58-91), and physician-collected specimens (93%, 95% CI: 76-99).Overall, the specificity of hr-HPV mRNA for ≥HSIL detection was similar when comparing sc-WET to physician-collection. However, specificity was lower for sc-WET [66% (61-71)] than sc-DRY [71% (66-76)]. Women preferred sc-DRY specimen collection (46.1%) compared to sc-WET (31.1%). However, more women preferred physician-collection (63.9%) compared to self-collection (36.1%).

Conclusions: Sc-DRY specimens appeared to perform similarly to sc-WET for the detection of ≥HSIL.