Evaluation of ilex selfcerv for detection of high‐risk human papillomavirus infection in gynecology clinic attendees at a tertiary hospital in south africa

Abstract

Background: The SelfCerv Self‐Collection Cervical Health Screening Kit (Ilex Medical Ltd., Johannesburg, South Africa) is an applicator tampon designed for self‐collection of vaginal samples for the detection of human papillomavirus (HPV) deoxyribonucleic acid (DNA) and E6/E7 messenger ribonucleic acid (mRNA). The study aimed to evaluate the performance of the SelfCerv applicator tampon for the detection of hr‐HPV for cervical cancer screening, and further to investigate women’s experiences and preferences regarding self‐sampling. Methods: Vaginal samples were collected from 527 gynecology clinic attendees aged ≥18 years at a tertiary hospital in Gauteng Province, South Africa. Self‐samples were collected using the SelfCerv kit, followed by endocervical samples collected by a healthcare professional using Cervex‐Brush® Combi. Participants completed a self‐administered questionnaire on self‐sampling experiences and preferences. Both samples were tested for 14 high‐risk (hr) HPV types and E6/E7 mRNA using the Abbott RealTime HR‐HPV and Aptima HR‐HPV mRNA assays, respectively. Results: The overall agreement for hr‐HPV typing between 527 paired samples was good (87.1%; κ =0.74) with high sensitivity (86.2%) and specificity (88.0%). HPV‐16 (96.4%; κ = 0.83) had higher agreement rate than HPV‐18 (96.8%; κ = 0.72) and the other 12 hr‐HPVs (86.5%; κ = 0.72). Two hundred and eighty‐five (285) sample pairs tested for E6/E7 mRNA showed fair agreement (70.2%; κ= 0.34). Furthermore, self‐sampling was reported as comfortable (90.5%) and painless (86.7%), with 88.4% of women preferring self‐collection. Conclusions: Self‐collected samples had good agreement with the healthcare professional‐collected samples for the detection of hr‐HPV DNA and the procedure was highly preferred by women. Self‐sampling using SelfCerv can be used as an alternative to healthcare professional sampling in clinic‐based routine cervical cancer screening.