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.

Knowledge of Human Papillomavirus and Cervical Cancer among Women Attending Gynecology Clinics in Pretoria, South Africa

“…This was an analytic cross-sectional study conducted between March 2016 and September 2018, targeting women aged 18 years and older attending gynecology clinics at a tertiary hospital in Pretoria, South Africa. The cross-sectional study has been described in detail previously [ 24 ]. The Sefako Makgatho Health Sciences Research and Ethics Committee approved the study (SMUREC/P/75/2016: IR).…”

Accuracy of HPV testing on self-collected and clinician-collected samples for different screening strategies in African settings: A systematic review and meta-analysis

“…Most common exclusion criterion was 'no comparable clinician testing' (n = 29), followed by 'no outcome measure of interest' (n = 3), 'no African setting' (n = 1), 'no full-text' available (n = 1) and 'doubtful quality' (n = 1). Finally, 28 articles were included in the systematic review [20, and 21 in the meta-analysis [36,38,[40][41][42][43][44][45][46][47][48][50][51][52][56][57][58][59][60][61][62] (see Fig. 1).…”

“…Study settings were mostly urban (n = 25), whereas three studies were conducted in rural regions [36,48,53]. Recruitment methods comprised 'clinic attendant' [36,38,40,41,43,45,47,49,51,[59][60][61][62] (n = 13), 'outreach' [39,42,46,50,52,54,56,57] (n = 8) and 'community' [20,37,44,48,53,55,58] (n = 7). Seven studies dealt with a population at risk [38,42,45,47,50,57,59] and 21 with a general population [20,36,37,[39][40][41]43,44,46,48,49,[51]...…”

“…Nine studies made use of 'brushes' [37,39-44, 50,60]. Two studies employed a tampon [45,62] for self-sampling and one a veil-device [58]. A careHPV cervical sampler found use in 2 publications [20,55].…”

“…Cohen's kappa was reported in 22 studies [36,38,[40][41][42][43][44][45][46][47][48][49][50][51][52][56][57][58][59][60][61][62]. Most of these studies (n = 19) sampled with an HPV test which detects high-risk HPV, two [41,56] used HPV-tests suitable for high-and lowrisk HPV detection.…”