Abstract

Human papillomavirus (HPV) testing on vaginal self-collected and cervical clinician-collected specimens shows comparable performance. Self-sampling on FTA cards is suitable for women residing in rural settings or not attending regular screening and increases participation rate in the cervical cancer screening programme. We aimed to investigate and compare high-risk (HR)-HPV prevalence in clinician-collected and self-collected genital specimens as well as two different HPV tests on the clinician collected samples. A total of 737 women were recruited from two sites, a community health clinic (n = 413) and a referral clinic (n = 324) in the Eastern Cape Province. Cervical clinician-collected (FTA cards and Digene transport medium) and vaginal self-collected specimens were tested for HR-HPV using the hpVIR assay (FTA cards) and Hybrid Capture-2 (Digene transport medium). There was no significant difference in HR-HPV positivity between clinician-collected and self-collected specimens among women from the community-based clinic (26.4% vs 27.9%, p = 0.601) or the referral clinic (83.6% vs 79.9%, p = 0.222). HPV16, HPV35, and HPV33/52/58 group were the most frequently detected genotypes at both study sites. Self-sampling for HPV testing received a high positive response of acceptance (77.2% in the community-based clinic and 83.0% in referral clinic). The overall agreement between hpVIR assay and HC-2 was 87.7% (k = 0.754). The study found good agreement between clinician-collected and self-collected genital specimens. Self-collection can have a positive impact on a cervical screening program in South Africa by increasing coverage of women in rural areas, in particular those unable to visit the clinics and women attending clinics where cytology-based programs are not functioning effectively.

Highlights

  • Cervical cancer (CC), is the third-ranking cause of cancer disease with an estimated 569,847 cases leading to 311,365 deaths in women globally in 2018 [1]

  • Cervarix, which targets HPV16 and 18 [5], is the current human papillomavirus (HPV) vaccine used in schoolbased HPV vaccination programme in South Africa

  • The present study assessed the prevalence of high-risk human papillomavirus (HR-HPV) genotypes between self-collected and clinician-collected samples applied to FTA cards in women from a community-based clinic and a referral clinic in Eastern Cape, South Africa

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Summary

Introduction

Cervical cancer (CC), is the third-ranking cause of cancer disease with an estimated 569,847 cases leading to 311,365 deaths in women globally in 2018 [1]. About 12,983 new cervical cancer cases are diagnosed annually in South Africa (estimates for 2018) with an incidence of 31.7 per 100, 000 women [3, 4]. Cervarix, which targets HPV16 and 18 [5], is the current HPV vaccine used in schoolbased HPV vaccination programme in South Africa. This vaccine is expected to prevent at least 70% of CCs, both vaccinated women and unvaccinated women still need to continue to be screened for CC [5]. Pap smear screening is not readily available to most of the women in rural South Africa, including Eastern Cape Province [9, 10]. While CC screening programmes may be available in some local clinics, the majority of women are not aware of the available services and not likely to participate [11,12,13]

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