Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa

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 a...

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Autores principales: Teboho Amelia Tiiti, Tebogo Loraine Mashishi, Varsetile Varster Nkwinika, Kgotlaethata Aaron Molefi, Ina Benoy, Johannes Bogers, Selokela Gloria Selabe, Ramokone Lisbeth Lebelo
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Publicado: MDPI AG 2021
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Acceso en línea:https://doaj.org/article/4ebf7f6868f04990b141a183e050a92a
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spelling oai:doaj.org-article:4ebf7f6868f04990b141a183e050a92a2021-11-11T17:29:23ZEvaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa10.3390/jcm102148172077-0383https://doaj.org/article/4ebf7f6868f04990b141a183e050a92a2021-10-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/4817https://doaj.org/toc/2077-0383Background: 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<sup>®</sup> 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.Teboho Amelia TiitiTebogo Loraine MashishiVarsetile Varster NkwinikaKgotlaethata Aaron MolefiIna BenoyJohannes BogersSelokela Gloria SelabeRamokone Lisbeth LebeloMDPI AGarticleSouth AfricaSelfCervHPVcervical cancerself-samplingE6/E7 mRNAMedicineRENJournal of Clinical Medicine, Vol 10, Iss 4817, p 4817 (2021)
institution DOAJ
collection DOAJ
language EN
topic South Africa
SelfCerv
HPV
cervical cancer
self-sampling
E6/E7 mRNA
Medicine
R
spellingShingle South Africa
SelfCerv
HPV
cervical cancer
self-sampling
E6/E7 mRNA
Medicine
R
Teboho Amelia Tiiti
Tebogo Loraine Mashishi
Varsetile Varster Nkwinika
Kgotlaethata Aaron Molefi
Ina Benoy
Johannes Bogers
Selokela Gloria Selabe
Ramokone Lisbeth Lebelo
Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa
description 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<sup>®</sup> 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.
format article
author Teboho Amelia Tiiti
Tebogo Loraine Mashishi
Varsetile Varster Nkwinika
Kgotlaethata Aaron Molefi
Ina Benoy
Johannes Bogers
Selokela Gloria Selabe
Ramokone Lisbeth Lebelo
author_facet Teboho Amelia Tiiti
Tebogo Loraine Mashishi
Varsetile Varster Nkwinika
Kgotlaethata Aaron Molefi
Ina Benoy
Johannes Bogers
Selokela Gloria Selabe
Ramokone Lisbeth Lebelo
author_sort Teboho Amelia Tiiti
title Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa
title_short Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa
title_full Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa
title_fullStr Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa
title_full_unstemmed Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa
title_sort evaluation of ilex selfcerv for detection of high-risk human papillomavirus infection in gynecology clinic attendees at a tertiary hospital in south africa
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/4ebf7f6868f04990b141a183e050a92a
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