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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MDPI AG
2021
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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) |
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South Africa SelfCerv HPV cervical cancer self-sampling E6/E7 mRNA Medicine R |
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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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