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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| Format: | Article |
| Language: | English |
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MDPI AG
2021-10-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/10/21/4817 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-10T05:59:39Z |
| format | Article |
| id | doaj.art-4ebf7f6868f04990b141a183e050a92a |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T05:59:39Z |
| publishDate | 2021-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-4ebf7f6868f04990b141a183e050a92a2023-11-22T21:03:00ZengMDPI AGJournal of Clinical Medicine2077-03832021-10-011021481710.3390/jcm10214817Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South AfricaTeboho Amelia Tiiti0Tebogo Loraine Mashishi1Varsetile Varster Nkwinika2Kgotlaethata Aaron Molefi3Ina Benoy4Johannes Bogers5Selokela Gloria Selabe6Ramokone Lisbeth Lebelo7Department of Virological Pathology, Sefako Makgatho Health Sciences University, Pretoria 0204, South AfricaDepartment of Virological Pathology, Sefako Makgatho Health Sciences University, Pretoria 0204, South AfricaDepartment of Virological Pathology, Sefako Makgatho Health Sciences University, Pretoria 0204, South AfricaDepartment of Obstetrics and Gynaecology, Sefako Makgatho Health Sciences University, Pretoria 0204, South AfricaLaboratory of Cell Biology and Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerpen, BelgiumLaboratory of Cell Biology and Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerpen, BelgiumDepartment of Virological Pathology, Sefako Makgatho Health Sciences University, Pretoria 0204, South AfricaDepartment of Virological Pathology, Sefako Makgatho Health Sciences University, Pretoria 0204, South AfricaBackground: 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.https://www.mdpi.com/2077-0383/10/21/4817South AfricaSelfCervHPVcervical cancerself-samplingE6/E7 mRNA |
| spellingShingle | 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 Journal of Clinical Medicine South Africa SelfCerv HPV cervical cancer self-sampling E6/E7 mRNA |
| 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_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_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_sort | evaluation of ilex selfcerv for detection of high risk human papillomavirus infection in gynecology clinic attendees at a tertiary hospital in south africa |
| topic | South Africa SelfCerv HPV cervical cancer self-sampling E6/E7 mRNA |
| url | https://www.mdpi.com/2077-0383/10/21/4817 |
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