在南非一家三级医院对妇科门诊患者使用ILEX SelfCerv检测高危型人乳头瘤病毒感染的评估。
Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa.
作者信息
Tiiti Teboho Amelia, Mashishi Tebogo Loraine, Nkwinika Varsetile Varster, Molefi Kgotlaethata Aaron, Benoy Ina, Bogers Johannes, Selabe Selokela Gloria, Lebelo Ramokone Lisbeth
机构信息
Department of Virological Pathology, Sefako Makgatho Health Sciences University, Pretoria 0204, South Africa.
Laboratory of Cell Biology and Histology, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Antwerpen, Belgium.
出版信息
J Clin Med. 2021 Oct 20;10(21):4817. doi: 10.3390/jcm10214817.
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.
背景
SelfCerv自行采集宫颈健康筛查试剂盒（南非约翰内斯堡的Ilex Medical Ltd.公司）是一种涂抹式棉塞，设计用于自行采集阴道样本，以检测人乳头瘤病毒（HPV）脱氧核糖核酸（DNA）和E6/E7信使核糖核酸（mRNA）。本研究旨在评估SelfCerv涂抹式棉塞在宫颈癌筛查中检测高危型HPV（hr-HPV）的性能，并进一步调查女性对自行采样的体验和偏好。
方法
在南非豪登省一家三级医院，从527名年龄≥18岁的妇科门诊患者中采集阴道样本。使用SelfCerv试剂盒自行采集样本，随后由医护人员使用Cervex-Brush Combi采集宫颈管样本。参与者完成了一份关于自行采样体验和偏好的自填式问卷。分别使用雅培实时hr-HPV检测法和Aptima hr-HPV mRNA检测法对两份样本进行14种高危型HPV及E6/E7 mRNA检测。
结果
527对配对样本之间hr-HPV分型的总体一致性良好（87.1%；κ=0.74），敏感性高（86.2%），特异性高（88.0%）。HPV-16（96.4%；κ=0.83）的一致性率高于HPV-18（96.8%；κ=0.72）和其他12种hr-HPV（86.5%；κ=0.72）。285对检测E6/E7 mRNA的样本对显示一致性一般（70.2%；κ=0.34）。此外，据报告自行采样舒适（90.5%）且无痛（86.7%），88.4%的女性更喜欢自行采集。
结论
自行采集的样本与医护人员采集的样本在检测hr-HPV DNA方面一致性良好，且该方法深受女性青睐。在基于诊所的常规宫颈癌筛查中，使用SelfCerv自行采样可作为医护人员采样的替代方法。
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