Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: High concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN

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• 作者：Maaike G. Dijkstra^a ; Danië ; lle A.M. Heideman^a ; Folkert J. van Kemenade^a ; Kees J.A. Hogewoning^b ; Albertus T. Hesselink^a ; Murië ; l C.G.T. Verkuijten^c ; W. Marchien van Baal^d ; Gatske M. Nieuwenhuyzen-de Boer^e ; Peter J.F. Snijders^a ; Chris J.L.M. Meijer^a ; ^{cjlm.meijer@vumc.nl}
• 关键词：hrHPV ; high-risk Human papillomavirus ; lrHPV ; low-risk Human papillomavirus ; CIN ; cervical intraepithelial neoplasia ; CIN2+ ; high-grade cervical intraepithelial neoplasia (CIN2/3) and cervical cancer (CIN2+) ; RLB ; reverse line blotting
• 刊名：Journal of Clinical Virology
• 出版年：2012
• 期刊代码：150_13866532
• 类别：med
• 出版时间：June, 2012
• 卷：54
• 期：2
• 页码：147-151
• 文件大小：234 K

摘要

Background

Studies have shown that self-sampling for hrHPV testing (HPV self-sampling) is highly acceptable to women, increases screening participation rate, and may therefore further reduce cervical cancer incidence. However, it is important to clinically validate HPV self-sampling procedures for screening purposes.

Objectives

Clinical validation of combined brush-based self-sampling with GP5+/6+-PCR EIA for primary cervical screening. In addition, HPV type-specific agreement between sample types and acceptability of brush-based self-sampling were evaluated.

Study design

135 women referred for colposcopy took a self-sample at home prior to vaginal- and cervical sampling by a gynaecologist. All women were biopsied for histology. HPV testing was done by GP5+/6+-PCR EIA, with genotyping by reverse line blotting (RLB). Acceptability of sampling methods was measured with a questionnaire.

Results

In this outpatient population, hrHPV test results showed good concordance between self-samples and physician-taken cervical scrapes (86%, k = 0.70), with sensitivities and specificities for CIN2+ that did not differ significantly (93%and 51%, 91%and 51%, respectively (P = 1.0)). The clinical sensitivity of brush-based self-sampling combined with GP5+/6+-PCR EIA hrHPV testing for detection of CIN2+ was non-inferior to that of hrHPV testing on physician-taken cervical samples (P = 0.018). In addition, hrHPV genotyping results were highly concordant between sample types, with almost perfect agreement for HPV16 (k = 0.81) and HPV18 (k = 0.92). Finally, 91%of participants described brush-based self-sampling as easy-to-use.

Conclusions

Brush-based self-sampling in combination with GP5+/6+-PCR EIA hrHPV testing is acceptable to women and valid for assessing the risk of CIN2+ in comparison to hrHPV testing on physician-taken scrapes. In addition, there was high concordance of HPV genotyping results. Therefore, this HPV self-sampling procedure may be considered for use in routine cervical screening.