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BMC Women's Health
Published in: BMC Women's Health 1/2018

Open Access 01-12-2018 | Technical advance

Performance of OncoE6 cervical test with collection methods enabling self-sampling

Authors: Amrei Krings, Anna M. Dückelmann, Lutz Moser, Johannes Gollrad, Maarten Wiegerinck, Johannes Schweizer, Andreas M. Kaufmann

Published in: BMC Women's Health | Issue 1/2018

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Abstract

Background

The paradigm shift from cytological screening to Human Papillomavirus (HPV)-based screening for cervical cancer allows the introduction of new technologies in sample collection and diagnostics. The OncoE6™ Cervical Test (OncoE6 Test) is a rapid, easy-to-use lateral flow method detecting HPV16/18 E6 oncoproteins that has proven to detect high-grade cervical lesions with high specificity. If compatible with self-collection samples, this technology might allow for decentralized screening of hard-to-reach populations.

Methods

For technical validation, cervicovaginal lavages were collected from 20 patients with confirmed HPV16+ or HPV18+ invasive cervical cancer. Cervical smears were collected by polyester-tipped swabs and cytobrushes. All samples were applied to the OncoE6 Test and cytobrush samples additionally genotyped.

Results

Lavage, swab, and cytobrush revealed concordant outcome in 18/20 samples. HPV types corresponded with the HPV genotyping by GP5+/6+ PCR analyses. Due to a rare mutation found in the E6 antibody binding site one sample was not detected, another sample had very low cellularity.

Conclusions

Overall, vaginal lavages are technically adequate for the OncoE6 Test. Combining self-sampling with oncoprotein rapid testing to detect women with highest risk for severe dysplasia or cancer may allow for secondary cancer prevention in settings where other screening modalities were unsuccessful to date.
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Metadata
Title
Performance of OncoE6 cervical test with collection methods enabling self-sampling
Authors
Amrei Krings
Anna M. Dückelmann
Lutz Moser
Johannes Gollrad
Maarten Wiegerinck
Johannes Schweizer
Andreas M. Kaufmann
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Women's Health / Issue 1/2018
Electronic ISSN: 1472-6874
DOI
https://doi.org/10.1186/s12905-018-0559-3

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