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

• DOI: 10.1186/s12905-018-0559-3
• Publication Date: 2018-05-21T12:50:20Z
• Authors: Amrei Krings; Anna M. Dückelmann; Lutz Moser; Johannes Gollrad; Maarten Wiegerinck; Johannes Schweizer; Andreas M. Kaufmann
• Keywords: Cervical screening

The paradigm shift from cytological screening to Human Papillomavirus (HPV)-based for cervical cancer allows the introduction of new technologies in sample collection and diagnostics. OncoE6™ Cervical Test (OncoE6 Test) is a rapid, easy-to-use lateral flow method detecting HPV16/18 E6 oncoproteins that has proven detect high-grade lesions with high specificity. If compatible self-collection samples, this technology might allow decentralized hard-to-reach populations. For technical validation, cervicovaginal lavages were collected 20 patients confirmed HPV16+ or HPV18+ invasive cancer. smears by polyester-tipped swabs cytobrushes. All samples applied OncoE6 cytobrush additionally genotyped. Lavage, swab, revealed concordant outcome 18/20 samples. HPV types corresponded genotyping GP5+/6+ PCR analyses. Due rare mutation found antibody binding site one was not detected, another had very low cellularity. Overall, vaginal are technically adequate Test. Combining self-sampling oncoprotein rapid testing women highest risk severe dysplasia may secondary prevention settings where other modalities unsuccessful date.