Papilloplex HR-HPV test has non-inferior clinical performance for detection of human papillomavirus infection: assessment using the VALGENT framework.

Last updated on 3-1-2024 by Marie Malingreau

Public Access

Published

Peer reviewed scientific article

English

Abstract:

AIM: The Papilloplex high-risk human papillomavirus (hrHPV) test (Genefirst, Oxford, UK) is a single tube real-time HPV test which provides multiplex detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5+/6+Enzyme ImmunoAssay (GP5+/6+EIA) using the VALGENT (VALidation of HPV GENotyping Tests) framework. METHODS: Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (1…

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