Human papilloma virus IVDs

Intended purpose

The Xpert HPV Assay is a qualitative in vitro test for the detection of the E6/E7 region of the viral DNA genome from high risk Human Papillomavirus (HPV) in patient specimens. The test carries out multiplexed amplification of target DNA by real-time Polymerase Chain Reaction (PCR) of 14 high risk HPV types in a single analysis. Xpert HPV specifically identifies types HPV 16 and HPV 18/45 in two distinct detection channels, and reports 11 other high risk types (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68) in a pooled result. Specimens are limited to cervical cells collected in PreservCyt® Solution (Hologic Corp.). Cervical specimens collected in PreservCyt Solution that have been pretreated with Glacial Acetic Acid (GAA) to lyse excess red blood cells for cytology review have also been validated for use with the Xpert HPV Assay.