The cobas® 4800 Human Papillomavirus (HPV) Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies HPV16 and HPV18 while concurrently detecting the other high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels. Specimens are limited to cervical cells collected in cobas® PCR Cell Collection Media (Roche Molecular Systems, Inc.), PreservCyt® Solution (Hologic Corp.) and SurePath® Preservative Fluid (BD Diagnostics-TriPath).
Indications for use of the cobas® 4800 HPV Test are:
The results from the cobas® HPV Test, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of the cobas® HPV Test are not intended to prevent women from proceeding to colposcopy.