The COBAS® TaqMan® HBV Test For Use With The High Pure System (HPS) is an in vitro nucleic acid amplification test for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma, using the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyser for automated amplification and detection.
The COBAS® TaqMan® HBV Test is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection.