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COBAS^® TaqMan^® HBV Test For Use With The High Pure System

Improving patient management and treatment success

Hepatitis B virus (HBV) viral load quantification test used in the management of patients with chronic HBV undergoing antiviral therapy.

The test provides clinically relevant assay performance, and high sensitivity to deliver optimal results throughout critical medical decision points and across all genotypes.

The High Pure System Viral Nucleic Acid Kit allows for manual specimen preparation and the COBAS^® TaqMan^® Analyser for automated amplification and detection.

Features and benefits

Highly sensitive and accurate detection of all known genotypes and precore mutant
Broad dynamic range from 29 – 1.1x10⁸ IU/mL
Robust correlation to automated version COBAS^® AmpliPrep/COBAS^® TaqMan® HBV Test, v2.0
Minimizes testing errors with closed-tube amplification and detection on the COBAS^® TaqMan^® 48 Analyser
Improves result integrity, with inbuilt AmpErase enzyme reduces the risk of carryover contamination

Intended use

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.

Registration status

Canada-IVD; CE-IVD; US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

COBAS® TaqMan® HBV Test For Use With The High Pure System