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COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 * (CE-IVD)

A sensitive and fully automated platform improves viral load testing in serum and plasma

COBAS® TaqMan® 48 This highly sensitive test offers Roche's fully automated real-time PCR technology to achieve a broad dynamic range for the quantitative detection of hepatitis B virus (HBV) DNA in patient plasma and serum. The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The Test can detect genotypes A-H and pre-core mutants. It offers a broader dynamic range than previous generation tests, from as low as 20 IU/mL to as high as 1.7E+08 IU/mL, enabling physicians to improve viral load monitoring. The assay offers both serum and plasma specimen type and uses only a 650 μl sample processing volume.

The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 is an in vitro nucleic acid amplification test for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma and serum, using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated amplification and detection.

This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy.

Highly Sensitive & Accurate

The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0:

  • Offers improved ability for physicians to monitor patients throughout critical medical decision points
  • Offers use of serum or plasma specimen and requires half the sample input volume of previously available tests
  • Covers known HBV genotypes including pre-core mutants
  • Provides robust correlation to the previous version Roche Test
  • Is standardized against the WHO Standards for Hepatitis B virus and titer results are reported in International Units (IU/mL)
  • Can be run in combination with HIV and HCV on the same platform

Optimize patient treatment with efficient automated testing and standardized viral load measurements.

* Not available in the United States

 
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