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

Improve patient management and treatment success

Fully automated viral load quantitative hepatitis B test used in the management of patients with chronic hepatitis B infection 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, all combined with fully automated sample extraction and real-time PCR amplification and detection for a highly efficient laboratory workflow.

Features and Benefits

Features

  • State of the art assay with robust performance
  • High specificity and accuracy
  • Broad linear range from 20 – 1.7 x 108 IU/mL
  • Targets the highly conserved pre-core and core region
  • Broad coverage of all known HBV genotypes (A-H) including pre-core mutation
  • Tight precision at medically relevant decision points
  • Low sample input volume of 650uL, for serum and plasma
  • Built-in contamination control with AmpErase enzyme to prevent carryover contamination
  • Flexible batch size with continuous loading feature and interleave capability with core virology COBAS® TaqMan® assays (HIV-1, HBV, HCV Quant and HCV Qual and CMV)

Benefits

  • Delivers confidence in clinical decision making and improves ability to monitor patients throughout medical decision points.
  • Minimizes the need for repeat testing or dilutions
  • Avoid false positive results and ensure reliability at key medical decision points
  • Increase laboratory efficiency ensuring sample/data integrity while reducing hands-on time
  • Avoid risk of being affected by common drug resistance mutations
  • Workflow optimization with other core virology assays and testing flexibility

Intended Use

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 serum or plasma (EDTA), 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 antiviral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 must be interpreted within the context of all relevant clinical and laboratory findings.

Assay performance characteristics have been established for individuals treated with adefovir dipivoxil. Assay performance for determining the state of HBV infection has not been established.

The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.