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

Monitor viral load to improve patient management

Monitoring HBV viral load with high specificity and accuracy

HBV DNA detection and viral load measurement are essential for the diagnosis, decision to treat and subsequent monitoring of patients.1 The Roche COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 is a fully automated viral load quantitative hepatitis B test used in the management of patients with chronic hepatitis B infection undergoing antiviral therapy.2

It provides security in your results with high specificity and accuracy, using primers and probes targeting the highly conserved pre-core and core region.2

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, built-in AmpErase enzyme to prevent carryover contamination, and detection for a highly efficient laboratory workflow.1,2

Features

  • Broad linear range from 20 – 1.7 x 108 IU/mL
  • Broad coverage of all known HBV genotypes (A-H) including pre-core mutation
  • Low sample input volume of 650uL, for serum and plasma
  • 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)

Confident clinical decision making and increased laboratory efficiency

  • 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

(CE-IVD)

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.

(US-IVD)

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.

Performance

Parameters Performances
Sample type EDTA plasma, serum
Sample processing volume 500 µL
Analytical sensitivity
(LoD by hit rate of ≥ 95% ) in EDTA Plasma
20 IU/mL
Linear range 20 – 1.7 x 108 IU/mL
Specificity 100% with a confidence limit of 99.54%
Genotypes detected HBV genotypes A-H, precore mutant

A critical assessment tool for long-term patient monitoring

Discover robust, clinically relevant assay performance with a broad linear range, high sensitivity and optimal results within a fully automated workflow, with the COBAS® AmpliPrep/COBAS®TaqMan® HBV Test, v2.0

Reference:

  1. Journal of hepatology. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012;57(1):167-85.
  2. COBAS®AmpliPrep/COBAS®TaqMan®HBV Test, v2.0 Package Insert.