Molecular cobas HBV Test

Hepatitis B : (HBV)

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Overview
Virology Hepatitis B HBV

Better Information for Patient Management

Robust, clinically relevant assay performance delivering quantitative
HBV DNA results with broad linear range and high sensitivity.

Highly optimized primer-probe selection

HBV DNA detection and viral load measurement are essential for the diagnosis, decision to treat and subsequent monitoring of patients.1

Roche primers and probes target the highly conserved pre-core and core regions of the HBV genome. The amplified region of the genome will not be affected by mutations that arise due to drug resistance.2

The HBV DNA Quantitative Test is based upon
Real-Time PCR Gold Standard Technology

The #1 choice that patients depend on

Receive the unmatched reliance of Roche PCR tests with 82% of US virology market share1 and over 116 million virological tests performed.2


Proven HBV test used in clinical trials of DAAs6,7,8,9,10,11,12

Generic Name Trade Name FDA approved
Interferon alfa-2b Intron® A 1991
Lamivudine Epivir® 1998
Adefovir dipivoxil Hepsera® 2002
Entecavir Baraclude® 2005
Peginterferon alfa-2a Pegasys® 2005
Telbivudine Tyzeka® 2006
Tenofovir Viread® 2008

Accurate as of November 2016.

Consistent performance you can rely on

The same linear range and specificity that you expect

 
Sample size 650 uL
Specificity 100%
Primer and probe design Highly conserved pre-core and core regions
Genotypes covered HBV Genotype A-H, and predominant pre-core mutant
Contamination control with AmpErase Yes

Evolutionary virology assay development program

Continuous innovation and menu expansion

cobas® HCV Test

Redefining HCV Viral Load Monitoring

The cobas® HCV test is the first and only FDA-approved HCV RNA viral load test for use as an aid in the diagnosis of active HCV infections.

cobas® HIV-1 Test

The Gold Standard in HIV-1 Molecular Testing

The cobas® HIV-1 test for viral load monitoring has a unique dual target design, amplifying two separate regions of the HIV-1 genome. The test provides confidence in results for patients living with the HIV-1 virus.

COBAS®
AmpliPrep/COBAS®
TaqMan® CMV Test

Standardization for patients. Simplification for laboratories.

The COBAS® AmpliPrep/COBAS® TaqMan® CMV test is a fully automated FDA-approved CMV test that delivers the benefits of standardization for clinical decision making, while providing improved efficiencies the laboratory truly needs.

References:
1. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. Journal of hepatology, 2012. 57(1)
2. Hunt, C.M., et al., Clinical relevance of hepatitis B viral mutations. Hepatology, 2000. 31(5): p. 1037-44
3. Data on File with Roche Diagnostics, September 2015.
4. cobas® AmpliPrep/ cobas® TaqMan HBV test, v2.0 package insert 05201586190
5. cobas® HBV package insert 07000979190-01EN ver 1.0.
6. INTRON® A (full prescribing information). Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889
7. EPIVIR® (full prescribing information). GlaxoSmithKline, Research Triangle Park, NC 27709
8. HEPSERA® (full prescribing information).Gilead Sciences, Foster City, CA 94404
9. BARACLUDE® (full prescribing information). Bristonl Meyers Squibb Company, Princeton, NJ 08543
10. PEGASYS® (full prescribing information). Hoffman-LaRoche, Inc South San Francisco, CA 94080
11. TYZEKA® (full prescribing information). Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936
12. VIREAD® (full prescribing information). Gilead Sciences, Foster City, CA 94404

Explore

Method correlation

Excellent correlation to COBAS® AmpliPrep/COBAS® TaqMan HBV Test, v2.01



cobas® HBV Test Intended Use2

COBAS® AmpliPrep/COBAS® TaqMan System & cobas® 6800/8800 Systems

The cobas® HBV test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral 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 cobas® HBV test must be interpreted within the context of all relevant clinical and laboratory findings.

The cobas® HBV test continues to deliver:

  • Tight precision at medically relevant decision points
  • Broad coverage of all known HBVgenotypes A-H including pre-core mutations
  • Built-in contamination control with AmpErase to prevent contamination carryover
  • Excellent performance in serum and plasma specimens

cobas® HBV Test Innovation Review

Key improvements in simplicity and functionality

 

Benefits

Sample type Serum, EDTA Plasma Serum, EDTA and PPT Plasma Increases flexibility of specimen types
CLIA complexity categorization High Moderate Increases flexibility of personnel
Linear range 20 – 1.0E+08 IU/mL 10 – 1.0E+09 IU/mL Reduces need to dilute and repeat
  Analytical sensitivity (LoD by probit analysis)
EDTA plasma (IU/mL) 9.8 6.6
Serum (IU/mL) 12.3 3.5
Tests per package 72 96 Reduces waste
Control packaging Included in kit Packaged separately
Onboard open reagent stability 64 hours 30 days

References:
1. Data on File with Roche Diagnostics, September 2015.
2. cobas® AmpliPrep/ cobas® TaqMan HBV test, v2.0 package insert
3. cobas® HBV package insert 07175507001-01EN, ver 1.0.

Performance

cobas® HBV Test Performance Summary

Gold Standard Performance with additional benefits

HBV CAP/CTM cobas® 6800/8800 systems
CLIA complexity categorization High Moderate
Linear range 20-1.0E+08 IU/mL 10–1.0E+09 IU/mL
Analytical sensitivity (LoD by probit analysis)  
EDTA plasma (IU/mL) 9.8 6.6
Serum (IU/mL) 12.3 3.5
Packaging All reagent components cassettes (72 tests) HBV test-specific reagent cassettes (96 tests)
Control packaging
(Unused portion of controls does not need to be discarded.)
Included in kit Packaged separately
Genotypes covered HBV Genotype A-H and predominant pre-core mutant HBV Genotoype A-H and predominant pre-core mutant
Primer and probe design Highly conserved pre-core and core regions Highly conserved pre-core and core regions
Sample types Serum, EDTA plasma Serum, EDTA and PPT plasma
Sample size 650 uL 650 uL
Contamination control with AmpErase Yes Yes
Specificity 100% 100%
Precision (SD across quantitative range) 0.08–0.14 0.03–0.14

Need additional performance data?

References:
1. cobas® AmpliPrep/ cobas® TaqMan HBV test, v2.0 package insert 05201586190.
2. cobas® HBV package insert 07000979190-01EN ver 1.0.

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