cobas® HBV Test

cobas® HBV Test

Confidence and precision at medically relevant decision points

Delivering on clinical need requirements

Hepatitis B virus (HBV) DNA detection and viral load measurement are essential for treatment decisions and patient monitoring.1 cobas® HBV for use on the cobas® 4800/6800/8800 Systems provides security in your results with primers and probes targeting 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

cobas® HBV provides robust, clinically relevant assay performance with a broad linear range and high sensitivity, delivering optimal results throughout critical medical decision points and across all genotypes combined with a highly efficient laboratory workflow.1,3

Roche has been at the forefront of viral load monitoring tests for hepatitis and continues to provide a robust assay design to ensure accurate and reliable results to improve patient management and treatment success.

 

 

 

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.4

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.5

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Features

  • Excellent performance with serum and plasma specimens
  • Built-in contamination control with AmpErase enzyme to prevent carryover contamination
  • Excellent correlation to Roche COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0

A critical assessment tool for long term patient monitoring

Roche hepatitis assays deliver robust, clinically relevant performance with a broad linear range, high sensitivity and optimal results within a fully automated workflow.

Learn more about Roche's commitment to fighting viral hepatitis.

References

1. Janssen HLA. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012;57(1):167-85.

2. Hunt CM, et al. Clinical relevance of hepatitis B viral mutations. Hepatology. 2000;31(5):1037-44.

3. cobas® HBV Test for use on the cobas® 4800/6800/8800 System Package Inserts.

4. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. Journal of hepatology, 2012. 57(1)

5. Hunt, C.M., et al., Clinical relevance of hepatitis B viral mutations. Hepatology, 2000. 31(5): p. 1037-44

cobas® HBV Test Performance Summary

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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

cobas® 6800/8800 Systems** Performance

  • Sample type

    EDTA plasma, Serum

     

  • Minimum amount of sample required

    200 µL and 500 µL

  • Analytical sensitivity in EDTA plasma

    200 µL: 15.5 lU/mL 
    500 µL: 6.6 lU/mL

  • Linear range

    200 µL: 25 lU/mL - 1.0 x 10IU/mL
    500 µL: 10 lU/mL - 1.0 x 10IU/mL

  • Performance with HBV DNA-negative samples

    100.0% "Target Not Detected" (with a two-sided 95% confidence interval of 99.4% - 100%)

  • Genotypes detected

    HBV genotypes A-H, and predominant precore mutant

**US-IVD data only.

Intended use

Intended use

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

US-IVD

cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus DNA in human EDTA plasma or serum of HBV-infected individuals.

 

This 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 must be interpreted within the context of all relevant clinical and laboratory findings.

 

The cobas® HBV 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.

References: 
1. cobas® AmpliPrep/ cobas® TaqMan HBV test, v2.0 package insert 

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