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 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.
- 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
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.
|Sample type||EDTA plasma, serum|
|Sample processing volume||400 µL or 200 µL|
(LoD by hit rate of ≥ 95% ) in EDTA Plasma
|5 IU/mL (400 µL);
10 IU/mL (200 µL)
|Linear range||400 µL: 10 IU/mL – 1 x 109 IU/mL
200 µL: 10 IU/mL – 1 x 109 IU/mL
|Specificity in EDTA Plasma||100.0% (one-sided 95% confidence interval; 99.5%)|
|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. Learn more about cobas® HBV for the cobas® 4800 System.
- EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. Journal of hepatology. 2012;57(1):167-85.
- Hunt CM, et al. Clinical relevance of hepatitis B viral mutations. Hepatology. 2000;31(5):1037-44.
- cobas® HBV Test for use on the cobas® 4800 System Package Insert.