HBV RNA assay for research use only

Hepatitis B is a potentially life-threatening viral liver infection caused by the Hepatitis B virus (HBV).

The World Health Organization estimates that 296 million people were living with chronic HBV infection in 2019, with 1.5 million new infections.¹ HBV RNA is a promising biomarker for researchers and clinicians working to better understand HBV disease levels and progression.

cobas^®HBV RNA can be used to support scientific research to understand the potential uses of this new biomarker.

cobas^® HBV RNA for use on the cobas^® 5800/6800/8800 Systems is an automated real-time RT-PCR assay for the in vitro quantitative detection of circulating HBV RNA in EDTA plasma and serum.

cobas^®HBV RNA is intended for research use only and is not for use in diagnostic procedures.

Benefits of the cobas® HBV RNA test

Robust design

Robust assay design to ensure accurate and reliable results

Scalability

Benefit from fully automated cobas^® 5800/6800/8800 Systems and an industry leading menu

Automation

Designed and optimized for use on the cobas^® 5800/6800/8800 Systems, enabling absolute sample to result automation

Key parameters*

Sample type

EDTA plasma, serum
Kit configuration

192 test cassette
Minimum amount of sample required

350 µL
Sample processing volume

200 µL
System software

cobas^® 6800/8800 System Software 1.4 or higher
cobas^® 5800 SW 1.0.2 and higher
Test duration

Results are available within less than 3.5 hours after loading the sample on the system
Open kit stability

90 days from first usage

*cobas^® HBV RNA for use on the cobas^® 5800/6800/8800 Systems for Research use only. Not for use in diagnostic procedures. Instructions for use. Pleasanton, CA, Roche Molecular Systems, 2022.

Intended use

cobas^®5800/6800/8800 Systems (RUO)

cobas^® HBV RNA for use on the cobas^® 5800/6800/8800 Systems (cobas^® HBV RNA) is an automated real-time RT-PCR assay for the in vitro quantitative detection of circulating HBV RNA in EDTA plasma and serum.

cobas^® HBV RNA is intended for research use only and is not for use in diagnostic procedures.

cobas^® HBV RNA can be used to support scientific research to understand the potential use of this new biomarker.

cobas^® HBV RNA is a quantitative automated real-time RT-PCR test that is run on the cobas^® 5800/6800/8800 Systems. cobas® HBV RNA enables the detection and quantitation of HBV RNA in EDTA plasma and serum of infected specimens. The viral load is quantified against a non-HBV RNA quantitation standard (RNA-QS), which is introduced into each specimen during sample processing.

Registration status

Research Use Only. Not for use in diagnostic procedures.

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

https://www.who.int/news-room/fact-sheets/detail/hepatitis-b. Accessed 17 Aug 2022.

cobas® HBV RNA (RUO)

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