This article is more than 5 years old. Information may no longer be current.

Roche launches new assay for HBV

Roche Molecular Diagnostics announced the release of its new assay for hepatitis B virus infection, the cobas HBV Test, in countries accepting the CE mark, as part of their current cobas 4800 System.

According to a press release, the new diagnostic assay joins its other assays: HIV-1, HCV and HCV Genotyping Tests, for use on Roche’s cobas 4800 System. The system is used to provide more efficacious results in laboratories.

The cobas HBV assay is a test designed to quantify HBV DNA in a patient’s blood and provide broad coverage of HBV genotypes A through H, including precore mutations. These elements will enable physicians to assess a patient’s response to antiviral therapy, according to the release.

“The state-of-the-art cobas HBV assay enables clinicians to follow best practices in patient care with standardized viral load measurements, across a broad range of genotypes, with high sensitivity,” Paul Brown, head of Roche Molecular Diagnostics, said in the release. “Having the assay on the cobas 4800 System helps laboratories provide reliable results for an expanded menu of assays — from microbiology and women’s health to virology solutions — in order to enable confident patient management.”

A previous press release stated that HIV-1, HCV and HCV Genotyping Test assays can run simultaneously on the cobas 4800 System with two different sample processing volumes (200 or 400 µL), including 200 µL for the HIV-1 Test, 400 µL for the HCV Test and 400 µL for the HCV Genotyping Test. This workflow will increase “flexibility for patient sample management,” according to the release.

The new cobas HBV test can be added into this simultaneous approach with options for 200-µL and 400-µL input volume.

Disclosure: Brown is employed by Roche Molecular Diagnostics.