Roche Diagnostics announced the release of new assays for HIV-1, hepatitis C virus infection and genotyping hepatitis C virus infection in countries accepting the CE mark1, as part of their current Cobas 4800 System.
According to a press release, the new diagnostic assays can be used simultaneously on Roche’s Cobas 4800 System, which is used to provide faster and more efficacious results among laboratories and enable faster clinical decisions.
Each assay has its own unique function. Cobas HCV will protect against mutations that can occur in the viral genome and can also accurately detect and quantify HCV RNA with state-of-the-art sensitivity. Cobas HCV genotyping is a real-time polymerase chain reaction-based test for identifying HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human serum. Cobas HIV simultaneously amplifies and detects two separate regions of the HIV-1 genome not subjected to selective drug pressure, which would allow for more efficacious results for quantifying amounts of HIV-1 RNA in the blood.
The assays can run simultaneously on the Cobas 4800 System with two different sample processing volumes (200 or 400 µL), including 200 µL for HIV-1, 400 µL for HCV and 400 µL for HCV genotyping. This workflow will increase “flexibility for patient sample management,” according to the release.
“With the addition of these assays to the Cobas 4800 menu, more laboratories have access to advanced virology assays that provide reliable results for confident patient management,” Roland Diggelmann, chief operating officer at Roche Diagnostics, said in the release. “As the global market leader, we are also pleased to introduce Cobas HCV genotype test which accurately identifies HCV genotypes and helps optimize treatment of hepatitis C patients.”
The release further states that a Cobas hepatitis B virus assay is currently in the works and will complete the portfolio of viral load monitoring and genotyping assays for the Cobas 4800 System.
Disclosures: Diggelmann is employed by Roche Diagnostics.