Roche, Basel, Switzerland, recently announced commercial availability of the Cobas HIV-1, HCV, and HCV genotyping (GT) assays in countries accepting the CE mark. These new molecular diagnostic assays increase the available menu on the Cobas 4800 system, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions.
The new virology assays offer the latest generation of performance with dual-target technology for human immunodeficiency virus (HIV)-1 and dual-probe technology for hepatitis C (HCV). The assays can run simultaneously on the system with two different sample processing volumes (200 ?L and 400 ?L) for HIV-1 and HCV, and 400 ?L for HCV GT, streamlining workflow while increasing flexibility for patient sample management.
The Cobas HIV-1 test simultaneously amplifies and detects two separate regions of the HIV-1 genome that are not subject to selective drug pressure, allowing for more reliable results to quantify the amount of HIV-1 RNA in a patient’s blood. The Cobas HCV test employs Roche’s dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome, and is designed to accurately detect and quantify HCV RNA with state-of-the-art sensitivity in order to confirm active HCV infection or assess a patient’s response to antiviral therapy. Finally, the HCV GT test uses polymerase chain reaction for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic HCV infection. Identification of the infecting genotype is required before a patient is prescribed antiviral therapy, as response to treatment correlates to the HCV genotype.
With these additions, the Cobas 4800 system now has a menu of 12 in vitro diagnostic assays, including tests to detect BRAF V600, EGFR, and KRAS mutations, C. difficile, chlamydia, herpes simplex 1 and 2, human papillomavirus, gonorrhea, methicillin-resistant Staphylococcus aureus, and Staphylococcus aureus.
Roland Diggelmann, Roche Diagnostics.
“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,” says Roland Diggelmann, chief operating officer at Roche Diagnostics.
In the coming months, Roche expects to complete the portfolio of viral load monitoring and genotyping assays for the Cobas 4800 system with the launch of the Cobas hepatitis B test.
For more information, visit Roche.
