System Portfolio Includes High Medical Value Virology Assays

New commercial virology assays offer the latest generation of performance with dual target technology for Human immunodeficiency virus 1 (HIV-1) and dual probe technology for Hepatitis C virus (HCV).

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 in countries accepting the Conformité Européenne (CE) marking.

All of the new virology assays can run simultaneously on the cobas 4800 System (Roche Molecular Diagnostics; Basel, Switzerland) with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value in vitro diagnostic (IVD) assays, making it the ideal solution for a highly efficient laboratory.

The three new virology assays can run simultaneously on the cobas 4800 System with two different sample processing volumes for HIV-1 and HCV (200 µL and 400 µL) and only 400 µL for HCV genotyping test (GT) streamlining workflow while increasing flexibility for patient sample management. The cobas HIV-1 is built upon the dual-target assay design and the test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 ribonucleic acid (RNA) in a patient's blood.

The cobas HCV Genotyping is a highly accurate and sensitive real-time polymerase chain reaction (PCR)-based test 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. The cobas HCV employs a unique 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 Hepatitis C virus ribonucleic acid (RNA) with state-of-the-art sensitivity in order to confirm active HCV infection or assess a patient’s response to antiviral therapy.

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Roche Molecular Diagnostics