Molecular System Offers Quantitative Monitoring of Hepatitis Viruses

A molecular system for monitoring hepatitis virus load uses branched DNA (bDNA) technology that simplifies testing by eliminating nucleic acid extraction and reducing the risk of cross-contamination.

Known as the Versant 440 molecular system, it was designed for flexible walk-away automation. Its single room technology and consolidated footprint allow the system the flexibility to fit anywhere in the clinical laboratory. Workflow is streamlined by integrating bar code data entry, automated reagent processing, signal amplification detection, and a laboratory-information-system interface for downloading patient work lists and results.

Siemens Healthcare (Deerfield, IL, USA) announced that its Versant 440 molecular system has been approved for marketing by the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) for use with the Versant HCV RNA 3.0 assay for management of hepatitis C virus- (HCV)-infected patients undergoing antiviral therapy. The Versant 440 molecular system represents the next generation in automated viral load testing, providing laboratories with greater throughput and less hands-on time, maximizing productivity to meet the evolving needs of the clinical laboratory.

The Versant HCV 3.0 assay has a high level of reproducibility, allowing viral load changes to be distinguished accurately, enhancing hepatitis C viral load management. The HCV RNA 3.0 assay, when run on the Versant 440, demonstrates excellent precision across the entire reporting range and equivalent detection of all HCV RNA genotypes.


Related Links:
Siemens Healthcare
U.S. Food and Drug Administration