Assay for Hepatitis C Viral Load

A new predictive test directly measures hepatitis C virus RNA levels in serum or plasma and is designed to aid doctors by guiding therapeutic decisions early in treatment. The assay has been cleared by the US Food and Drug Administration (FDA).

The importance of quantitative assessment of HCV RNA levels in predicting patients response to antiviral therapy is reflected in a recent statement from the US National Institutes of Health that early viral response is predictive of sustained viral response and should be a routine part of monitoring patients with genotype 1. Utilizing the viral load assay can help doctors decide if therapy should be discontinued, thereby avoiding the unnecessary side effects of prolonged treatment.

The test, called Versant HCV viral load assay, is the product of Bayer Diagnostics (Tarrytown, NY, USA; www.bayerdiag.com). The assay measures HCV viral levels using branched DNA (bDNA) signal amplification technology with the Bayer System 340 bDNA analyzer. The test measures HCV levels over a wide quantitation range and has been validated for all six HCV genotypes. Complementing this assay is Bayer's Versant HCV RNA qualitative assay for the determination of active HCV infection.

"Since this viral measurement is essential to the clinical decision to continue or discontinue therapy, a reliable result as generated by the Bayer HC bDNA assay affords great confidence in patient care,” said Eugene R. Schiff, M.D., director, Center for Liver Diseases, University of Miami School of Medicine (FL, USA).




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