FDA Approves The Abbott RealTime HCV assay for Hepatitis C

Abbott just announced that it has received approval from the U.S. Food and Drug Administration to market its RealTime PCR (polymerase chain reaction) test for measuring the viral load of hepatitis C (HCV), the leading cause of liver cancer in the United States.

The Abbott RealTime HCV assay, developed for use on the Abbott m2000 system, is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results from the RealTime HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. The Abbott RealTime HCV assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.

The Abbott RealTime HCV test offers precise measurement (quantitation) of HCV in human plasma or serum. It is a highly sensitive HCV viral load test and the only one for which the limit of detection (lowest level of virus that generates a positive result) and the limit of quantitation (lowest exact viral load measurement) are the same, 12 IU/mL. This level of sensitivity enables clinicians to measure very low levels of the HCV virus to gauge success of antiviral drug treatment for eradicating the infection.

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