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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: May 19, 2011

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Abbott said this week that the US Food and Drug Administration has approved its RealTime HCV assay for measuring hepatitis C viral load.

The real-time PCR-based test runs on the Abbott m2000 platform and measures HCV in human plasma or serum. According to Abbott, it is the only test for which the limit of detection and limit of quantitation are the same at 12 IU/mL. At this level of sensitivity, physicians can measure very low levels of the virus in order to determine whether antiviral drug treatments are working, the company added.

The RealTime HCV assay is used to help manage HCV-infected patients undergoing antiviral therapy. It measures HCV RNA levels at baseline and during treatment, and can be used to predict sustained and non-sustained virological response to HCV therapy, Abbott said.

Test results must be interpreted "within the context of all relevant clinical and laboratory findings," the company said, adding that the test is not for screening blood, plasma, serum, or tissue donors for HCV. It also is not for use as a diagnostic for the presence of the virus.

In a statement, Joseph Jacobs, associate medical director for Abbott, said that the addition of the HCV assay to the m2000 system makes Abbott the only molecular diagnostic company in the US offering viral load assays for HIV, HBV, and HCV, and a combination test for chlamydia and gonorrhea on one platform.

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