Molecular Assay Monitors Hepatitis C Infections

A quantitative and automated assay can estimate the viral load in patients with Hepatitis C (HCV) infection and aids in management of the disease.

The HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of hepatitis C viral ribonucleic acid (HCV RNA) in human serum and plasma from HCV-infected individuals.

The RealTime PCR test 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 it can be utilized to predict sustained and nonsustained 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 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 RealTime HCV test, (Abbott Molecular, Abbott Park, Illinois, USA), offers precise quantitation of HCV in human plasma or serum. It is a highly sensitive HCV viral load test for which the limit of detection, the lowest level of virus that generates a positive result, and the limit of quantitation, the lowest exact viral load measurement, is the same at 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.

The RealTime HCV test runs on Abbott's automated molecular diagnostics system, the m2000, which utilizes RT-PCR technology for detecting and monitoring infectious diseases. The m2000 is designed to provide clinical laboratories a unique system that fully automates all of the complex and heavily manual steps often associated with molecular diagnostics. Abbott has received approval to market the RealTime HCV assay from the US Food and Drug Administration, (FDA, Silver Springs, MD, USA).

Related Links:
Abbott Molecular
US Food and Drug Administration