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Abbott RealTime PCR receives FDA approval

Abbott’s RealTime PCR (polymerase chain reaction) test has received the US Food and Drug Administration (FDA) marketing approval in the US.

The Abbott RealTime HCV assay, developed for use on the Abbott m2000 system, is intended for use as an aid in the management of hepatitis C (HCV)-infected patients undergoing antiviral therapy.

Abbott’s automated molecular diagnostics system, the m2000, uses real-time polymerase chain reaction (PCR) technology for detecting and monitoring infectious diseases.

The assay 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 the RealTime HCV test offers precise measurement (quantitation) of HCV in human plasma or serum.

The test’s 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.

Abbott Molecular Diagnostics Business head Stafford O’Kelly said the RealTime HCV assay detects and measures the six most common HCV genotypes by targeting an essential, highly conserved segment of the viral genome.

"It is a highly sensitive molecular assay and offers complete coverage of all HCV genotypes, as demonstrated in peer reviewed publications," O’Kelly said.

Abbott Molecular associate medical director Joseph Jacobs said the addition of the HCV assay to its automated m2000 system enables laboratories to consolidate sexually transmitted and infectious disease testing to improve workflow and productivity.