Automated RT-PCR Platform Quantifies Hepatitis C RNA in Blood

Real-time polymerase chain reaction (PCR) technology is used to quantify the amount of hepatitis C virus (HCV) RNA in a patient's blood. Physicians use HCV viral load testing results to establish a baseline level of HCV infection and to serially monitor viral load levels and treatment effectiveness in patients undergoing therapy.

Performed on Roche's (Basel, Switzerland) Cobas AmpliPrep/ Cobas TaqMan, the HCV viral load test is designed for use on a fully automated, real-time PCR platform, which provides sample-in/results-out capability. The platform is flexible and customizable to meet the space and workflow needs of any laboratory. In the United States, more than 130 laboratories already utilize this fully automated platform for HIV testing

The Cobas AmpliPrep/Cobas TaqMan HCV test has been approved for use in the United States by the U.S. Food and Administration (FDA; Rockville, MD, USA). "We are pleased to offer this new solution for laboratories and physicians to optimize their turnaround time, workflow, and patient care with simultaneous processing of human immunodeficiency virus [HIV] and HCV patient samples,” said Daniel O'Day, president and CEO of Roche Molecular Diagnostics.

The new test offers a broad dynamic range from high levels of virus in a patient's blood to the "undetectable” low levels of viremia--the goal of therapy. To ensure accurate quantification, the test has been calibrated to World Health Organization (WHO; Geneva, Switzerland traceable standards and can detect down to 18 IU/ml with 100% certainty. In a 1,281 patient clinical trial, the Cobas AmpliPrep/Cobas TaqMan HCV test confirmed the importance of viral load testing to personalize hepatitis C patient care by accurately predicting treatment response, from onset of therapy through end of treatment.

Approximately 8,000-10,000 people in the United States die each year from HCV-related liver disease. An estimated 3.2 million persons in the United States have chronic HCV infection. Hepatitis C infections can range in severity from a mild or acute illness lasting a few weeks to a serious, lifelong, or "chronic” illness. Chronic hepatitis C infection can result in long-term health problems, including liver damage, liver failure, liver cancer, or even death.

Roche is one of the world's leading healthcare groups in the fields of diagnostics and pharmaceuticals. The company is an innovator of products and services for the early detection, prevention, diagnosis, and treatment of diseases.

Related Links:
Roche
U.S. Food and Administration
World Health Organization