Molecular Test for Hepatitis C Virus

The HCV assay has received the CE Mark.

Quantitative measurements of HCV levels in plasma or serum have been shown to be an essential parameter in the prognosis and management of HCV-infected patients. An initial assessment of viral load can guide a decision to begin antiviral therapy, while monitoring HCV RNA levels during therapy can influence its duration.

The HCV test is the result of a joint venture encompassing two companies: Abbott Laboratories (Abbott Park, IL, USA) and Celera Diagnostics (Alameda, CA, USA). Celera's focus is primarily on assay development and genetic marker discovery and validation, while Abbott's focus is on product development and marketing, serving as the worldwide distributor of the products developed by the alliance.

The HCV assay has been developed for use on the Abbott m2000 system, an automated instrument using real-time PCR technology. "One of the key impediments of molecular testing we've addressed with the Abbott m2000 system is the complex and heavily manual procedures required, from the preparation of patient samples to the analysis of data,” explained Edward Michael, president, Abbott Molecular. "By taking automation to another level, we're helping molecular laboratories deliver patients' test results faster, easier, and more accurately.”

The Abbott m2000 system purifies the nucleic acid (RNA) from the specimen and automatically combines this with the assay reagents. The system's software has been specifically designed to be user-friendly and data are automatically calculated to provide highly reliable patient results for HCV viral load testing. In real-time PCR, the amplified DNA sequences are detected throughout the PCR process, instead of at the end of the amplification process. The instrument and reagents allow labs to provide highly accurate test results more quickly, increasing productivity and reducing human error.

"It is among the most sensitive viral load tests available today, with a broad dynamic range, capable of detecting HCV RNA in plasma down to as few as 12 IU (international units) of HCV RNA per milliliter,” noted John Robinson, Ph.D., director of research and development, Abbott Molecular. "With a broad dynamic range that quantitates specimens as high as 100 million IU of RNA per milliliter, the need for sample dilutions and additional testing is virtually eliminated.”





Related Links:
Abbott Molecular
Celera Diagnostics