Roche received FDA approval for the Cobas HBV and Cobas HCV viral load tests for use on the Cobas 6800 and Cobas 8800 systems.
Cobas HBV is a real-time PCR test designed to offer an expanded linear range coupled with broad coverage of all known HBV genotypes (A–H), including pre-core mutations with improved sensitivity. Cobas HCV employs Roche’s dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome. It is designed to accurately detect and quantify HCV ribonucleic acid of genotypes 1–6 with state-of-the-art sensitivity and is approved in the U.S. to confirm active HCV infection and assess a patient’s response to antiviral therapy. Cobas HCV can confirm active HCV infection and provide the baseline viral load at the same time. The two assays can run simultaneously on the Cobas 6800/8800 systems.
The Cobas 6800 and 8800 systems are fully integrated, automated solutions for routine molecular testing in the areas of viral load monitoring, donor screening, women’s health, and microbiology. The systems provide up to 96 results in less than 3.5 hours and a total of 384 results for the Cobas 6800 System and 960 results for the Cobas 8800 System in an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (Cobas 6800) and four hours (Cobas 8800) of walkaway time with minimal user interaction.
Roche Diagnostics, 800-428-5074