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Roche Hepatitis B Immunoassay Receives CE Mark

NEW YORK – Roche announced on Monday that its hepatitis B immunoassay has received CE marking and is available for use in countries accepting the regulatory designation. 

The Elecsys HBeAg Quant test determines both the presence and quantity of the hepatitis B E antigen in human serum and plasma. It can be used as an early marker of acute hepatitis B infection or as an indicator of chronic active hepatitis when taken in combination with other laboratory results and clinical information, Roche said in a statement. 

The immunoassay, which received CE marking last week, can also be used for treatment monitoring and will complement existing hepatitis B markers, Roche noted. A positive result can be used to determine the patient's disease phase, assess the activity of the virus in the liver, and indicate the risk of progressive liver disease and hepatocellular carcinoma, Roche said. The test runs on the firm's Cobas E analyzers.