NEW YORK – Roche announced on Thursday it received CE marking for two serology tests for hepatitis E.
The company has launched the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays, which received CE marking last month. The tests detect IgM and IgG antibodies to hepatitis E virus in human serum and plasma and can be used as aids to detect an acute or recently acquired hepatitis E infection, Roche said in a statement. The fully automated tests can be used with Roche's Cobas E 411 analyzer, Cobas E 601/602 modules, and the Cobas E 402 and Cobas E 801 analytical modules.
The assays require smaller sample volumes than manual tests and can return results in 18 minutes, Roche noted.
In a multicenter study that tested more than 8,900 samples, the IgM test had an overall relative sensitivity of 98.7 percent and overall specificity of 99.4 percent. The IgG test had sensitivity of 99.1 percent and specificity of 99.8 percent.
The new tests complete the test panel used for differential diagnosis of acute hepatitis, along with Roche's Elecsys tests for hepatitis A, B, and C.