Roche Receives CE Mark for Elecsys Anti-HEV IgM and IgG Chemiluminescent Immunoassays

Source: 360Dx

On November 16, Roche announced that its two serological tests for hepatitis E have received CE certification.

The company has launched the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays, which received CE certification last month. These tests detect hepatitis E virus IgM and IgG antibodies in human serum and plasma and can assist in diagnosing acute or recent hepatitis E infections, according to a statement by Roche. The fully automated assays are compatible with Roche’s Cobas E 411 analyzer, Cobas E 601/602 modules, as well as the Cobas E 402 and Cobas E 801 analyzer modules.

Roche pointed out that, compared with manual testing, these assays require less sample volume and can deliver results within 18 minutes.

In a multi-center study testing more than 8,900 samples, the overall relative sensitivity of the IgM test was 98.7%, and the overall specificity was 99.4%. The sensitivity of the IgG test was 99.1%, and the specificity was 99.8%.

The new test, together with Roche's Elecsys tests for hepatitis A, B, and C, completes the combined test panel used for the differential diagnosis of acute hepatitis.

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