www.fdanews.com/articles/202044-biom%C3%A9rieuxs-tuberculosis-test-gets-european-clearance
bioMérieux’s Tuberculosis Test Gets European Clearance
March 26, 2021
bioMérieux has obtained CE mark certification for its TB Interferon-Gamma Release Assay (IGRA) test, an assay used to diagnose latent tuberculosis infection.
The assay is performed on the company’s VIDAS 3 system, using a single whole blood sample tube without requiring any manual sample preparation.
The test is fully automated from sample-to-result interpretation and is an improvement over other IGRA tests that require multiple manual steps, the company said.