www.fdanews.com/articles/190312-abbotts-hbv-surface-antigen-test-earns-ce-mark
Abbott’s HBV Surface Antigen Test Earns CE Mark
February 21, 2019
Abbott has been handed the CE Mark for its Determine HBsAg2 diagnostic test, a device used for detecting hepatitis B surface antigens in a patient’s blood.
The portable diagnostic test — which provides results in 15 minutes — can be used with ease in any healthcare setting and has an analytical sensitivity of 0.1 IU/ml.
Patients can provide blood, plasma or serum for the diagnostic test to determine if they are infected with the virus and require treatment.