NOWDiagnostics Gets CE Mark for COVID-19 Antibody Fingerstick Test
NOWDiagnostics has received CE mark certification for its ADEXUSDx COVID-19 antibody fingerstick diagnostic test.
The self-contained test uses a fingerstick blood sample to measures a patient’s SARS-CoV-2 antibody levels in 15 minutes and requires no buffers, reagents or additional equipment. The test has a sensitivity of 95.6 percent and a specificity of 98.5 percent.
The company is launching the test in Europe for use in healthcare settings, including clinics and emergency rooms, and will initiate trials evaluating its over-the-counter use.
NOWDiagnostics has also filed for Emergency Use Authorization from the FDA.