The Siemens Healthineers SARS-CoV-2 Antigen (CoV2Ag) Assays are for in vitro diagnostic use in the qualitative detection of SARS-CoV-2 nucleocapsid in nasopharyngeal swab and anterior nasal specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from asymptomatic individuals, using the Atellica® IM Analyzer or ADVIA Centaur® XP/XPT Immunoassay Systems. These assays are intended as an aid in the diagnosis of patients with suspected SARS-CoV-2 infection.
Atellica IM and ADVIA Centaur SARS-CoV-2 Antigen Assays:
*This test has not been reviewed by the FDA. In the U.S., use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements.