For Professional Use Only. For In Vitro Diagnostic Use Only. For Emergency Authorization Use Only. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.
The Pinnacle Cov-ID RAD Rapid Antigen Detection Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures. The Pinnacle Cov-ID RAD Rapid Antigen Detection Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.