Antigen Detection Control Swab Kit Status™ COVID-19 / Flu A and B Positive Level / Negative Level 10 Swabs

Features

• Status™ COVID-19 / FLU A and B test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Control Swabs for use with 1186780 (33225) Kit Contains: Positive Control Swab (5): Influenza A
• B
• and SARS-CoV-2 antigen (non-infective recombinant nucleocapsid protein) and Negative Control Swab (5): Inactivated Group B Streptococcus antigen (non-infective) Status™ COVID-19/Flu test is a lateral flow immunoassay intended for the in vitro rapid
• simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2
• influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals
• who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider
• within the first five days of onset of symptoms Results are for the simultaneous identification of nucleocapsid antigens of SARS-CoV-2
• influenza A and influenza B
• but does not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens Positive results indicate the presence of viral antigens
• but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status Positive results do not rule out bacterial infection or co-infection with other viruses Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities Negative SARS-CoV-2 results should be treated as presumptive and confirmed with a molecular assay
• if necessary
• for patient management 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 The Status™ COVID-19/Flu test is intended for use by medical professionals and laboratory personnel trained to perform the test Flocked swabs for superior specimen collection and patient comfort During the duration of the emergency this test can be performed in a patient care setting that is operating under a CUA Waiver
• Certificate of Compliance or Certificate of Accreditation