Respiratory Test Kit Status COVID-19 / Flu A and B 25 Tests CLIA Waived (M-1186780)

Name: TEST KIT, RAPID SARS COV-2/FLUA&B ANTIGEN (25TESTS/KT) • 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 • 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 • Product ships with minimum 60 days dating • 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 nasopharyngeal swab for superior specimen collection and patient comfort • COVID-19 - Sensitivity 93.9%, Specificity 100% • Flu A - Sensitivity 91.4%, Specificity 95.7% • Flu B - Sensitivity 87.6%, Specificity 95.9% • 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 • No Analyzer/Reader required