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

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 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