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

More Information

• Status COVID-19 / Flu A and B Test FDA EUA Letter
• Status COVID-19 / Flu A and B Test IFU
• Status COVID-19 / Flu A and B Test Healthcare Providers Fact Sheet
• Status COVID-19 / Flu A and B Test Patients Fact Sheet
• Status COVID-19 / Flu A and B Test Sell Sheet