The Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV2, influenza A and influenza B directly from anterior nasal or 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. Test results are interpreted at 15 minutes.

Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

• Test type: Lateral flow immunoassay
• Specimen type: Anterior nasal or nasopharyngeal swab specimens
• Turnaround time: 15-20 minutes
• Certification: FDA Emergency Use Authorization (EUA)
• CLIA complexity: Waived
• COVID-19 Sensitivity: 93.1%, Specificity 100%
• Flu A Sensitivity: 91.4%, Specificity 95.7%
• Flu B Sensitivity: 87.6%, Specificity 95.9%

• Product Brochure
• Product Insert
• Instructions for Use
  
• Fact Sheet for Patients
• Fact Sheet for Healthcare Providers

The Status™ Covid-19/Flu A&B test has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point-of-Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only for the detection of proteins from SARS-CoV-2 influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. 

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