STATUS™ COVID-19/Flu A&B Rapid Antigen Test

Status™ COVID-19/Flu A&B

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-CoV-2, influenza A and/or 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.

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 product 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.

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  • Each Box Contains:

  • 25 individually packed test strips the test strips contain mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV

  • 25 Extraction Reagent capsules

  • 25 individually packed sterile Swabs

  • 1 Positive Control Swab: Influenza A, B, and SARS-CoV-2 antigen

  • 1 Negative Control Swab

  • 1 Package Insert /Instructions for use

  • 1 Quick Reference Instructions

Specification:

  • Sample Type: nasopharyngeal swab specimens

  • Detection Method: Colloidal Gold

  • Detection Time: 15 minutes

  • COVID-19 – Anterior Nasal – Sensitivity 93.8%,  Specificity 100%
    Nasopharyngeal – Sensitivity 93.1%,    Specificity 100%
    • Flu A – Sensitivity 91.4%,  Specificity 95.7%
    • Flu B – Sensitivity 87.6%,  Specificity 95.9%

  • Interim order: IO#326827

  • All necessary reagents provided and no equipment is needed

Delivery Guy
  • In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;

  • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,

  • 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19