Carolina Liquid Chemistries is now offering the Point-of-Care (POC)/Waived, FDA Emergency Use Authorized Status™ COVID-19/Flu AB Antigen Rapid Test from Princeton BioMeditech Corp. / LifeSign

Product Description

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. Test results are interpreted at 15 minutes.

Use of this test is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the the requirements to perform high or moderate complexity tests or waived 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.

Kit includes

  • Status COVID-19/Flu test devices (25): The test strip in each device contains mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV-2. The device is individually pouched.

  • Extraction Reagent in capsules (25): For use with swab specimens; 300 μL of Phosphate buffer with detergents and preservative

  • Sterile Swabs (25): For swab specimen collection

  • Positive Control Swab (1): Influenza A, B, and SARS-CoV-2 antigen (non-infective recombinant nucleocapsid protein)

  • Negative Control Swab (1): Inactivated Group B Streptococcus antigen (non-infective)

  • Package Insert /Instructions for use (1)

  • Quick Reference Instruction (1)