Status™ COVID-19/Flu A&B Antigen Test (FDA Emergency Use Authorization Granted)

Point-of-Care Antigen Test for SARS-CoV-2, Influenza Type A, and Influenza Type B. To place orders and set up an account, call 877-722-8910.

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

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Product Brochure

Instructions for Use

Fact Sheet for Healthcare Providers

Fact Sheet for Patients

Emergency Use Authorization Letter from the FDA

Procedure Card

Safety Data Sheet

FDA Guidance – Policy for Diagnostic Tests for COVID-19 during the Public Health Emergency

FDA EUA Viral Mutation Revision

Emergency Use Test Purchase Agreement

New Customer Setup Form

Product Description

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 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.

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, moderate, or waived complexity. 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)

Important Information

The Status COVID-19/Flu A&B Antigen test from Princeton BioMeditech Corp. has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories operating minimally with a CLIA Certificate of Waiver. This test 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. This test 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.