Rapid Response™ Liberty COVID-19 IgG/IgM Rapid Diagnostic Test EUA CLIA Waived (USA)

Product Description

Authorized for use at the Point of Care (POC)

The Rapid Response™ Liberty COVID-19 IgG/IgM is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA) and fingerstick whole blood. The Rapid Response™ Liberty COVID-19 IgG/IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Rapid Response™ Liberty COVID-19 IgG/IgM should not be used to diagnose or exclude acute SARS-CoV-2 infection.

Testing of serum, plasma and venous whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform high or moderate complexity tests.

Testing of fingerstick whole blood specimens 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 high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens 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.

Clinical Performance

Product Documentation

• Fact Sheet for Healthcare Providers
• Fact Sheet for Recipients
• FDA EUA Letter
• Instructions for Use
• Quick Reference Instructions

Authorized Laboratories

Testing of serum, plasma and venous whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform high or moderate complexity tests.

Testing of fingerstick whole blood specimens 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 high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens 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.

Safety Information

• For use under Emergency Use Authorization only
• For in vitro diagnostic use only
• For prescription use only
• CLIA complexity: WAIVED, MODERATE and HIGH

Disclaimers

• This test has not been FDA cleared or approved.
• This test has been authorized by FDA under an EUA for use by authorized laboratories.
• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• Authorized laboratories must use your product as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
• Authorized laboratories that receive your product must notify the relevant public health authorities of their intent to run your product prior to initiating testing.

For information on the EUA, IFU, and purchase orders please contact your local sales representative or contact us at sales@btnx.com or 1-888-339-9964.