LumiraDx SARS-CoV-2 Ag Test

Description

• Features: High-sensitivity, microfluidic immunofluorescence assay for direct and qualitative detection of nucleocapsid proteins in nasal swab specimens from patients suspected of COVID-19 with Results in 12 minutes Uses nasal samples to detect nucleocapsid protein antigen with 97.6 % positive agreement to an EUA approved RT-PCR method within the first 12 days of symptom onset For use with the LumiraDx instrument Includes: 48 LumiraDx test strips 48 extraction buffer vials 48 dropper lids LumiraDx SARS-CoV-2 Ag test quick reference instructions Notes: Test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C
• §263a, that meet requirements to perform moderate, high or waived complexity tests 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 Authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens USA only- test is authorized for duration of declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes 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 authorization is terminated or revoked sooner