LumiraDx SARS-CoV-2 Ag Test

Microfluidic immunofluorescence assay for direct and qualitative detection of nucleocapsid proteins in nasal swab specimens

Supplier:  LumiraDx L016000109048

Catalog No. 22-181-001

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

Specifications

• Control Sets: Available separately
• Detectable Analytes: SARS-CoV-2 Nucleocapsid Protein Antigen
• For Use With (Application): Microfluidic Immunofluorescence
• Quantity: 48 Test Strips/Pk.

• Clia Complexity: Waived
• Type: Rapid Test
• For Use With (Equipment): LumiraDx Instrument
• Test Time: 12 min.

Authorized under EUA for use by authorized labs, test has not been FDA cleared or approved