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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


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Description

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

Specifications

Available separately
Nucleocapsid Proteins
Microfluidic Immunofluorescence
48 Test Strips/Pk.
Waived
Rapid Test
LumiraDx Instrument
12 min.
SDS
Documents

Documents

Product Certifications
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Promotions

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