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Test Name
Visual Read
Test Type
Nasal Swab / Nasopharyngeal Swab Sample
Time to Results
Test Strip Format
UNSPSC Code
Rapid Microfluidic Immunofluorescence Assay
SARS-CoV-2 Ag Surveillance Test
Surveillance Test
12 Minute Results
41116205
Features
The LumiraDx SARS-CoV-2 Ag Surveillance Test is a rapid microfluidic immunofluorescence assay for the direct and qualitative detection of nucleocapsid protein antigen in nasal and nasopharyngeal specimens allowing a pooled testing approach of up to 5 specimens
This test should be used for surveillance purposes (i.e.
to inform population or community-level decision-making on de-identified specimens) only; FDA does not regulate surveillance tests
The SARS-CoV-2 Ag Surveillance Test is for surveillance purposes only and not for use in diagnostic procedures
Up to 5 specimens may be pooled and added to a single test strip
without sacrificing sensitivity
The LumiraDx SARS-CoV-2 Ag Surveillance Test has not been cleared
approved
or authorized by FDA
Lab-comparable results in 12-minutes
The LumiraDx SARS-CoV-2 Ag Surveillance Test delivers fast
accurate
cost-efficient pooled surveillance testing onsite
The LumiraDx SARS-CoV-2 Ag Surveillance Test is intended for use by individuals proficient in performing tests using the LumiraDx Instrument
100.0% positive agreement and 96.6% negative agreement with the LumiraDx SARS-CoV-2 Ag Test
LumiraDx Instrument is required but not provided
