LumiraDx SARS-CoV-2 Surveillance Test

Description

• Description The LumiraDx SARS-CoV-2 Antigen (Ag) Surveillance Tests are used with the LumiraDx Instrument for COVID-19 surveillance testing
• With lab-comparable results in 12 minutes, the LumiraDx SARS-CoV-2 Ag Surveillance Test delivers fast, accurate, cost-efficient pooled testing onsite to verify that COVID-19 isn’t spreading in your population or quickly implement preventative measures when clusters emerge
• For Surveillance use only* 100.0% positive agreement and 96.6% negative agreement with LumiraDx SARS-CoV-2 Ag Test Up to 5 specimens on a single Test Strip Pooled swab sample may be applied to a single test strip, without sacrificing sensitivity Results in 12 minutes Orders require executed contractual agreement
• Please contact your Fisher Healthcare Account Representative for more information *Surveillance Testing is intended to monitor community - or population - level outbreaks of disease, or to characterize the incidence and prevalence of disease
• It is performed on de-identified specimens, and thus, results are not linked to individual people
• The LumiraDx SARS-CoV-2 Ag Surveillance Test has not been cleared, approved, or authorized by FDA
• 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.