Testing Strategies for COVID-19
There are a range of testing strategies for COVID-19: Diagnostic, Screening and Surveillance. Further information on each type of strategy including their intended use and applications, regulatory requirements, and reporting requirements can be found here
COVID-19 Tests available from LumiraDx
LumiraDx SARS-CoV-2 Ag Surveillance Test
Up to five swabs in one test.
Monitor prevalence of the virus in your population.
For surveillance testing only, not for diagnostic use
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.FIND OUT MORE
LumiraDx SARS-CoV-2 Ag Test
- Authorized for individuals suspected of COVID-19 within 12 days of symptom onset
- 97.6% positive agreement and 96.6% negative agreement with RT-PCR
- Authorized for screening asymptomatic individuals using a single test
- Results in 12 minutes
LumiraDx SARS-CoV-2 Ag Test has not been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. The test has not been authorized for use to detect any other viruses or pathogens. The test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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.
Supporting healthier lives, for individuals, communities and wider society
Enabling responsive, personal relationships between patients and care teams.
Controlling and reducing costs to help ease pressure on healthcare budgets.