Schools
COVID-19 Testing
According to CDC Guidelines, schools should monitor cases, identify clusters quickly, and promptly intervene to control spread.
When cases are introduced into the school environment, they can lead to clusters and potentially to rapid and uncontrolled spread. Viral testing strategies should be part of a comprehensive prevention approach to keep schools open.
CDC Guidance for COVID-19 Prevention in Schools
Click here to review the CDC guidelines and learn more
Testing provides an important layer of prevention, particularly in areas with substantial to high community transmission levels. Schools may consider testing a random sample of at least 10% of students who are not fully vaccinated or may conduct pooled testing for COVID-19.
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
Surveillance:
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.
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Diagnostic:
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 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests
- 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.
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