COVID-19 Rapid (15 min) Test | FDA Authorized (20 pk)
The Assure COVID-19 IgG/IgM Rapid Antibody Test is the first authorized by the FDA for emergency use (EUA) in POC settings.
This POC (CLIA-waived) usage means that testing samples do not need to be sent to a lab, and clear results are available within 15 minutes. Assuretech's Ecotest simultaneously tests for both early-stage (IgM) antibodies and the persistent, long-term (IgG) antibodies.
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- FDA authorized under an EUA (emergency use authorization).
- No special lab equipment required beyond the testing kit components.
Rapid on-site antibody screening with 98% accuracy.
- Fingerprick sample collection, no venipuncture required.
- Cost per test $17.49 (sold in pack of 20)
Assure Ecotest antibody testing kit boxes include:
- 20 individually wrapped testing kits that contain:
- Rapid test device
- Sanitizing alcohol wipe
- Bottle of buffer solution to accommodate all 20 tests
FDA Information Regarding Antibody Tests
The FDA wants to remind the public that antibody tests should not be used to diagnose an active infection, as they are designed to detect antibodies the immune system has developed in response to the virus – not the virus itself. The FDA Also reminds patients that it is unknown how long antibodies persist following infection and so results from these tests should not be seen as an indication that they can stop taking steps to protect themselves and others – such as social distancing, continuously wearing masks, or avoiding gatherings with anyone outside your immediate household.
According to FDA Commissioner Stephen Hahn, M.D., "These types of tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19."