AssureTech EcoTest COVID-19 Antibody Test IgM/IgG Rapid Test Kit (Box of 20)
You must agree this item is NOT for resale and must provide your NPI or CLIA number to purchase this test and that this test is being used for surveillance purposes only as described by the FDA. This product is for professional purchase only and a CLIA License or NPI emailed to firstname.lastname@example.org will be required by your organization to complete this order.
AssureTech's EcoTest COVID-19 IgG/IgM Rapid Test Device is an in-vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma.
EcoTest has been validated by the FDA and found to have a 100% Sensitivity for IgM (30/30) and 98.8% Specificity for IgM (79/80). IgG Sensitivity was 90% (27/30) and Specificity was 100% (80/80).
EcoTest is one of only a small number of COVID-19 rapid antibody tests that have both FDA Emergency Use Authorization and that detect two types of antibodies (IgM and IgG) - IgM peaks early in the disease and IgG peaks later during the illness. This combination provides broader capture of patients exposed to COVID-19.
AssureTech's EcoTest performance was validated by a US physician researcher and several of the box contents were enhanced as a result. There is no other COVID Rapid Antibody test like it on the market. EcoTest is for professional use only.
Features & Benefits
- Results in 15 minutes
- Easy to use and read
- Tests for both IgM and IgG antibodies
- Individually packaged kits for one time use
- Validated against RT-PCR results
- This test has been authorized by FDA under an EUA for professional use.
- This test has not been FDA cleared or approved.
- This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. Ãƒâ€šÃ‚Â§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This product is intended for professional use and not for home use.
- This product is not for the screening of donated blood