COVID-19 IgG/IgM Rapid Antibody Test
This test is used to detect COVID-19 antibodies. A positive antibody test result suggests the patient was recently infected by COVID-19 or has developed an immune response through vaccination.
Results are generally reported within 30 minutes at most locations.
- FDA issued this guidance to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers during the public health emergency. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform waived, moderate or high complexity test;
- 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. The sensitivity of the EcoTest COVID-19 IgG/IgM Rapid Test Device early after infection is unknown. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status;
- 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.
Assure COVID-19 IgG/IgM Rapid Test Device
- IgG: This is the most common antibody. It’s in blood and other body fluids, and protects against bacterial and viral infections. IgG can take time to form after an infection or immunization.
- IgM: Found mainly in blood and lymph fluid, this is the first antibody the body makes when it fights a new infection.