COVID-19 Rapid Antibody Test

The Assure COVID-19 IgG/IgM Rapid Test Device, a test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 (often referred to as COVID-19 or the novel coronavirus) in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood.

The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity

September 23, 2020 and the FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” issued on March 16, 2020 (updated May 11, 2020). The

• 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.