Understanding the ImmunoCardTM
A green tab means you have adequate neutralizing antibodies present (>30%)
A red tab means you do not have adequate neutralizing antibodies present (<30%)
- 1This defines the percentage of neutralizing antibodies that you have specific to the SARS-CoV-2 virus. A positive result is defined as > 30%.1
- 2This section defines when you should get a retest as defined by the parameters established in the FDA EUA approval. The app will notify you when a retest is suggested.
- 3This defines the percentage of neutralizing antibodies that you have specific to the Delta Variant. A positive result is defined as > 30%.2
- 4A positive N1 test indicates the presence of detectable antibodies to N1 and suggests a past infection with the SARS-CoV-2 virus in this individual. A negative N1 test suggests that a recent infection with the SARS-CoV-2 virus in this individual has not occurred.3
1The neutralizing antibody test has been authorized by the FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist for justifying the authorization of emergency use 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. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
2The semi-quantitative and Delta neutralizing antibody components of the test have been modified under CLIA guidelines to report total blocking activity percentages (%), quantification of blocking antibodies in IU/ml, anti-Delta variant neutralizing antibody blocking activity percentages (%), automation, and finger stick specimens.
3This N1 fragment antibody test was developed, and its performance characteristics determined, by Healix Pathology, LLP laboratory (CLIA# 06D2174124). It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA and is qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.