Test sensitivity is 98.6% and specificity is 96.3%
Our IgG test results are reported quantitatively over 5 orders of magnitude. You can be positive for COVID-19 IgG from .6 micrograms/mL all the way up to 1,250 micrograms/mL. Granger believes that just reporting a “positive” is not good enough, so we tell you exactly how high your IgG antibody levels are, because you and your healthcare provider need to know.
Test was FDA Allowed on May 2, 2020.
(NOTE: There is a difference between Allowance and Approval. Test kit manufacturers must apply for FDA Approval. Granger Genetics is not a test kit manufacturer. Laboratories like Granger Genetics who are CLIA-accredited to perform complex testing do not apply for FDA approval of their tests. However, labs may voluntarily submit formal “Notice” to the FDA containing all their test validation data, and after the FDA accepts the Notice, the test is referred to as “Allowed”. Granger Genetics’ COVID-19 Antibody Tests are FDA Allowed.)
Our Neutralizing Antibody Test is currently in validation. When we have received FDA Allowance on that test it will be offered to the public.