Abbott (NYSE:ABT) this week received FDA emergency use authorization (EUA) for its AdviseDx SARS-CoV-2 IgG II diagnostic — providing another tool to detect people’s adaptive immune response to COVID-19.
The serology test from Abbott Park, Ill.-based Abbott is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 — the virus causing COVID-19 — in human serum and plasma.
An FDA letter notifying Abbott of the EUA said the indication includes collections using a serum separator tube for the human serum samples and acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin for the plasma samples.
Abbott’s test is intended for identifying an adaptive immune response to SARS-CoV-2 to indicate recent or prior infection, and samples should only be tested from individuals who are 15 days or more post symptom onset. Use of the test is limited to authorized laboratories.
Samples for the test must be analyzed using the Abbott Architect i1000SR, Abbott Architect i2000SR or the Abbott Alinity i system.
Authorization for the IgG antibody assay comes after Abbott in October received EUA for its IgM antibody serology test for COVID-19. The AdviseDx SARS-CoV-2 IgM lab-based serology test runs on the Architect and Alinity platforms, too.