NEW YORK – The US Food and Drug Administration on Monday granted Emergency Use Authorization to Abbott Laboratories for the company's AdviseDx SARS-CoV-2 IgG II test.
The chemiluminescent microparticle immunoassay is intended for the qualitative and semi-quantitative detection of SARS-CoV-2 IgG antibodies in human serum and plasma using Abbott's Architect and Alinity immunoanalyzers, including the Architect i1000SR, the Architect i2000SR, and the Alinity i system. Abbott's first SARS-CoV-2 IgG antibody test received EUA last April.
The test is intended to help identify patients with an adaptive immune response to SARS-CoV-2 that indicates a recent or prior infection. The samples should only be tested from people at least 15 days out from symptom onset and use of the test is limited to moderate- and high-complexity labs.
To run the two-step test, the sample, SARS-CoV-2 antigen coated paramagnetic microparticles, and assay diluent are combined, incubated, and washed, the FDA said in its letter of authorization. Anti-human IgG acridinium-labeled conjugate is added, followed by pre-trigger and trigger solutions, and the resulting reaction is measured as a relative light unit. The amount of IgG antibodies in the sample correlates to the relative light unit detected, FDA added. The test requires other materials like authorized calibrators and a control kit that aren't included with the kit but are available from Abbott.
Abbott's AdviseDx SARS-CoV-2 IgM serology test received EUA from the FDA in October.