This test is authorized to be performed and marketed by the FDA. This testing service is based on a newly released test system from Abbott and will be run on Abott's ARCHITECT i1000SR and i2000SR laboratory instruments. These instruments can run up to 100-200 tests an hour.
Abbott first made this test available as part of the US FDA notification process without an Emergency Use Authorization pathway outlined in “Policy for Diagnostic Test for Coronavirus Disease – 2019 during the Public Health Emergency – Immediately in Effect Guidance for Clinical Laboratories, commercial manufacturers, and Food and Drug Administration Staff” issued on March 16th, 2020. The FDA acknowledged the marketing and distribution of this new antibody serology test on April 13th, 2020. Abbott was granted FDA Emergency Use Authorization (EUA) on April 26th, 2020.
The accuracy of a lab test is measured in "sensitivity" and "specificity". Sensitivity is the test's ability to correctly identify those with antibodies (true positives) and specificity is the test's ability to identify those without the antibodies (true negatives). According to independent studies from Abbott Labs, Quest Diagnostics and the University of Washington, this test has a sensitivity of 100% and a specificity of 99.6% making it the most accurate COVID-19 antibody test currently available.