After developing a high-throughput assay and a rapid point-of-care test, Abbott is now launching its third COVID-19 diagnostic, focused on detecting a person’s antibodies to the novel coronavirus.
The blood test is designed to be run in a centralized laboratory using the company’s Architect analyzer hardware, which Abbott says is already in use at about 2,000 U.S. facilities and can provide between 100 and 200 results per hour. The devicemaker also plans to expand the test’s use to its newer line of Alinity instruments.
Serology tests such as these can be used to provide a deeper understanding of the virus’s spread, and can tell whether a person has previously had the disease.
This could also help gauge how long protective antibodies last within the body following an infection, according to Abbott. The test specifically identifies the common bloodstream antibody immunoglobulin G, or IgG; Abbott plans to add laboratory testing for the antibody IgM in the future.
The company plans to distribute 4 million tests in the next two weeks as it ramps up production to 20 million tests per month beginning in June for both the Architect and Alinity systems.
The test is being made available first without an official FDA authorization, after the agency relaxed its policies for antibody tests. Abbott says it plans to file full applications for emergency use as well as for European CE mark approval.
Abbott previously received an FDA green light for its ID NOW rapid test consisting of a small, tabletop box capable of scanning swab samples for the novel coronavirus’s molecular signature and providing a result in less than 20 minutes.