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Abbott antibody test cleared for emergency use

Staff Report //May 11, 2020//

Abbott antibody test cleared for emergency use

Staff Report //May 11, 2020//

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A fourth COVID-19 test from Abbott Laboratories, based in Illinois with a location in Liberty, received Emergency Use Authorization from the U.S. Food and Drug Administration, announced Monday.

This antibody test uses IgG antibodies found in the blood to detect whether patients have COVID-19 or have recovered from the virus. Despite the reputation for some antibody testing to result in false positives and negatives, the SARS-CoV-2 IgG serology test was 99.6% accurate in recent tests to exclude false positives and 100% accurate in its ability to exclude false negatives in patients tested 14 days after first showing symptoms of the virus, according to a news release.

"Having more options of highly reliable tests across our platforms will help health care workers and health officials as they conduct broad scale testing for COVID-19," Robert B. Ford, president and chief executive officer of Abbott, said in the release. "Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity."

The serology test will be used in critical-needs situations at hospitals and labs across the United States. Other Abbott antibody tests approved by the FDA for emergency use include its SARS_CoV-2 IgG antibody blood test using Architect laboratory systems and a test run via the lab’s  high-throughput Alinity i system, which is already in hospitals, academic centers and reference laboratories across the world, according to the release.

Abbott has made plans to ship 30 million antibody tests around the world this month, while bolstering capacity to distribute 60 million in June.

"Antibody testing has the potential to unlock a lot of unknowns about this novel virus," John Hackett of Abbot said in an earlier release. He is vice president of Abbot’s Division of Applied Research and Technology. "Having tests that can work in different health care settings is critical to our understanding of the virus and to helping give health care providers answers they need about their patients."

Initially awaiting FDA approval of a blood-based antibody test, the Piedmont-housed Blood Connection will offer free COVID-19 serologic testing for whole blood and plasma donors, according to today’s news release. The test does not confirm current infection or immunity but will help the blood bank determine whether donations can be processed for its ongoing convalescent plasma treatment in use at Prisma Health, Bon Secours St. Francis Health Care System and AnMed Health.

Appointments for blood or plasma donations can be made online.