Abbott Laboratories announced on Wednesday that it will ship one million coronavirus antibody blood tests this week.
The Illinois-based global health care leader is the first to market with this test that many medical experts say is a key element of a plan to reopen the country while a coronavirus vaccine is under development.
“Abbott is significantly scaling up its manufacturing for antibody testing and is expecting to immediately ship close to 1 million tests this week to U.S. customers, and will ship a total of 4 million tests in total for April. The company is ramping up to 20 million tests in the U.S. in June and beyond as it expands the tests to run on its new Alinity™ i system,” Abbott said in its statement.
“Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines,” the statement noted.
The company described the test as “a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19).”
“We continue to contribute in a significant and meaningful way by providing new solutions across our diagnostics testing platforms. I’m extremely proud of the many Abbott people who are working around the clock to get as many tests as we can to healthcare workers and patients,” Robert B. Ford, president and chief executive officer of Abbot, said in the statement.
The company’s statement provided this additional information about the new test:
While molecular testing detects whether someone has the virus, antibody tests determine if someone was previously infected.
Abbott’s SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered. Abbott’s IgG antibody test will initially be available on its ARCHITECT® i1000SR and i2000SR laboratory instruments*. More than 2,000 of these instruments are in use in U.S. laboratories. These instruments can run up to 100-200 tests per hour.
Abbott is making the test available as part of the U.S. Food and Drug Administration (FDA) notification without an Emergency Use Authorization (EUA) pathway outlined in Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Additionally, Abbott plans to file an EUA submission with the FDA and plans to CE Mark to the IVD Directive (98/79/EC) in the European Union.
Today’s announcement marks the launch of the third COVID-19 test to be produced by Abbott since the start of the coronavirus pandemic.
In March the company launched a quick test that can determine in five to 13 minutes if someone has COVID-19, as Breitbart News reported.