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September 30, 2020

Abbott Labs' rapid COVID-19 tests begin to ship worldwide

Workers in neon vests and hardhats swarm over construction in a huge warehouse Photo / Tim Greenway Landry/French workers renovate Abbott Laboratories' new Westbrook site in July. The plant was fitted out so the company could produce a new low-cost rapid COVID-19 test, which began to ship this week. The company said it can produce 50 million of the tests a month at the plant.

Abbott Laboratories (NYSE: ABT) began shipping out its new COVID-19 rapid tests this week, as both the U.S. government and World Health Organization have ordered the low-cost test.

The White House Monday announced that 150 million of the $5 tests would be shipped in the coming weeks, many to nursing homes and assisted living communities and other populations vulnerable to spread of the coronavirus. The World Health Organization, through a partnership with the Bill & Melinda Gates Foundation, has also ordered 120 million tests from Abbott and South Korea-based SD Biosensor to be shipped to low-income countries over the next six months.

The Food and Drug Administration in late August approved emergency use authorization for the tests, which are the size of a credit card and take 15 minutes to produce results. Chicago-based Abbott has said the Westbrook production plant, which opened in July, will produce 50 million tests a month by October. The company's Maine headquarters are in Scarborough.

Access to tests has been cited since the pandemic began in March as key to slowing its spread. To put the need for testing into perspective, Peter Sands, head of the Global Fund, told WHO Monday that while the order for tests is a "massive increase," it's just a fraction of what's needed worldwide. Sands said the target countries will go through the 120 million tests in less than two weeks, AP reported.

The Global Fund is providing $50 million of the $600 million cost of the WHO/Gates Foundation order.

The test comes with a phone app that allows those tested to display their results when asked by organizations where people gather, such as workplaces and schools. The test has demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study, according to Abbott.

Sensitivity means that it can identify someone who has been exposed to the virus and developed antibodies. Specificity means that it can rule out someone as having virus antibodies.

How rapid testing works

Abbott's BinaxNOW COVID-19 Ag Card is an antigen test, which means it detects proteins — antigens — on the outside of the virus and are best at detection when people are at the height of infection, health experts say. The approach is similar to that of a pregnancy test, and sampling can be done with a shallow nasal swab. The other kinds of tests, PCR (polymerase chain reaction), works by picking up minuscule amounts of the virus and must be analyzed in a laboratory.

Because antigen tests aren't as sensitive as other tests, the FDA approved them to be used only to confirm the coronavirus in people showing symptoms. But the Trump administration is deploying the tests more widely to screen asymptomatic people in nursing homes, on Indian reservations, at historically black colleges and in public schools — and told health officials to disregard the FDA policy, the Washington Post reported Tuesday.

Abbott has launched seven COVID-19 tests in the U.S. since the beginning of the pandemic, ranging from the new BinaxNOW to lab-based molecular and antibody tests. The company has provided more than 27 million tests to all 50 states since the pandemic began. 

In late August, Abbott announced it is hiring 1,200 employees, 300 permanent, for its new manufacturing plant at 5 Bradley Drive in Westbrook. The company already employs 800 in Scarborough. The Westbrook site was leased in the spring and fitted out to manufacture the new tests, beginning production in July.

Abbott has 107,000 employees in 160 countries. It produces a range of health care technology, and has businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. It had sales of $31.9 billion last year.

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