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Law360 (August 28, 2020, 8:47 PM EDT) -- The Trump administration has inked a $760 million contract with Abbott Laboratories for enough rapid-response COVID-19 tests to screen nearly half of the country, only days after the test kits received emergency approval from the U.S. Food and Drug Administration.
The tests cost about $5 apiece and should return results within 15 minutes, according to the government.
"By strategically distributing 150 million of these tests to where they're needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations," U.S. Department of Health and Human Services Secretary Alex Azar said in a statement Thursday.
But exactly where, when and how the tests will be dispatched remains unclear. The agency's statement noted that "testing will be potentially deployed to schools and to assist with serving other special needs populations." It provided no further details on those populations.
The announcement comes as the novel coronavirus continues to take a toll on the country, claiming the lives of more than 180,000 people in the United States alone. More than 5.9 million people have tested positive for the respiratory illness, which attacks and damages the lungs, even in cases where patients appear asymptomatic.
Testing has been a struggle in the United States, which lagged far behind its counterparts on the world stage when it came to the rollout of wide-scale screening for the virus. Crippling test shortages lasted well into the spring, and even as fall approaches, some areas are still struggling to turn tests around in a timely manner, with people reporting they waited weeks for their results.
Like most other COVID-19 tests, Abbott's rapid-response kits will work by testing a sample swabbed from the inside of a person's nose.
The test kits look like a small booklet without pages, with two small holes on the right inside cover and a strip for reading the results on the left. An extraction agent is dropped into one of the holes and the nasal swab is pushed through the other and swirled around.
After 15 minutes, the medical professional administering the test should be able to visually identify a positive or negative based on the pink or purple lines that appear on the test strip on the left side of the booklet, according to the FDA.
The FDA greenlighted the test for emergency use this week, allowing the product to hit the market before going through the formal agency approval process. Its approval comes with a warning: A negative test does not rule out coronavirus infection.
"Negative results should be considered in the context of a patient's recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19," the agency said after cautioning doctors not to rely on the tests to determine treatment.
Several federal laws give the FDA the power to grant emergency use authorization for certain untested — or not fully tested — products and medications, allowing them out onto the market early in case of an emergency. The agency has done this in the past for tests aimed at sussing out other forms of the coronavirus, such as Middle East respiratory syndrome, or MERS, and strains of the flu.
--Editing by Orlando Lorenzo.
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