The Trump administration on Aug. 27 announced that it has struck a deal to purchase 150 million new rapid COVID-19 tests to be distributed across the United States.
The $760 million deal with U.S. healthcare company Abbott Laboratories was granted emergency use authorization (pdf) by the Food and Drug Administration the day prior, Aug. 26.
The “BinaxNOW COVID-19 Ag Card” test (pdf) offers results in 15 minutes and will sell for only $5, according to Abbott. It is also highly portable—about the size of a credit card—and does not require any special machine to analyze the results. The company praised the test as “a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale.”
The test could be used at point-of-care settings such as a doctor’s office, emergency rooms, and potentially some schools.
White House Press Secretary Kayleigh McEnany said the announcement marks “a major development that will help save more lives by further protecting America’s most vulnerable and allow our country to remain open, get Americans back to work, and get kids back to school.”
🚨 President @realDonaldTrump has announced the purchase and production of 150 million rapid tests.
This is a major development that will help our country to remain open, get Americans back to work, and kids back to school!
— Kayleigh McEnany (@PressSec) August 27, 2020
Department of Health and Human Services (HHS) Secretary Alex Azar said in a statement, “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.”
He added that the testing would potentially be “deployed to schools and to assist with serving other special needs populations.”
The White House noted that final production will be scaled to “an unprecedented 50 million tests monthly.” Abbott said in a statement that it was preparing to “ship tens of millions of tests in September, ramping production to 50 million tests a month in October.”
The latest effort comes as part of Operation Warp Speed, the administration’s initiative to quickly develop safe and effective vaccines and therapeutics to combat the CCP virus.
This is the fourth rapid test designed to detect COVID-19 antigens, which are proteins on the virus’s surface.
Two other developers of antigen tests, Quidel and Becton Dickinson, said they have not been able to meet demand for the tests. LumiraDx, another developer, is planning to ship its antigen tests by the end of August.
How it Works
The test involves a nasal swab and a test card with a strip that can detect the virus.
“A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card,” the FDA announced of the latest test system.
The results can be read directly from the testing card, just like some pregnancy tests, the agency said. “One line indicates a negative result; two lines indicate a positive result.”
“This test has been authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset,” the agency noted, which means that it is not authorized for those who are asymptomatic or presymptomatic.
The FDA noted, however, that results from antigen tests in general are less reliable compared to molecular tests that take longer to return the results.
“In general, antigen tests are very specific, but are not as sensitive as molecular tests,” the FDA announced, noting that the test could return false negative results—where a person tests negative when they are actually infected.
The BinaxNOW test is 97.1 percent sensitive, which means it correctly diagnoses people who have the CCP virus 97.1 percent of the time. It is 98.5 percent specific, which means that it correctly rules out the disease in 98.5 percent of healthy people. The company says these figures make the test reliable.
“Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the FDA stated. “Negative results from an antigen test should be considered in the context of clinical observations, patient history, and epidemiological information.”