Food and Drug Administration Permits Abbott’s TrialFor patients with COVID-19 on Wednesday, this is the first rapid coronavirus test that does not require any special computer equipment. The test is the size of a credit card and is based on the same technique used to test for flu, strep throat and other infections.
The FDA said in a statement announcing its decision, “Results can be read directly from the test card, a design similar to some pregnancy tests.” “This simple design is fast and efficient for healthcare providers and patients and does not require the use of an analyst.”
According to Abbott, this test will sell for only $ 5, giving it a competitive edge over similar tests that need to be run through the machine.
White House Strategic Communications Director Alyssa Farah said, “Under the leadership of President Trump, America is at the forefront of the world in trials. This is a major development that allows our country to stay open, get Americans back to work and get kids to school.” Will help. ” In a statement to CBS News. “The Trump administration is proud to partner with Abbott Laboratories to make this purchase possible to help the American people.”
Abbott’s new tests, however, still have limitations. Like most chronic coronovirus tests, rapid tests still require nasal inflammation by a health worker, and may be less accurate than slower tests. The FDA said in a statement announcing the ruling that negative results with Abbott’s test could be confirmed with laboratory testing in some cases.
According to the FDA, “In general, antigen tests are very specific, but not as sensitive as molecular tests.” “Because of the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test can be confirmed before making a treatment decision. Negative results from an antigen test must be considered in the context of clinical observations.” Patient history and epidemiological information. ”
Despite its limitations, the Trump administration’s agreement with Abbott could increase COVID-19 testing in the United States, a target of public health experts that the president rejected only months earlier.
During a campaign rally in June, Mr. Trump said, “When you’re testing to the extent that you’re going to find more people, you’re going to find cases. So I told my people, ‘ Slow down the test. ” Please.’ They test and they test. We got tests for people who don’t know what is going on. “Later Chairman, In protest against several White House officials who defended his remarks, claiming that they were made fun of.
The Center for Disease Control and Prevention revised its COVID-19 trial recommendations earlier this week, indicating that many people who have been exposed to coronovirus but are not showing symptoms, Is a concern for many medical experts because people who are asymptomatic can still spread the virus to others. The country’s top infectious disease specialist, Dr. Anthony Fauci said he was not weighed in the new guidance.
“I am concerned about the interpretation of these recommendations and I am concerned that it will touch misconceptions to people, which is a matter of great concern,” I said in an interview with CNN on Wednesday.
According to data collected by Johns Hopkins University, more than 5,800,000 cases of COVID-19 have been reported in the US and more than 180,000 deaths on Thursday.
Admiral Brett P. of the US Department of Health and Human Services (HHS). Giroir said on Wednesday that the agency does not expect new CDC guidance that test volumes in the US could be affected, adding that the government forecasts the volume will increase in the next few months as more people return to work and school and routine. Will be formally tested.
According to the FDA, Abbott’s test may be ideal for such testing. In its statement, declaring the authority, the FDA listed “point-of-care settings”, such as “doctor’s office, emergency room, or certain schools” as places where rapid testing is used. Can.
Abbott intended to ship “tens of millions” of tests the following month, then “did 50 million tests a month” in early October.
“Given the simple nature of this test,” the FDA wrote, “it is likely that these tests may be widely available.”
Finn Gomez contributed to this report.