Coronavirus test that gives results in minutes gets FDA approval. Here’s how it works
A new coronavirus test that can give results in minutes instead of hours just got approval from federal regulators, the U.S. Food & Drug Administration said Saturday.
The new test looks for COVID-19 antigens on samples collected through nasal swabs, according to the FDA.
State and federal health officials have been pushing for more testing and contact tracing to control the pandemic as states begin to loosen restrictions on businesses and travel.
Regulators granted emergency authorization Friday for the test, which is made by San Diego-based health care manufacturing company Quidel.
Public health officials have been relying on what are called PCR tests to look for genetic material from the virus.
“PCR tests can be incredibly accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes,” the FDA said in a news release Saturday.
But with added speed, there are issues with accuracy. The positive results from the test are “highly accurate,” the FDA said, but there are more false negative results. That means a negative test does not rule out an infection and someone would still need a PCR test.
“Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and once multiple manufacturers enter the market, can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time,” the FDA said Saturday.
A third type of test, serological tests, look for antibodies from the virus that can show if someone has already had the virus, according to the Centers for Disease Control and Prevention.
Douglas Bryant, chief executive of Quidel Corp., said the company’s workers “are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test.”
The new test system, he said, “allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient.”
This story was originally published May 9, 2020 at 4:24 PM with the headline "Coronavirus test that gives results in minutes gets FDA approval. Here’s how it works."
