On Tuesday, the Food and Drug Administration allowed emergency use of the first at-home coronavirus test that can provide results in 30 minutes.
Dr. Anthony Fauci, the nation’s top infectious disease expert, said on CNN Thursday night that he thinks the test is just a “first step,” and he’d like to see the development of a test that doesn’t require a prescription. Additionally, Lucira Health, the California-based company that developed the test, noted it “has not been evaluated” in asymptomatic people.
Here’s what we know so far about the test.
How does it work?
The test kit allows users to swirl a swab in both nostrils, then dip the sample in a vial of solution. That vial is then plugged into a device that will light up as “positive” or “negative” within 30 minutes.
The FDA notes that those taking the test should report their results to their health care providers, who are then required to inform public health officials who track the spread of the virus.
It requires a prescription from a health care provider, and children under the age of 14 can’t perform the test on themselves.
The test uses a method called a loop-mediated isothermal amplification reaction, or LAMP, which works by copying the virus’s genetic material until there are detectable levels. That allows the test to identify the virus even when there are low levels of it.
How much does it cost?
It will cost $50, Lucira said in a statement.
When will it be available?
It is likely to be available “in the near future” for at-home use to patients served by two clinics, one in northern California and one in Miami, Fla., the company said. Lucira said it is expected to be available nationally through health care providers by early spring 2021.
How effective is it?
Lucira said the test was able to detect 94.1 percent of infections that were found by a polymerase chain reaction, or PCR, test, which is thought to be the most accurate way to detect the virus, and the test correctly identified 98 percent of the uninfected people.
The small study Lucira conducted only included people who had symptoms of COVID-19.
Is there anything else like it?
The FDA has approved other tests that people can administer at home, but they then have to be sent to a lab to process, which can take days.
Material from the Associated Press was used in this report.