- The emergency use authorization (EUA) specifies that to be used at home, the test must be prescribed by a healthcare provider first.
- It’s also authorized for use in point-of-care (POC) settings, like doctor’s offices, hospitals, urgent care centers, and emergency rooms, according to an FDA press release.
- The test is made by Lucira Health and is the result of 5 years of research, according to the company’s website.
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On Tuesday, the Food and Drug Administration (FDA) approved a new, rapid at-home COVID-19 test.
The
It’s also authorized for use in point-of-care (POC) settings, like doctor’s offices, hospitals, urgent care centers, and emergency rooms, according to an FDA
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic,” FDA Commissioner Dr. Stephen M. Hahn said in a
It’s made by Lucira Health and is the result of 5 years of research, according to the company’s website.
But you can’t just request one. To get a prescription, your doctor will have to suspect you’ve contracted SARS-CoV-2, the virus that causes COVID-19.
“This test will allow individuals to test themselves at home with what the company claims is a 94 percent sensitivity and 98 percent specificity,” Jeremy M. Levin, DPhil, chairperson of BIO and CEO of OVID Therapeutics, Inc., told Healthline.
Levin further explained that in medical diagnosis, test sensitivity is the “ability of a test to correctly identify those with the disease,” which is the true positive rate, “whereas test specificity is the ability of the test to correctly identify those without the disease.”
According to Levin, testing is critical to controlling the pandemic, “not just to identify those infected, but to enable them to be isolated, and where appropriate, cleared to work with others.”
When asked if people should be trusted to self-administer an at-home COVID test, Levin responded, “Yes, if it’s simple enough. After all, we test blood for diabetes [at home], but it’s essential they report the results and take action.”
He added that testing would also need to be combined with coordination of the results into a “central data repository, to allow national monitoring.”
According to the
- Antigen tests. These detect specific proteins from the virus and are faster — but have a greater chance of missing active infection.
- Molecular testing. These tests, which
RT-PCR tests, can detect genetic material specific to the SARS-CoV-2 virus. They have a significantly reduced risk of false negative results.
The FDA has authorized nearly 300 tests for the virus, reported the Associated Press (AP), but most require the nasal swab be performed by a health professional and sent to laboratories.
According to the AP, only a few of those tests allow people to collect their own sample at home for shipment to a lab, and it usually means a delay of several days to find out the results.
According to Lucira Health, their all-in-one at-home diagnostic kit is a molecular test with analytical sensitivity, “or ability to detect the SARS-CoV-2 virus,” comparable to some of the best molecular tests “performed in clinical settings and high complexity labs.”
With the Lucira test, users swab themselves to collect a nasal sample. The sample is then mixed in a vial of laboratory solution, which is plugged into a portable device. The results are shown with lights labeled “positive” or “negative.”
Critically, the new test, unlike previous RT-PCR tests, can provide results in about a half hour. This may even change how states respond to the latest infection surge sweeping the country.
“If the test has been properly developed — then, yes, this can be very, very, helpful in terms of providing guidance and helping us to do viral surveillance as quickly as possible,” said Dr. Matthew Heinz, a hospital physician in Tucson, Arizona. “Because we are in the midst of this terrible, urgent pandemic once more.”
According to Heinz, “We are basically swabbing almost every person admitted to the hospital.” One of the biggest delays he deals with is getting people properly roomed while he and other staff wait for the results.
“[This] can take anywhere from 3 to 5 hours to give us some kind of indication as to their COVID status,” he said. “The cue to getting us through this is to really make sure that we have the most robust viral surveillance.”
With new restrictions coming into effect nationwide, we’re all concerned about when we’ll be able to shop or go to school as we did before the pandemic. The new at-home test might help get us there sooner.
According to Dr. Nikhil Bhayani, an infectious disease physician with Texas Health Resources, “This will help reduce the public burden of disease transmission, therefore in the long-run could help with keeping businesses and schools open.”
However, Bhayani cautioned that, as with any rapid tests, “there could be false negative tests in those people who have clinical symptoms of COVID-19.”
Heinz insisted that only the most robust and consistent viral surveillance can ensure that, when we have pockets of outbreaks, resources can be properly marshaled and directed so that regions don’t have to be entirely shut down.
“That literally helps us to save lives, and it gets us back to, not normal — because we may never completely get there — but it gets us back to as normal as we can get things, for the moment, as possible,” he concluded.
The FDA has issued an EUA for a new, rapid at-home COVID-19 test to be prescribed to patients suspected of contracting the novel coronavirus.
However, it can only be self-administered by individuals ages 14 years or older. Younger patients must have a nasal swab administered by a healthcare provider.
It can be used either at home or in a medical setting and provides results in about 30 minutes.
Experts say the new test, while not perfect, could play a role in keeping businesses and schools open during the pandemic.
Experts add that the new test will need to be combined with coordination of the results into a central data repository to allow for national monitoring.