FDA approves first rapid COVID-19 self-testing kit for at-home diagnosis
Hope is on the horizon, even as the U.S. joins its international counterparts in navigating a disturbing surge in novel coronavirus cases.
According to CNN, not only are vaccines from Pfizer and Moderna showing promise in early studies, but as of Wednesday, Nov. 18, the US Food and Drug Administration has issued an emergency use authorization for the first self-test for COVID-19 that can provide rapid results at home.
The Lucira COVID-19 All-In-One Test Kit is described as a molecular single-use test that can be purchased with a prescription for self-diagnosis of the coronavirus.
The rapid test uses a form of molecular amplification technology to identify the virus in patients suspected of being infected with COVID-19 and it can return results in 30 minutes, the FDA said.
"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home," FDA Commissioner Dr. Stephen Hahn said in a statement.
The new test, which uses self-collected nasal swab samples, is authorized for patients 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider.
According to the FDA, it's also approved for use in point-of-care settings, such as doctor's offices, hospitals, urgent care centers and emergency rooms for all ages but must be collected by a health care provider, the FDA said.
"This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," Hahn added.
CNN reports that Health and Human Services Secretary Alex Azar agreed.
"Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options," Azar said in a statement.
But some health experts urged caution.
"The data is just still emerging, Tom Bollyky, the director of the global health program and senior fellow for global health, economics, and development at the Council on Foreign Relations, told CNN. "Obviously with some past emergency use authorizations it pays to be cautious with what the FDA has put out here, but it's certainly a promising sign."
Health experts agree that the self COVID-19 home test may be one step closer to a country nearing a state of 'normality.'
"Expanded testing, rapid testing really could be one more tool that brings us back to a life that approaches more normalcy. If we're able to identify at least on, perhaps even a daily basis, what our current viral load is and it helps us make ourselves safer and others," he said.
The new self-testing kit includes a sterile swab, a sample vial, a test unit, batteries and a plastic disposal bag.
The sample collected on the nasal swab is inserted into the vial which then enters the test unit where it is analyzed. The results are displayed on the test unit by a color change in the LED indicators, according to the FDA. Instructions on how to use the test are included with the prescription.
This news comes on the heels of a Wednesday announcement from the US-based pharmaceutical company, Pfizer that its experimental COVID-19 vaccine is 95 percent effective in preventing the illness.
The company plans to seek FDA approval within days and if such approval is received, immediately begin shipping the potentially life-saving drug to patients who need it.
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