(CNN) — The US Food and Drug Administration has granted an emergency use authorization for the first over-the-counter, non-prescription covid-19 test kit for home use.
The LabCorp Pixel COVID-19 Home Test Collection Kit allows anyone over 18 to purchase the kit and collect nasal swab samples at home, the FDA said in a press release Wednesday. The samples are then sent to a LabCorp facility for analysis.
Positive or invalid results are reported to the client by phone or through a healthcare provider. Users will be notified by email or through an online portal if the results are negative.
“While many home collection kits can be prescribed with a simple online questionnaire, this newly licensed direct-to-consumer collection kit eliminates that step in the process, allowing anyone to collect their sample and send it to the lab for testing. processing, ”said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
This is how the over-the-counter covid-19 test works
The kit can help people understand their COVID-19 status and make decisions about when self-isolation or quarantine may be necessary, the FDA said. You can also help with health care decisions after talking with providers.
“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities,” said Dr. Brian Caveney, medical director and president of LabCorp Diagnostics, in a statement.
The new kit is now available through the Pixel by LabCorp website and will soon be available in stores, the company said in a press release.
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After purchasing the trial, users register the kit on the website and follow the included instructions.
“Test results are delivered securely to the consumer through the Pixel by LabCorp portal,” said LabCorp. “A health care provider will counsel consumers with positive results to help with treatment and health care actions.”
The company emphasized in its press release that the new covid-19 home test kit is not a substitute for visiting the doctor.
First test at home with medical order of covid-19
Last month, the FDA issued an EUA for the first covid-19 self-test that can provide rapid results at home, but the Lucira COVID-19 All-In-One Test Kit, a single-use molecular test, only it is available by prescription.
The rapid test uses molecular amplification technology to detect the virus in people with known or suspected COVID-19 and can return results in 30 minutes, the FDA said.
A molecular test for covid-19 looks for signs of the genetic material of the coronavirus.
There are currently two types of diagnostic tests: molecular tests, such as RT-PCR tests, which look for the genetic material of the virus; and antigen tests that detect virus-specific proteins.
At the time, FDA Commissioner Dr. Stephen Hahn called the Lucira test a critical development.
“This new testing option is an important diagnostic advance in addressing the pandemic and reducing the public burden of disease transmission,” Hahn said.
Health and Human Services Secretary Alex Azar also said at the time that the test was an important advance.
“Being able to do a rapid COVID-19 self-test at home with a prescription is the latest addition to our ever-expanding arsenal of testing options,” Azar said in a statement.
But some health experts urged caution.
“The data is still emerging,” Tom Bollyky, director of the global health program and a senior fellow for global health, economics and development at the Council on Foreign Relations, told CNN. “Obviously, with some previous emergency use authorizations, it’s worth being careful what the FDA has posted here, but it’s certainly a promising sign.”
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