Positive or invalid results are returned to the customer by phone or by a healthcare provider. Users will be notified by email or portal online if the results are negative.
“While many home storage kits can be suggested with a simple question naline questionnaire, this new authentic direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA said the kit could help individuals understand their Covid-19 status and make decisions when needed for self-isolation or quarantine. It can also help with healthcare decisions after discussing with providers.
After purchasing the test, users register the kit on the website and follow the instructions included.
“Test results are delivered securely to the customer via Pixel through the Labcorp portal.” “The healthcare provider will advise customers who test positive to assist in healthcare treatment and actions.”
The company stressed in its news release that the new Covid-19 AT-Home test kit is not an option for a doctor’s visit.
First home Covid-19 prescription test
The FDA said the rapid test uses molecular amplification technology to detect the virus in people with known or suspected Kovid-19 and could return results within 30 minutes, the FDA said.
A molecular covid-19 test detects signs of the genetic material of the coronavirus.
There are currently two types of diagnostic tests: molecular tests, such as RT-PCR tests, that detect the genetic material of the virus; And antigen tests that detect specific proteins from viruses.
At the EUA time for the Lucira test, FDA Commissioner Dr. Stephen Hahn called it a critical development.
“This new testing option is an important diagnostic progression to eliminate the epidemic and reduce the public burden of disease transmission,” Hahn said.
Health and Human Services Secretary Alex Azare also said testing was an important step forward at the time.
“Making it possible for Americans to perform their own rapid COVID-19 auto-test by prescription at home is the latest addition to our ever-expanding arsenal of COVID-19 testing options,” Azar said in a statement.
But some health experts urged caution.
“The data is still emerging,” Tom Bolecki, director of the World Health Program and senior partner for the development of global health, economics and the Council on Foreign Relations, told CNN. It pays to be cautious, but it’s definitely a promising sign. “
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