Positive or false results are delivered to the consumer over the phone or through a healthcare provider. Users will be notified by email or online portal if the results are negative.
“Although many home collection tools can be recommended with a simple online questionnaire, the newly approved Direct-Consumer Collection Kit eliminates that step from that process, allowing anyone to collect their sample and send it to the processing lab,” Dr. Jeff Shuren, director of the FDA’s Center for Equipment and Radiation Health, said in a statement.
This kit will help individuals understand their Covit-19 status and make decisions about when self-isolation or isolation may be needed, according to the FDA. It may also help with health decisions after discussions with providers.
After purchasing the test, users should register on the Kit website and follow the instructions on it.
“The test results are safely delivered to consumers via Pixel through the Lapcorp portal,” Lapcorp said. “A healthcare provider will advise consumers who test positive to help with health care and actions.”
The company stressed in its press release that the new Covid-19 at-home testing kit is no substitute for a doctor’s visit.
First home Covid-19 drug test
Rapid testing uses a molecular multiplication technology to detect the virus in those with known or suspected Covit-19, and the FDA says it will give results within 30 minutes.
A molecule Covit-19 test looks for signs of the genetic material of the corona virus.
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 to detect specific proteins from the virus.
During the EU test for Lucira, FDA Commissioner Dr. Stephen Hahn said this was a significant development.
“This new testing option is an important diagnostic breakthrough to address the epidemic and reduce the general burden of spreading the disease,” Han said.
Health and Human Services Secretary Alex Azhar said the test was a significant improvement at this time.
“Enabling Americans to recommend their own rapid COVID-19 self-testing at home is a recent addition to the ever-expanding arsenal of COVID-19 testing options,” Azhar said in a statement.
But some health experts insisted with caution.
“Data is still coming out,” said Tom Poliki, director of the World Health Organization and senior member of the Foreign Health Council’s Global Health, Economy and Development CNN. “Obviously, with the last few emergency application approvals, it pays to be wary of what the FDA has published here, but it’s definitely a promising sign.”