FDA Approves Covid Home Test Kit

The FDA has announced approval in the US of the first at-home Covid test and it provides rapid results.

The test is available with a prescription, and can be used at home with nasal swabs for those aged 14 and older whose doctor suspects they might be infected with Covid-19, and will cost around $50.


“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 Stephen Hahn said in a statement.


Able to produce results in 30 minutes or less, the Lucira All-in-One has proven 100 percent efficacy with a rich enough sample, and a 94-98 percent positive-negative diagnosis accuracy with a limited sample.


Testing up until now has been done at a clinic, which can deter people due to the perceived risk of contracting the virus there, and even afterward the sample would have to be carefully handled, labeled, and tracked as it’s sent to a lab for analysis.


Those under 14 years of age will still need to have the test administered by a medical care professional. “Now, more Americans who may have Covid-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, the FDA’s boss at the Center for Devices and Radiological Health.