Home COVID-19 test gets FDA approval

The first COVID-19 test that can be carried out at home has now been approved by the Food and Drug Administration (FDA) for consumers in the US.

The test will be available on a prescription-only basis for home use and will allow people to check if they are infected with the virus. The test is manufactured by Californian company Lucira Health and has been approved under emergency FDA authorization rules. 

According to the FDA, the test will be a self-collected nasal swab. Specimens will be able to be taken in anyone over the age of 14 that has a suspected case of COVID-19. 

Consumers will need a prescription from a healthcare provider to get a test. Alternatively, the test is authorized for point of care use in various healthcare settings. 

“CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, with self-collected nasal swab specimens in individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC.”

How does it work?

The FDA says the test uses molecular amplification technology to detect SARS-CoV-2 RNA in suspected cases, which means anyone with symptoms or individuals that have had contact with a confirmed or suspected case of the virus. 

After self-collecting a swab sample, the test is placed in a test unit. The results can be read within 30 minutes, and will show a simple positive or negative in a display window. The company’s website lists the cost of a test at under $50.  

In cases of positive results, the person will need to seek medical care and to self-isolate for a period of time. Additionally, anyone with a negative test that has concerns over symptoms will be advised to seek further medical advice. 

Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement that this should simplify tracking and testing and, hopefully, reduce new cases. 

He said, “A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. 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.”