First Covid tests that give immediate result to user at home authorised in US

The US Food and Drug Administration (FDA) has approved the first self-testing Covid-19 diagnostic kit that can deliver results within minutes at home.  

Emergency approval was granted for the single-use All-In-One Test Kit made by Lucira Health on Tuesday.  

The rapid testing kit uses nucleic acid amplification technology, considered more accurate than antigen tests. 

"In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2,” the agency said.

It can be used on anyone aged 14 or older who is suspected of having Covid-19, and works simply by swirling the nasal swab in a vial that is then placed in the test unit.

The test is authorised only for prescription use at the moment. Apart from home use, the product is also authorised to be used in hospitals and at doctor’s clinics.  

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen M Hahn said.  

While some Covid-19 testing kits allow people to test themselves at home and send off a swab to a laboratory, Mr Hahn underscored that this is the first solution that can be fully administered and return results at home. The FDA was committed to expanding Covid-19 testing in the US, he said. 

The news comes with virus cases surging across what is already the worst-hit country in the world. The US has recorded another 158,254 new cases in the last 24-hour period, adding to a tally of more than 11 million confirmed cases. There have been almost 250,000 deaths related to Covid-19 in the country.  

The spike in cases has mounted the pressure on healthcare services in the country with reports of full hospitals and exhausted health care workers struggling to cope.