Wednesday, September 28, 2022

FDA authorizes first COVID-19 home testing kit

home testing kit

As the pandemic continues to spread, some countries are hitting new records of Covid-19 cases per day while others go back into total lockdown. Although it may seem like the pandemic is winning, humanity is scoring its own wins. Starting from the two proposed Covid-19 vaccines, to the latest innovation in home testing kits. 

Earlier this week the FDA authorized the first Covid-19 home testing kit after issuing an Emergency Use Authorization (EUA) for the kit. The kit gives results within 30 minutes and in the comfort of your own home. 

Lucira Health, an American biotechnology company based in Emeryville, CA, launched the Lucira COVID-19 All-in-One Test Kit that includes instructions and materials needed for people to conduct the test themselves. 

People will need to collect their own nasal swab sample then proceed to swirl it in an included sample vial. The vial is then placed into a battery-powered test unit device that will ultimately display an LED light indicating if the result is positive or negative, it can even indicate if the test was inconclusive. 

The Lucria home testing kit is single-use and requires a prescription; it is intended for home use among individuals age 14 or above with suspected Covid-19 or with serious symptoms. In an announcement, Lucira Health said they anticipate the kit will cost roughly $50 and will initially have limited availability. 

The platform has been in development for about half a decade, initially as a flu diagnostic. Lucria Health then shifted their direction to Covid-19 as the pandemic broke out earlier this year. The company also plans on updating their EUA or filling out a new one by Q2 2021, to allow online consultation and overnight delivery.