The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Phase Scientific International’s INDICAID COVID-19 Rapid Antigen At-Home Test (INDICAID OTC).
The test obtained authorisation for non-prescription, at-home use.
Now that it is available across the US, people in the country will be able to perform the test on-demand.
INDICAID is a lateral flow immunoassay that has been designed for the detection of SARS-CoV-2 antigens from anterior nasal swab specimens collected from individuals with or without Covid-19 symptoms.
The samples may be self-collected by individuals aged 14 years and above. Adults can collect samples from individuals aged two years and above.
The Covid-19 rapid antigen at-home test takes 20 minutes to complete.
It showed strong performance, with accuracy in identifying 85% of Covid-19 positive people (PPA) and 97% of those negative (NPA) for the virus from self-collected samples in a prospective multi-site clinical study conducted in the US.
Phase Scientific founder and CEO Dr Ricky Chiu said: “The professional version of INDICAID has been widely adopted and utilised in the US to meet a variety of emergency testing needs. From schools, mobile testing sites, urgent care networks and hospitals.
“We see the approval of INDICAID OTC for non-prescription home testing to expand the adoption of our product to everyone’s daily life and further support our fight against the pandemic.”
In July 2020, the company obtained CE Mark approval for its PHASIFY Viral RNA extraction kit.
Following this approval, Phase Scientific expanded the commercialisation of its test kits to the European Union and other countries as part of the fight against Covid-19.