Roche's First At-Home Rapid Antigen Self-Test for SARS-CoV-2 Receives FDA EUA

Roche announced last Friday that it has received FDA EUA authorization for at-home COVID-19 testing, to expand the availability of rapid self-testing in the United States.

This reagent, the first rapid antigen test for SARS-CoV-2 authorized by Roche, will be available for purchase over-the-counter at U.S. pharmacies and retailers starting in January 2021.

COVID-19 Home Self-Test Kit is a rapid chromatographic immunoassay qualitative test capable of detecting SARS-CoV-2 nucleocapsid protein in anterior nasal swab specimens.. Results can be obtained within 20 minutes, capable of detecting coronavirus including Omicron.

Samples can be self-collected and self-tested by individuals aged 14 and above, and children aged 2 to 13 can have samples self-collected and self-tested by an adult.

This reagent is intended for use within six days prior to the onset of coronavirus infection, or when there is suspicion of COVID-19 infection with or without symptoms or other epidemiological reasons. In the latter intended use, the individual must undergo two tests within three days, with a testing interval of at least 24 hours and no more than 48 hours.

According to clinical research data, Roche's COVID-19 self-test product has a relative sensitivity of 95.3% and a relative specificity of 100%.

At the same time, it collaborated with SD Biosensor, a South Korean company, signing a global distribution agreement and jointly launching multiple reagents approved by CE between 2020 and 2021.

Roche said that the partner's ability to provide a large number of tests and expand production to meet future demand has led the FDA to prioritize authorization, and added,It has the capacity to produce tens of millions of reagents every month.To help support the pandemic response.

The company will provide information on COVID-19.Digital applications,The program is called Navify Pass, which allows individuals and healthcare professionals to store, query, and share results after taking a COVID-19 home test. All tests will provide a unique data matrix, enabling Navify Pass to automatically link personal test results to their testing device.

What certifications has Roche obtained in the U.S. for its COVID-19 products?