InBios receives FDA EUA for home use antigen test for COVID-19

Nov. 30, 2021

As the demand for fast, reliable self-tests for COVID-19 antigen remains high, InBios International Inc., a developer of diagnostic tests for emerging infectious diseases, announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) allowing the company to market its SCoV-2 Ag Detect Rapid Self-Test, a three-step home use antigen test for COVID-19 that provides results in ~20 minutes.

The nasal swab test, designed to be extremely simple to use for consumers who are not familiar with self-testing, will soon be available for purchase without a prescription in major retail stores and online through e-commerce channels. It may be used for self-testing by individuals 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old. The test can be useful in a number of scenarios, helping an individual determine in three easy steps if they are safe to go to work, attend school or simply carry on with daily interactions with others.

The SCoV-2 Ag Detect Rapid Self-Test kit features the same SARS-CoV-2 rapid antigen test that received an EUA from the FDA for use in professional settings in May 2021. The test, which can be purchased in single test or multi-pack configurations, features a unique ease-of-use patent-pending design and uses shallow nasal swabs with no instrumentation required to read results. It is designed for use with symptomatic and asymptomatic serial testing.

The clinical performance of the SCoV-2 Ag Detect Rapid Self-Test, a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen, was evaluated in a simulated home environment study in the U.S. The study showed that the test accurately determined 85.71% of those who were positive (PPA) and 100% of those who were negative (NPA) for SARS-CoV-2 antigen for nasal swab samples collected from symptomatic patients within 5 days post symptom onset (PSO).

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