AccessBio "COVID-19 Antigen Home Test Receives US FDA Emergency Use Authorization"

[Asia Economy Reporter Hyunseok Yoo] Access Bio announced on the 4th that it has received Emergency Use Authorization (EUA) from the US FDA for its COVID-19 antigen self-test kit.

The approved product is the CareStartTM COVID-19 Antigen Home Test. With this approval, Access Bio's product can be purchased anywhere online or offline without a prescription.

The CareStartTM COVID-19 Antigen Home Test allows for quick and easy detection of infection within 10 to 15 minutes by collecting a specimen from the nasal cavity using a swab. Anyone aged 14 or older can use it alone, and children under 14 can be tested with the assistance of an adult.

A company representative stated, “According to the CDC, currently 49.7% of the US population has completed vaccination, but despite the faster vaccination rate compared to other countries, confirmed cases are rapidly increasing again due to various variants such as Delta. This can be interpreted as indicating that COVID-19 testing remains important to prevent the spread of infection, and the usefulness of COVID-19 self-test kits that can be easily purchased without a prescription is expected to be high.”

Meanwhile, in clinical trials conducted for Emergency Use Authorization, Access Bio's product recorded a sensitivity of 87% and a specificity of 98%.

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