AccessBio, COVID-19 Self-Test Kit Receives US FDA Emergency Use Authorization

by Seo Sojeong

Published 04 Aug.2021 16:21(KST)

[Image source=AP Yonhap News]

[Asia Economy Reporter Seo So-jeong] Access Bio announced on the 4th that it has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 antigen self-test kit (CareStart COVID-19 Antigen Home Test).

Accordingly, Access Bio products can now be purchased online and offline in the U.S. without a prescription.

By using the Access Bio COVID-19 self-test kit, a sample can be collected from the nasal cavity with a swab to confirm infection status within 10 to 15 minutes. Individuals aged 14 and older can use it alone, while children under 14 can be tested with the assistance of an adult.

An Access Bio official stated, "COVID-19 diagnosis is important to prevent the spread of infection, and the usefulness of self-diagnostic kits that can be easily purchased without a prescription is expected to be high," adding, "We plan to sell the self-test products for regular use in schools and companies."

In clinical performance trials conducted to obtain Emergency Use Authorization, the product showed a sensitivity of 87% and a specificity of 98%.

Previously, OTC (over-the-counter) products authorized for emergency use by the U.S. FDA include OraSure, Abbott, Quidel, and Ellume.