Celltrion's Covid self-test kit gets FDA emergency approval

[Source: Celltrion Inc.]

Celltrion’s self-diagnostic kit for Covid-19 has received emergency use authorization from the U.S. Food and Drug Administration, the South Korean biopharmaceutical company said on Monday. Its ‘DiaTrust COVID-19 Ag Home Test’, co-developed by local healthcare firm Humasis, received the Emergency Use Authorization approval based on a clinical trial of 490 subjects with or without Covid-19 symptoms, where the kit showed 86.7 percent and 99.8 percent accuracy in sensitivity and specificity, respectively.

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