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2022


12.21

FDA EUA for ImmuView® COVID-19 Ag Home Test is here!FDA EUA for ImmuView® COVID-19 Ag Home Test is here!

The U.S. FDA has granted Emergency Use Authorization for CTK Biotech’s ImmuView® COVID-19 Antigen Home Test

On December 20th, CTK Biotech obtained the FDA’s Emergency Use Authorization for their ImmuView® COVID-19 Antigen Home Test, a few months after being the first to receive the WHO Emergency Use Listing for their international brand, OnSite® COVID-19 Ag Self Test. The FDA EUA qualification allows greater accessibility of ImmuView® Home Test across the U.S. for individuals, families, and businesses to perform COVID-19 testing at home or on the go.

The ImmuView® COVID-19 Antigen Home Test is an easy-to-use nasal swab test that is intended to aid in the rapid detection of SARS-CoV-2 (the virus that causes COVID-19) and provide quick results in under 15 minutes. This test is authorized for non-prescription home use with self-collected samples from individuals aged 14 years, and older or adults collected samples from individuals aged 2 years to 13 years. This test is expected to be available for distribution by the end of January 2023. CTK Biotech has the production capacity to manufacture tens of millions of COVID-19 Antigen Home Tests per month to meet market demands.

The product met the high threshold requirements of the U.S. FDA, with a sensitivity of 89.6% (95%CI: 77.8%-95.5%) and a specificity of 98.8% (95%CI: 95.8%-99.7%), compared to a highly sensitive nucleic acid (RT-PCR) detection method. This product has been rigorously evaluated in a layperson study fully conducted in the U.S., thereby covering current circulating variants of concern.

 

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