Focus Taiwan
Date: 06/05/2020
By: Chang Ming-hsuan and Elizabeth Hsu

Taipei, June 5 (CNA) The Food and Drug Administration (FDA) has approved a domestically-developed and produced antibody reagent for the COVID-19 coronavirus disease, the first of its kind licensed in Taiwan, an FDA official said Friday.

The license for mass production was issued last week after the antibody reagent passed clinical testing, evaluation and verification, Wang Chao-yi (王兆儀), a research fellow in the FDA's medical equipment division, told CNA.

It is the first domestic antibody reagent for COVID-19 to be licensed in the nation, Wang said, noting that it takes only 10-15 minutes for the reagent to produce results after blood is taken.

The reagent has been proved to be 90 percent accurate at coronavirus antibody testing, she added.
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