CORONAVIRUS/Taiwan approves 1st domestic COVID-19 antibody reagent
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.
Wang said the antibody reagent will help researchers determine how many people have been infected by the novel coronavirus in a bid to better understand the real extent of infection in Taiwan during the pandemic.
The licensed reagent, mainly used at laboratories as a supplementary testing kit, can help with efforts to shed light on community outbreaks, Wang added.
According to the FDA, it has so far approved the import of 19 testing reagents for COVID-19 and the mass production of three reagents for nucleic acid testing since the coronavirus outbreak emerged in China late last year.
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