Monday, 10 May 2021

Taiwan's first domestic COVID-19 Ab reagent gets FDA approval

05 June 2020 | News

The reagent produces the test results in less than 15 minutes with 90 per cent accuracy

image courtesy: freepik

image courtesy: freepik

Taiwan on 5 June 2020 licenced it's first domestically-developed and produced antibody reagent for SARS-CoV-2 detection. 

The reagent passed clinical testing, evaluation and verification to receive FDA approval for mass production. The reagent produces the test results in less than 15minutes with 90 per cent accuracy. 

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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