Another Victory! Biotest Biotech COVID-19 antigen home test obtained the FDA EUA!

2022-12-28


Recently, Advin COVID-19 Antigen Test @Home, a self-test for the SARS-CoV-2 antigen developed by Advin, a US-held subsidiary of Biotest, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) after laboratory validation and clinical research evaluation showed that it met relevant standards. 



The test is suitable for over-the-counter (OTC) testing at home and in other non-laboratory settings. It has the advantages of simple operation and convenient interpretation which only takes 10 minutes to get the test results. Access to the FDA EUA means that the product can be sold in the United States and countries and regions that recognize the EUA certification.

Previous to this, Biotest Biotech SARS-CoV-2 antigen tests have been registered/certified in many countries and regions, including Germany, France, Italy, Switzerland, Czech Republic, Brazil, Australia, Canada, Thailand, Hong Kong, etc. In addition, the SARS-CoV-2 antigen test reagents produced by Biotest Biotech have passed the evaluation and certification of the University of Oxford in the UK, and have also been listed in the European Union's HSC Common List. Moreover, the SARS-CoV-2 antigen saliva test has obtained the CE self-testing certification. Biotest Biotech SARS-CoV-2 antigen tests have been unanimously recognized by agencies and users with excellent performance and quality. The approval of the EUA has further enhanced the international competitiveness of the company's COVID-19 testing products, and laid a solid foundation for the steady development of COVID-19 testing business in the era of normalized epidemic prevention and control.

About Biotest Biotech


Established in 2008, Hangzhou Biotest Biotech Co., Ltd. is a national high-tech enterprise which mainly develops and produces rapid diagnostic reagents. The company's leading products include infectious disease testing, drug abuse testing, tumor marker testing, cardiac marker testing and women health testing series, which are widely used in hospitals at all levels, CDC, blood stations, drug rehabilitation center and third-party testing institutions. Biotest Biotech focuses on independent research and development of products and technology accumulation, and has a highly innovative and pioneering R & D team, which provides company with a number of patented technologies and innovative products every year. Relying on strong R & D and technological innovation capabilities, Biotest is at the forefront in the research of colloidal gold, latex, fluorescence labeling technology, single/polyclonal antibody, gene recombinant antigen, synthetic antigen and other biological raw materials technology, as well as immunochromatography technology and other cutting-edge biological fields.


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