COVID-19 antigen tests get overseas approval

Updated: 2021-09-22

A COVID-19 antigen detection kit developed by Hotgen Biotech Co was certified on Sept 21 by the Medicine and Healthcare products Regulatory Agency (MHRA), Britain's drug regulator. This means the product has access to the British market for home monitoring.

Hotgen Biotech Co, a bio-pharmaceutical enterprise, is a high-tech company in Beijing's Daxing district. 

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The MHRA granted market approval to a COVID-19 antigen detection kit developed by Hotgen Biotech Co on Sept 21. [Photo provided by Daxing district]

The kits are able to detect the Delta strain first documented in India, the Alpha strain first reported in the UK, the Beta strain first found in South Africa and many other variants of the COVID-19 virus.

It is easy to use and works quickly, which will make it a powerful new aid for pandemic prevention and control in the UK.

Previously, this product obtained the German BfArM certification, the European Union CE certification, and the clinical verification of Brazil and the UK supported by the Global Foundation for Innovative Diagnostics.

The kit is now on the market in many countries, including Germany, France and Italy.