The COVID-19 antigen test kit produced by Xiamen-based AmonMed Biotechnology. [Photo/WeChat account: touzixiamen]

On March 18, the COVID-19 antigen test kit produced by Xiamen-based AmonMed Biotechnology became the first in Fujian province to be approved by the National Medical Products Administration (NMPA) for self-testing at home.

Since March 2021, the company's COVID-19 Antigen Rapid Test Kit (Colloidal Gold) has passed the National Institutes of Food and Drug Control's examination, obtained the European Union's CE certification and the emergency authorization from the German Federal Agency for Medicines and Medical Devices (BfArM) for home use, and has been added to the EU's HSC common list. The product has also completed clinical tests and registration in more than 20 countries in Europe, Southeast Asia and South America.

Before the approval by the national authority, AmonMed Biotechnology's test kits were mainly exported to Germany, Spain, Czech, Malaysia, Thailand and Singapore. After the approval, the company has spared two workshops, especially for domestic market supply.

In addition to AmonMed Biotechnology, Xiamen currently has companies including Biotime, Boson Biotech, Anbio, BioDetect and Merlin Biomedical that produce COVID-19 test kits.

Test kits from these companies are mainly exported to European and Asian countries. Due to the different test kit standards in domestic and overseas markets, these companies are still waiting for the NMPA's approval.

Xiamen's medicine administration said that it will continue to offer support to these companies and help more test kit products receive approval. Meanwhile, it will also strengthen market monitoring to ensure people's safety when using the products.