China has approved eleven COVID-19 antigen self-test kits to enhance its early detection amid the recent rise of COVID-19 confirmed cases and asymptomatic infections.
On March 11, China National Medical Products Administration (NMPA) allowed Beijing Savant Biotechnology's COVID-19 antigen test kit for self-testing. In the following three days, NMPA gave marketing approval to another ten domestically-made test kits.
11 Companies with COVID-19 Antigen Self-test Kits Approved in China by March 14 | ||
No. | Company | Approval Date |
1 | Beijing Savant Biotechnology Co., Ltd. | March 11, 20221 |
2 | Nanjing Vazyme Biotech Co., Ltd. | March 12, 20222 |
3 | Beijing Jinwofu Bioengineering Technology Co., Ltd. | |
4 | Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. | |
5 | Guangzhou Wondfo Biotech Co., Ltd. | |
6 | Beijing Wantai BioPharm Co., Ltd. | March 13. 20223 |
7 | Beijing Hotgen Biotech Co., Ltd. | |
8 | Tianjin Bioscience Co., Ltd. | |
9 | Chongqing Mingdao Jiece Biotechnology Co., Ltd. | |
10 | Beijing Lepu Diagnostic Technology Co., Ltd. | |
11 | Beijing Beier Bioengineering Co., Ltd. | March 14, 20224 |
According to National Health Commission (NHC), the self-test kits are permitted to be sold at drug retailers and online pharmacies.5 By March 14, some pharmacies have started selling the kits on online shopping platforms, including Tmall, Meituan, and JD.com. For example, Alibaba Health sells Vazyme's COVID-19 self-test kits on Tmall at 486 yuan for 20 units in one box, meaning that one test costs about 24.3 yuan (3.82 USD).
Currently, COVID-19 antigen self-test kits appear to be a niche in the market because self-tests can be easily and rapidly conducted at home and show test results in a short time. Also, the need for COVID-19 tests is growing, as the daily new domestically-transmitted cases soared high from 26 on Feb. 136 to 1,337 on March 137.
The need for COVID-19 antigen self-test kits surges amid the current round of outbreaks. For example, Jilin provincial government has ordered 12 million8 kits as the province recently saw the highest number of new cases across China.
Under such circumstances, COVID-19 antigen self-tests would help reduce the burden of medical institutions overwhelmed with nucleic tests. Self-tests are complementary to nucleic acid tests, while the latter are more accurate. But nucleic acid tests cost a longer time and can only be conducted in a limited number of medical institutions. Given the two kinds of tests' pros and cons, China regards nucleic acid test results as evidence for diagnosing COVID-19 infection and antigen self-tests as a tool for early detection.
China has developed a robust supply chain for producing COVID-19 antigen self-test kits. The country exported kits worth more than 66.89 billion9 overseas last year. Now as China has opened its domestic kit market, the competition between relevant suppliers will be highly fierce.
Though the domestic market is emerging for COVID-19 antigen self-test kits, the market outlook still depends on national and provincial measures. The long-term use of self-test kits requires disease control authorities to provide an information platform for people to report self-test results. Also, provinces differ in their needs for the kits as they face different numbers of new cases. These factors should be considered by investors and companies before they enter the market.
