China’s national medical product regulator has granted market approval to two antigen test kits that can detect COVID-19 and provide results within 20 minutes.
Developed by two biotech companies in Guangzhou and Beijing respectively, these products are the country’s first approved antigen test kits for COVID-19, the National Medical Products Administration said in a statement on Thursday.
The testing tools can quickly detect positive cases when the viral load is high during the acute infection period. They can be used for early triage and rapid management of suspected patients.
As a supplement to current COVID-19 detection methods, antigen testing cannot be used alone to identify infection but should be combined with nucleic acid tests, imaging and other diagnostic information to determine the infection status, according to the statement.
It noted that further nucleic acid testing is needed for both positive and negative antigen results in suspected COVID-19 cases.
Apart from the two antigen test kits, China has so far approved 24 COVID-19 nucleic acid detection reagents and 25 antibody detection reagents.