The New Crown Antigen Self-Testing Products Were Approved For Marketing Who Can Self-Test?

On March 12, the State Drug Administration (SDA) issued a notice approving the application changes for self-testing applications of new coronary antigen products from Nanjing Novozymes, Beijing Jinwoof, Shenzhen Huada Innogen, Guangzhou Wanfu Bio and Beijing Huaketai Bio. Since then five new crown antigen self-test products have been officially listed.

　　Previously, the National Health and Wellness Commission issued a notice stating that it had decided to add antigen testing as a supplement to nucleic acid testing and organised the development of the "Application Scheme for New Coronavirus Antigen Testing (for Trial Implementation)".

　　Who can self-test? Can self-test results replace nucleic acid results? Can it be used as proof of travel? Where can I buy self-testing reagents?

　　1. Who can self-test?

　　The Programme for the Application of New Coronavirus Antigen Testing specifies that three categories of people can self-test.

　　 (i) People who visit primary health care facilities with respiratory and fever symptoms and who have had symptoms for less than 5 days.

　　 (ii) Persons under isolation and observation, including those under home isolation and observation, close and sub-close contact, inbound isolation and observation, and those in closed control areas and control zones.

　　 (iii) Community residents who have a need for antigen self-testing.

　　2. Can self-test results replace nucleic acid results?

　　No. Nucleic acid testing is still the basis for confirming the diagnosis of neocoronavirus infection.

　　The "Basic requirements and procedures for self-testing for neo-coronavirus antigens" in the pilot programme emphasises that antigen testing is generally used for samples taken during the acute infection period, i.e. within 7 days of the onset of symptoms in the suspected population.

Both positive and negative antigen results in the suspected population should be subjected to further nucleic acid testing.

Positive results can be used for early triage and rapid management of the suspected population, but cannot be used as a basis for confirming the diagnosis of neo-coronavirus infection.

　　3. Where can I buy self-testing reagents?

　　The programme states that community residents who have a need for self-testing can purchase their own antigen testing reagents for self-testing through retail pharmacies, online sales platforms and other channels.

　　The management department organising isolation and observation (e.g. community, village, town, isolation site, etc.) is responsible for the purchase, distribution and management of antigen testing reagents and other related work.

　　It is important to note that in order to ensure the quality of sampling and testing, residents must read the instructions carefully and follow the prescribed requirements and procedures to carry out sampling, spiking and result interpretation in a standardised manner.