Hefei companies apply for domestic COVID-19 antigen testing registration certificates

A few days ago, the government decided to add antigen test as a supplement to nucleic acid detection.At present, there were 12 antigen detection reagents have been approved for the market. A number of enterprises in Hefei High-tech Zone are actively applying for domestic COVID-19 antigen testing registration certificates.

In June 2020, a company in Hefei developed the COVID-19 antigen test, which has been certified by the European Union CE,Australia TGA and other countries, and its products are exported to many overseas countries. "The product is highly sensitive and specific and can also detect mutated strains." Wang Li, head of the company, said that antigen detection can be used as a supplementary means of screening COVID-19, which is conducive to the early detection of viruses.

When a patient has symptoms of a cold or fever, or is quarantined at home, self-examination can be conducted to find out if the infection happens or not and whether isolation measures need to be taken, preventing cross-infection in a more timely and effective manner.

Compared with nucleic acid test, antigen test kit is similar to pregnancy test stick, which can be done at home, without needing a professional equipment, getting results within 15 minutes. It’s convenient and efficient.

According to the reagent instructions, the nasal swab after sample collection was immediately placed in the sample tube, and the liquid was rotated and mixed with the preservation solution by squeezing the outer wall of the sample tube, and finally the liquid was dropped into the sample hole of the test card. After a few minutes, you can view the test results. If both "C" and "T" show a red band, it is positive, and if "C" shows a red band, it is negative, Wang said.

Wang also told reporters that she had submitted materials to the State Food and Drug Administration in early March and was applying for a registration certificate. Other companies have also submitted relevant materials. "Our product is an independent innovation,using antibodies developed and produced by ourselves. In the process of research and development, we have received financial support from the Provincial Development and Reform Commission." Once the registration certificate is approved, production capacity will be increased to ensure the stability of the supply chain.