[Explanation] At present, nucleic acid detection is still the basis for the diagnosis of new coronavirus infection, and antigen detection can be used as a supplementary method to screen specific groups of people, which is conducive to improving the ability of "early detection".
So far, the State Food and Drug Administration has approved 12 new coronavirus antigen detection reagent products.
On March 16, two manufacturers of novel coronavirus antigen detection reagents in Hefei, Anhui, are actively applying for a listing registration certificate in China.
[Concurrent] Wang Li, Deputy General Manager of Biohan Biotechnology (Hefei) Co., Ltd.
The National Joint Prevention and Control has also released a new testing plan, focusing on nucleic acid testing and adding new antigen testing.
Our company now has a colloidal gold method for rapid detection of novel coronavirus antigens. This product can be used for self-testing, which is more conducive to early detection.
We are also actively applying for registration with the State (Medicine Administration) Bureau. After obtaining the approval number, we will start production immediately, which can provide the society with more antigen detection products.
[Explanation] According to reports, most of the current detection of new coronaviruses uses nucleic acid detection, but the infected person itself is a virus mobile body. If you go to a specific place to do nucleic acid, it may cause the spread of the virus.
The advantage of antigen detection products is that the operation is simple, fast and convenient. It can be self-tested at home, and the results can be obtained in 15 minutes, which can effectively assist nucleic acid detection.
[Concurrent] Liu Peipei, R&D Director of Anhui Hanhai Boxing Biotechnology Co., Ltd.
Its main advantage compared with nucleic acid testing is that it can perform a test quickly and then on a large scale. It does not require professional equipment or professional technicians, and it is very convenient to perform a self-test at home.
At present, this antigen detection kit has high sensitivity and specificity. For example, its specificity and sensitivity have reached more than 95%. Its current specificity can reach 97%, so its accuracy is still relatively high. High.
[Explanation] According to Liu Peipei, the new coronavirus antigen detection kit adopts the principle of immunochromatography. As a supplementary method for nucleic acid detection, it only needs to collect samples such as nasal swabs and throat swabs to directly detect the virus itself. Find out early.
[Concurrent] Liu Peipei, R&D Director of Anhui Hanhai Boxing Biotechnology Co., Ltd.
If we take a nasal swab, we need to wipe the nasal mucus first, then use the nasal swab in the middle and lower part of the nasal cavity, and then perform a rotation, but it needs to stay for 15 seconds, so that the sample can be obtained.
Then the swab that has been taken is mixed in our diluent, and then the diluent is dropped into our card strip, and a test can be performed. If it is detected, only the C line, C The line means the control line means the control, that is, if the line is red, then the result is to prove that the sample is negative. If the C line and the T line show red at the same time, it proves that our sample is positive.
[Explanation] According to Wang Li, the new coronavirus antigen detection reagent product can be stored for about 18 months at room temperature, and there are no special requirements for transportation.
The company currently has a production capacity of 15 million servings per day.
At present, the production capacity is sufficient, and the raw and auxiliary packaging materials are fully prepared, which can produce 1 billion servings.
Liu Honghe reports from Hefei, Anhui
Responsible editor: [Wang Shanshan]