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The development of antigen swab test part I

Views: 0     Author: Site Editor     Publish Time: 2022-11-01      Origin: Site

From October 13th to 16th, the 85th China International Medical Equipment CMEF (Autumn) Expo was held in Shenzhen International Convention and Exhibition Center. At this expo, IVD companies such as Oriental Bio, Wanfu Bio, Zhijiang Bio, Baipsis, and Hantang Bio displayed their new crown reagent products.

Compared with previous CMEFs, the display of new crown reagent products this time is much more low-key, not only the number of manufacturers on display has decreased, but also the placement position no longer occupies the "C position". A reporter from the Securities Times learned from the meeting that the current export of new crown reagents is mainly antigen reagents, but exports have decreased compared with the first half of the year, and neutralizing antibody testing has not been widely used at home and abroad. demand.

Demand for antigen swab test

The new crown detection outlet has brought opportunities to the in vitro diagnostic (IVD) industry, and the performance of many companies has shown explosive growth in the past year or so. But from the current point of view, the opportunities brought by the new crown to enterprises are on the decline.antigen swab test part I - UDXBIO

"At present, the export of new crown reagents is mainly antigen reagents, and the export of antigen reagents is still strong, but not as good as in March and April." An international business staff of an exhibitor told reporters that the development of new crown detection reagents should be rapid, and now many large companies have put The market is full, and there are not many opportunities and shares left for latecomers.

From the perspective of customs data, the export value of my country's new crown reagents increased month by month from January to May. The export value in April and May exceeded 10 billion yuan, but the export value dropped significantly after June. In July and August The monthly export value of reagents dropped to about 3 billion yuan, basically the lowest level in a single month this year.

"When there is an epidemic, there will be a demand for testing." Some exhibitors also told reporters that 1 case was diagnosed in Erenhot two days ago, and nucleic acid testing for all employees was immediately started. This is already a normal practice, and the demand for testing products will not disappear immediately. . In the post-epidemic era, the demand for new crown combined detection reagents as routine reagents is still there.

At the 84th CMEF in May, many IVD companies displayed neutralizing antibody detection reagents. The industry expects that the rapid detection of new crown neutralizing antibodies is expected to become a strong demand after a large number of vaccines are vaccinated, with great market potential. Judging from the reporter's visit, the current sales of new crown neutralizing antibody reagents are still in the early stage, and they have not been widely used at home and abroad.

"Our neutralizing antibody reagents have been sold to a certain extent, but relatively few. Some governments do not support the testing of neutralizing antibodies after vaccination, which may require a process. However, we have developed several neutralizing antibody reagents. Maybe when there will be demand." The exhibitor told reporters.

The United States has a greater demand for antigen self-testing reagents

During the National Day, the FDA approved the emergency use authorization (EUA) of Aikang Bio's new crown antigen self-test reagent, which is the first EUA for the new crown antigen self-test reagent obtained by a Chinese IVD company in the United States.

According to the official FDA report, Aikang Bio-antigen self-test reagents will reach a monthly production capacity of 100 million reagents by the end of 2021, and a monthly production capacity of 200 million reagents by February 2022.

At the expo, Aikang Biotech staff told reporters that after obtaining EUA, the company focused on self-testing reagents for new crown antigens. In order to expand production capacity, the production capacity of other production lines was also used to produce self-testing reagents.

The reporter also learned from the expo that Orient Bio is also applying to the FDA for EUA for new crown antigen reagents, and is in the stage of supplementing clinical data. It is expected to be used as a major medical consumer product for home self-test in the future.