Because of the Omicron variant, covid-19 antigen detection began to fight in armor.
According to the latest news released by the center for the review center of the State Food Administration of the state food regulatory administration, the latest news released by the latest news released by the center for the review center of the state food regulatory administration of the state of the state of the state of the drug administration of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the drug administration of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the drug administration of the state of the state of the drug administration, in less than a week from March 11 to now, the state of the state of the state of the state of the drug administration has approved 12 covid-19 antigen self test reagents for self testing of the covid-19 antigen-19 antigen in less than a week from the week from March 11 to now, and in less than a week from March 11 to now, in less than a week from ( Lepu Medical Technology (Beijing) Co.Ltd(300003) . SZ), Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) ( Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) . SZ) Zhejiang Orient Gene Biotech Co.Ltd(688298) ( Zhejiang Orient Gene Biotech Co.Ltd(688298) . SH) and other listed companies.
Figure | covid-19 antigen self-test reagent approved in China, as of March 15, 2022
However, just when the market thought that listing could get a share in the huge market of antigen detection, it was soon poured cold water on the head by another news. On the 14th, Tianjin pharmaceutical procurement center issued a notice to carry out the centralized maintenance of covid-19 antigen detection reagent product information from the 14th.
Previously, Tianjin pharmaceutical procurement center has been responsible for the specific implementation of the joint procurement of high-value medical consumables organized by the state (i.e. “national centralized procurement of high-value consumables”), so the notice is also interpreted by the market as a signal that covid-19 antigen detection reagent is about to be purchased in quantity.
In this regard, the reporter of Kechuang ban daily also confirmed from reliable channels that in the future, Tianjin pharmaceutical procurement center will choose the opportunity to collect covid-19 antigen detection reagents when the market supply is relatively sufficient.
It is believed that once covid-19 antigen detection reagent is collected, its price will also usher in the ceiling. In addition, more and more products may be approved in the future, which will intensify market competition, as well as the impact of factors such as the start time of antigen detection of large-scale ordinary people or later than expected, the covid-19 detection concept fell for two consecutive trading days on the 15th and 16th
large scale home self-test needs still to be started
The concept of covid-19 antigen detection was detonated by a document.
Recently, the comprehensive group of the joint prevention and control mechanism of the State Council formulated and issued the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the scheme). The official announcement optimized the covid-19 virus detection strategy, added antigenic detection as a supplement to the original nucleic acid detection, and officially promoted the covid-19 virus detection mode of “antigen screening and nucleic acid diagnosis”
Why can “antigen detection” be entrusted with an important task at this time? This is mainly related to the rise of the Omicron epidemic.
Because the Omicron mutant has the characteristics of concealment and rapid transmission, and most of the related infections are asymptomatic, which greatly improves the difficulty of epidemic prevention and control. The two advantages of “early” and “fast” unique to antigen detection can best meet the urgent need of epidemic prevention at this time. It can screen out the possible infected persons at the first time and control the source of infection in the shortest time.
However, in terms of accuracy, antigen detection is not as good as “gold standard” nucleic acid detection, so it needs to be supplemented by large-scale nucleic acid screening to improve the ability of early detection.
According to the protocol, covid-19 antigen detection is applicable to three groups of people, including:
First, those who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms within 5 days;
Second, isolate observers, including those in home isolation observation, close connection and secondary close connection, entry isolation observation, sealing and control area and control area;
Third, community residents who need antigen self-test.
At the same time, the plan also gives different treatment methods for the test results of the above three groups. It can be seen that the first two groups of people can be defined as “specific people”, which implements closed-loop management, including transferring to the medical institution with fever clinic for nucleic acid test confirmation once covid-19 test is positive
in this way, the use of covid-19 antigen detection is also limited to special application scenarios, including grass-roots medical and health institutions, isolation observation, etc
In contrast, the third group is different. If there is a need for self-test in community pharmacies and retail pharmacies, self-test can be carried out according to the self-test plan this is equivalent to the scene of “self-test at home” for the general population
covid-19 antigen detection is limited to special scenarios. The difference between covid-19 antigen detection and home self-test of general population is that the market demand and capacity of the two are not at the same level, while covid-19 antigen self-test market space is obviously larger . Taking European and American countries that use covid-19 antigen home self-test as an epidemic prevention means as an example, according to relevant statistics, covid-19 antigen home self-test covers about 70% of the population in Europe and America.
However, although China now has the conditions for covid-19 antigen home self-test, not only a number of “self-test” products have been approved for listing, but also major retail pharmacies and online sales platforms have been making intensive preparations for the launch of products. However, it should be noted that the time for large-scale antigen self-test of the general population is actually not ripe .
On the afternoon of March 15, the joint prevention and control mechanism of the State Council held a press conference At the meeting, Li Jinming, deputy director of the clinical testing center of the National Health Commission, specially pointed out that the general population should not do antigen testing at will .
According to Li Jinming, the sensitivity of antigen detection reagents approved for marketing in China is about 75% – 98%, and the specificity is between 95% – 99%.
“Because China’s epidemic prevention and control measures are relatively good, the (covid-19) prevalence rate of people in most areas is less than one in a million. If you take the kit with sensitivity of 85% and specificity of 97% to the cities with tens of millions of people for screening, you will get 300000 positives, but only 9 of these 300000 positives are true, that is to say, most of them are false positives. Of course, if the test is negative, the result is reliable.” Li Jinming said.
“If the same kit is used in a population with a prevalence rate of 5%, about 60 of the 100 positive cases are true, and the missed detection rate is no more than 1%. therefore, antigen detection should be used in people with high risk and high prevalence of cluster infection .” According to Li Jinming.
therefore, it can be expected that under the epidemic prevention policy of dynamic clearing, the demand for home self-test of covid-19 antigen is still difficult to blowout. Covid-19 antigen home self-test needs to really start or will be released after the epidemic prevention restrictions in the future
continuously refresh the low online price
but even if it is only limited to people and scenarios, the demand for covid-19 antigen detection will increase compared with the past, which means that “price for quantity” is possible
Therefore, it can be seen that after covid-19 antigen detection reagent was approved, all localities quickly began to prepare for the centralized bidding and procurement of covid-19 antigen detection reagent, so as to reduce the price of detection reagent and reduce the burden of detection cost.
In March 14th, the Tianjin medical purchasing center issued the notice on carrying out the centralized maintenance of New Coronavirus antigen detection reagent, and announced that it will carry out the centralized maintenance of New Coronavirus antigen detection reagent products from now on. According to the reporter of Kechuang ban daily, although Tianjin pharmaceutical procurement center only maintains the product information of covid-19 antigen detection reagent, but the plan is to “select the opportunity for centralized purchase when the enterprise’s production capacity is up, the market supply is sufficient, and the supply exceeds the demand” .
On the same day, Shandong Medical Security Bureau also announced the implementation plan for special centralized procurement of covid-19 virus antigen detection reagents.
Then in March 15th, the relevant announcement issued by the official website of Guangdong drug trading center showed that the price of Guangzhou Wondfo Biotech Co.Ltd(300482) “New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)” has dropped to 9.8 yuan / person from the previous 16.8 yuan / share, a decrease of about 42%.
Shandong took the lead in completing the special centralized procurement of covid-19 virus antigen detection reagent of Lu Jin Alliance on March 16, and a total of 11 manufacturers participated in the competition. In the end, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) , Zhejiang Orient Gene Biotech Co.Ltd(688298) and other five enterprises were selected, and the price per person was reduced from the average price of more than 30 yuan in the market to less than 9 yuan, with an average decrease of 74.7%.
Among them, the lowest winning price is 7.9 yuan / person of Shenzhen Huada Yinyuan Technology Co., Ltd. (hereinafter referred to as “Huada Yinyuan”), a Bgi Genomics Co.Ltd(300676) subsidiary, and the highest price is 9 yuan / person of Tianjin boosses Biotechnology Co., Ltd., both of which are the lowest prices in China at present.
Figure | selection results of special centralized procurement of covid-19 virus antigen detection reagent of Lu Jin Alliance
From 9.8 yuan to 7.9 yuan, the price of covid-19 antigen detection reagent continues to decline, which also indicates a thinner and thinner profit space. “Has this market changed from blue ocean to red ocean?” The market inevitably has such concerns.
However, if you compare the export price, it is not difficult to find that China’s covid-19 antigen detection reagent is actually not low . According to the research of securities companies, the price of covid-19 antigen detection products in the United States is about $4, about $0.6-0.8 in Asia and Southeast Asia, about $1-2 in Australia, and about $0.5-1 in most other countries and regions. If the price of US $0.6 in Asia is converted into RMB, it is about 4 yuan / person.
” at present, the online price of 8-10 yuan must still have profit margin .” Insiders told the reporter of science and technology innovation board daily. However, it was also suggested that due to the rising price of raw materials, the material cost of covid-19 antigen detection will also increase in the future .
It is worth mentioning that in the special centralized procurement of covid-19 antigen detection reagent of Lu Jin Alliance, Huada Yinyuan won the bid at the lowest price of 7.9 yuan / person, which is quite surprising . Because the covid-19 antigen detection reagent of huadayin source adopts fluorescence immunochromatography technology. Previously, some insiders told the reporter of science and Innovation Board daily that the cost would be relatively high because the antigen detection reagent of fluorescence method needs to be used with supporting instruments.
However, the Bgi Genomics Co.Ltd(300676) related person did not agree with this, and replied to the reporter at that time that ” cost depends on whether each company has corresponding production capacity and material reserves “. This time, Huada Yinyuan won the bid at the lowest price, which also seems to be refuting the views of the market with practical actions.
In fact, in addition to quality, production capacity and material cost are also considered to be the key to whether reagent enterprises can win in the fierce competition and obtain greater profit space in the future .
