Wen | Zhang Shuxia, a reporter from the "Finance and Economics National Weekly."]
Covid-19 antigen testing products are coming!
"About a week or so to arrive, can now be booked, non-pharmacy members retail price of 656 yuan / box, there are 20 reagents in it." The staff of a store in Shenzhen of Dashenlin Pharmacy told the reporter of The National Weekly of Finance and Economics that it was 32.8 yuan per reagent.
In addition, the reporter saw on an e-commerce platform that another antigen detection reagent has also been pre-sold on the shelves, and the price after the discount is 486 yuan / box, which is converted down to 24.3 yuan per reagent.
With the release of the new crown antigen self-test by the comprehensive group of the joint prevention and control mechanism of the State Council, offline pharmacies and e-commerce platforms in Beijing, Shanghai, Shenzhen and other places have launched the pre-sale of new crown antigen self-test products. Next, in addition to doing nucleic acid testing, home self-testing of new crown virus infection becomes possible.
So why are countries starting to promote antigen screening? Compared with nucleic acid testing, what are the characteristics and advantages of antigen screening? Who is it suitable for?
Faced with many problems, the reporter of the Financial National Weekly conducted an investigation and interview.
10 products were officially launched
On March 11, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council issued the "Application Plan for Antigen Detection of the New Coronavirus (Trial)" (hereinafter referred to as the "Plan"), in order to further optimize the new crown virus detection strategy, on the basis of nucleic acid testing, antigen detection is added as a supplement.
On March 12, the State Food and Drug Administration approved the application change of the self-test application of new crown antigen products of Nanjing Nuoweizan, Beijing Jinwolf, Shenzhen Huada Ingenyuan, Guangzhou Wanfu Biologics, and Beijing Huaketai Biologics. On March 13, the State Food and Drug Administration approved the registration application of five new crown antigen products, including Wantai Biologics, Heatscape Biology and Boossex Biology. As of press time, 10 new crown antigen self-test products have been officially launched.
Since the outbreak of the new crown pneumonia epidemic, nucleic acid testing has been the "gold standard" for the diagnosis of new crown virus infection. Why is antigen screening now being promoted?
"After the emergence of the Omiljung variant, the spread of the virus is accelerating. If our detection speed is still as completely dependent on nucleic acids as it was in the first place, we will face certain difficulties. Zhang Wenhong, director of the National Center for Infectious Diseases And director of the Department of Infectious Diseases at Huashan Hospital affiliated to Fudan University, said.
Recently, the national epidemic has shown a multi-point and local outbreak trend, mostly caused by the Aomi Kerong BA.2 subtype. According to data from the National Health Commission, on March 12 and 13, the number of new local cases in China has exceeded 1,000, and the number of asymptomatic infected people has also increased significantly.
"Because the symptoms caused by Omikejong are milder, more difficult to detect, more easily transmitted, more difficult for group prevention, and a major challenge." Wu Zunyou, chief expert in epidemiology at the Chinese Center for Disease Control and Prevention, said that mild disease makes the virus extremely insidious and difficult to identify. There are more mild patients staying at home, spreading in the family, and only when the severely ill patients appear, they are only found, and a large piece of infection has been transmitted by this time.
▲Residents of a community in Jiading District, Shanghai are queuing up for nucleic acid testing. Photo/Journal
According to experts, due to the difficulty of finding a large number of infected people in the early stage, the pressure of nucleic acid testing at the grass-roots level in the country has surged, and the introduction of antigen screening is precisely to promote the early detection of infected people and improve the sensitivity of monitoring and early warning.
Zhang Wenhong said that antigen testing is used as a supplementary means of screening, if it is positive, it can basically be diagnosed, if it is negative, it is necessary to test several times to improve the sensitivity and positive rate, or to confirm the diagnosis through nucleic acid testing.
This means that with rapid antigen testing, more patients with mild diseases are expected to be detected early and take measures such as isolation in time, thereby cutting off transmission and helping to control the epidemic in time.
During the two sessions of the National People's Congress this year, Huang Ailong, member of the National Committee of the Chinese People's Political Consultative Conference and president of Chongqing Medical University, proposed that the rapid detection of antigens has many advantages such as simple operation, fast and efficient, wide application, low cost, safety and reliability, which can greatly reduce the burden on medical staff and medical and health institutions.
To this end, Huang Ailong suggested that a normalized epidemic prevention and control model combining "large-scale rapid detection of antigens based on home self-testing + targeted small-scale precision nucleic acid detection" should be built as soon as possible.
Previously, such rapid test products have been popularized in many countries. Singapore, the United Kingdom, Germany and other countries were the first countries to use it, and the United States also began distributing 500 million household rapid test kits to people in January this year to fight the epidemic.
Faster and more convenient, but only assisted
Antigen screening helps improve "early detection" because it is faster and easier to do.
"Antigens are like clothes worn by viruses, and nucleic acids are genes in viruses. The antigen detection method is to detect the 'clothes' from the existing antibodies and display it through some indicative methods. Nucleic acid testing requires gene amplification to improve its sensitivity. Zhang Wenhong introduced.
Because of this, nucleic acid detection has high requirements for the laboratory environment, testing personnel, and instruments, high detection sensitivity, good specificity, and generally produces results in 2 to 3 hours.
The antigen test has low requirements for the laboratory, and it is convenient and fast, and residents can test themselves at home, which is as easy to operate as a pregnancy test stick, and the results are available in about 15 minutes.
In addition, the kit is also very convenient for room temperature transportation and storage, material allocation, logistics and transportation, etc., which can become a powerful supplement to epidemic prevention and control under various epidemic prevention conditions.
However, the disadvantages of antigen detection are also more obvious, there is no nucleic acid sensitivity, and it can only be detected when the viral load is relatively high.
Therefore, at present, antigen detection is mainly used as a supplementary means for the screening of specific populations, and positive results can be used for early triage and rapid management of suspected populations, but it is not yet a substitute for nucleic acid detection, which is still the basis for confirming the diagnosis of new coronavirus infection.
"Antigen detection is important for the occasion." A person from a provincial CDC told the "Finance and Economics National Weekly" reporter that the best application scenario is for detection when symptoms appear, and it is also suitable for use in gathering environments, such as nursing homes, schools or screening for large-scale activities.
The "Plan" clarifies the applicable groups for antigen testing: first, those who go to primary medical and health institutions for treatment, accompanied by respiratory tract, fever and other symptoms and have symptoms within 5 days; second, isolation and observation personnel, including home isolation observation, close contact and sub-close connection, entry isolation observation, sealing and control area and control area; third, community residents with antigen self-testing needs.
In the "Basic Requirements and Procedures for Self-Testing of New Coronavirus Antigens" issued together with the "Plan", it is mentioned that antigen testing is generally used for sample testing during the acute infection period, that is, within 7 days of the appearance of symptoms in suspected people.
▲Schematic diagram of antigen self-testing process. Figure/ Basic requirements and procedures for self-testing of new coronavirus antigens
What if the antigen tests positive?
According to the "Plan", if the antigen test is positive, regardless of whether there are respiratory tract, fever and other symptoms, residents should immediately report to the community (village and town), and the community (village) will contact the emergency center to transfer the residents to the medical institution that has set up a fever clinic for nucleic acid testing, and then take corresponding measures according to the nucleic acid test results.
Asymptomatic residents with negative antigen tests can be closely observed and then undergo antigen testing or nucleic acid testing when necessary; symptomatic residents are recommended to go to a medical institution that has set up a fever clinic as soon as possible for nucleic acid testing; if it is inconvenient to seek medical treatment, they should self-isolate at home, avoid going out, and conduct antigen self-testing once a day for 5 consecutive days.
The retail price is 20 to 30 yuan per serving, and it arrives within this week
After the antigen testing was officially released on March 11, many manufacturers, retail pharmacies, and e-commerce platforms failed to rest on weekends, and non-stop arranged reagent orders, production, reservation, distribution, shelves, etc.
The "Plan" mentions that if community residents have self-testing needs, they can purchase antigen detection reagents for testing through retail pharmacies, online sales platforms and other channels.
"The phone is all broken, because it has just been approved, there is no stock, production is officially scheduled on Monday, and it is expected to be shipped this Thursday, and the reservation needs to be queued." The sales staff of a province in the north of Nanjing Nuoweizan revealed to the reporter of the "Finance and Economics National Weekly" that the current manufacturer's shipment price is 15 yuan / copy.
It is worth mentioning that in May last year, the Guangdong Provincial Drug Trading Center announced the selected price information of the regional group of the new crown virus detection reagent alliance with quantity procurement, of which Wanfu Bio won the bid exclusively in the antigen detection reagent group, and the winning bid price was 16.8 yuan / person. However, at that time, antigen testing was only used by professionally trained personnel and had not yet been approved for home self-testing.
A number of chain pharmacies have also begun to sell preheating.
On March 12, the people's pharmacy said that in cooperation with Guangzhou Wanfu Biology, the first batch of new crown antigen rapid test products have been in the logistics and transportation, and are expected to be sold in stores in 12 provinces and cities such as Shanghai, Hunan and Jiangsu in the near future.
The reporter consulted the people's big pharmacy stores in Beijing, Shanghai, Shenzhen and other places, and its staff said that they could arrive within a week, and they could add WeChat to book in advance, and the current retail price was about 600 yuan / box, containing 20 reagents.
The staff of some city stores of chain pharmacies such as Dashenlin Pharmacy and GUODA Pharmacy also said that they would accept reservations, and the retail price was about 30 yuan / copy.
However, the pace varies from place to place. The clerks of many pharmacies in Tianjin, Anhui and other places told reporters that "there is no stock at present, and it depends on the situation whether the specific order is ordered later."
▲ A number of e-commerce platforms have launched the "new crown antigen self-test agent" sales preheating. Photo/Screenshot of the special page of the e-commerce platform
According to the reporter's understanding, a number of e-commerce platforms have specially opened a special page for new crown antigen testing for promotion, and some platforms have opened reservations, and the prices are also different.
For example, on the Meituan takeaway platform, the online price of Guangzhou Wanfu biological reagents is 29.8 yuan / copy, and the price of Beijing Jinwolf reagents is 32.8 yuan / copy, "expected to be shipped in about 15 days"; on the Taobao platform, Nanjing Nuoweizan 20 people's reagents are priced at 486 yuan / box, 24.3 yuan / copy, customer service told "4 days to ship, inventory is very tight".
On the Meituan takeaway platform, the reporter successfully purchased two reagents. It is worth mentioning that when purchasing epidemic prevention and control drugs, it is necessary to register personal information such as personal name, ID card number, mobile phone number, symptoms, and whether there is a history of travel abroad or high-risk areas within 14 days, but the purchase of testing reagents does not need to be registered at present.
For the current price of testing reagents, there are different opinions on the Internet, some netizens feel that the price is "acceptable", and some netizens say that it is "a bit expensive". According to industry insiders, with reference to the price trend of nucleic acid detection reagents, the price of antigen detection reagents is expected to further decline.
In addition, the reporter of the National Weekly of Finance and Economics also learned that recently, many communities in Haicang District of Xiamen City, Yuhang District of Hangzhou City and other places have distributed free antigen test kits to residents.
▲ A community in Haicang District, Xiamen City, distributed a free self-test agent box to residents, including a nasal swab (sampling stick), a sampling tube with liquid inside, and a sealed test card. Photo/Screenshot of Weibo
A source in Hangzhou told reporters that on March 14, a case of positive screening in Yuhang District was transferred to a relevant hospital for further verification after using a community-issued antigen detection reagent to test positive for itself. The reporter called the Yuhang Street Epidemic Prevention Office in Yuhang District, and the staff said that "the situation is true."
For the distribution of reagents, a staff member of a community neighborhood committee in Haicang District, Xiamen City, told reporters in an interview, "At present, the distribution has been suspended, or the hospital test results shall prevail."
Investors pay close attention and the market reacts strongly
On the day of the release of the "Plan", the stock prices of listed companies related to antigen testing such as Wanfu Biology, Oriental Biologics, and BGI Gene rose sharply.
On March 14, stimulated by the good news, the new crown antigen detection plate opened sharply, Novizan and Saili Medical opened up and stopped, and Heatscape Biology, Wanfu Biologics, and BGI Gene opened more than 10%.
On the investor exchange platform, the discussion of antigen detection and related enterprises is heated, and many companies are asked whether there are antigen reagent products approved and when to sell.
▲The interactive platform of the Shenzhen Stock Exchange, investors pay close attention to the relevant situation of antigen detection.
In foreign markets, due to the continuous fermentation of the epidemic in Europe and the United States, the number of new crown infection cases has continued to increase significantly, the demand for new crown antigen detection reagents has increased significantly, and many domestic enterprises have achieved good revenue as major suppliers.
For example, Thermid biotechnology announced that it is expected that the annual net profit in 2021 will be 2.00 billion yuan to 2.35 billion yuan, an increase of 1684.65% to 1996.97% year-on-year, and the substantial growth in overseas new crown testing reagent revenue is the main reason. Dongfang Bio announced that it is expected to achieve a net profit of 4.72 billion yuan to 5.12 billion yuan in 2021, an increase of 181.45% to 205.31% year-on-year, also due to the company's high sales of new crown antigen reagents in the European market.
So, with the liberalization of new crown antigen testing in China, how much market space can it bring to relevant enterprises, and is it expected to bring the next capital highland after masks, nucleic acids, vaccines and other anti-epidemic materials?
The capital market is positive about this. Huaan Securities Research Report believes that from a rational perspective combined with three types of application scenarios, the market size of diagnosis and treatment testing needs of grass-roots medical and health institutions is about 5.5 billion yuan, the testing demand of isolation observers is about 2.5 billion yuan, and the demand for self-inspection of community residents is about 24.9 billion yuan, with an overall total of more than 30 billion yuan.
Zhongtai Securities Research Report said that with reference to the overseas new crown antigen self-test kit issuance policy, it is expected that the domestic new crown antigen self-test kit market is expected to reach 17.7 billion - 26.6 billion yuan in a single month.
According to public information, although only 10 antigen detection reagents in China have been approved for self-testing, many domestic antigen detection products have long been approved and sold in Europe or the United States.
Taking Germany as an example, the products of the mainland's Aikang Biology, Anxu Biology, Wantai Biology, Heatscape Biology, Mingde Biology, Botuo Biology and other companies have been approved by the German Food and Drug Administration for household use, and other companies such as Wanfu Biological, Yahuilong, Oriental Biological, Lepu Biological and other products have also obtained EU CE certification.
Next, considering the potential demand for domestic antigen detection, many enterprises may accelerate the change of domestic registration application or self-test application application.
In addition, some companies have also disclosed their own production capacity, such as Beijing Jinwolf Bio said that the company's production capacity will be increased to 1.7 million copies per day, Wanfu Bio said that the daily output will reach 1.5 million copies, Dean Diagnostics said that the current production capacity of new crown antigen testing products is 600,000 copies per day, and will be increased to 1 million copies per day in the future.
However, the final market space of the new crown antigen reagent still needs to be clarified by many questions. For example, whether residents need to file antigen detection reagents for the record, whether the health code will change color and pop-up windows after purchasing reagents, whether there is a relevant monitoring and supervision mechanism after self-testing is positive, and whether a negative test can be used as an access certificate for public places and traffic facilities...
The answers to these questions are directly related to whether the new crown antigen reagent can eventually be accepted by the public, and also directly affect its market performance.
Cautious industry insiders believe that antigen reagents are only an auxiliary means of testing for new crown infections, not the gold standard, and in the case of self-payment purchases, residents' willingness to test may not be as positive as imagined. "At present, the policy is unclear, I do not dare to buy goods, for fear of pressing my hands after entering." A pharmacist said.