Author Tang Weike, intern Lu Sijia
China covid-19 virus antigen detection officially went to the public
On March 11, the official website of the National Health Commission published the notice on printing and distributing the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the notice).
"notice" said that the State Council decided to add antigen detection as a supplement on the basis of nucleic acid detection. Community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels
On March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. Since then, these five covid-19 antigen self-test products can be officially marketed to ordinary people.
this means that covid-19 antigen self-test model has been officially launched in China
In addition, the listing and sales of Chinese covid-19 antigen testing products in Wuxi Online Offline Communication Information Technology Co.Ltd(300959) retail channels have been started.
So, what is antigen detection? Self test positive how to do? Can it replace nucleic acid detection?
what is antigen detection? Self test positive how to do
what is antigen detection
At present, there are three main methods to detect whether the virus invades the human body: nucleic acid detection, antigen detection and antibody detection the first two belong to direct virus detection methods.
Compared with nucleic acid detection, antigen detection can be faster and more convenient, but the accuracy is low. It is generally used in the early stage of infection. After the outbreak, many countries recognized nucleic acid detection as the "gold standard" for covid-19 virus detection, and also promoted antigen detection as an effective supplement.
According to the application scheme for covid-19 virus antigen detection (Trial), the antigen positive results can be used for early diversion and rapid management of suspected people, and the selected antigen detection reagents must be approved by the State Drug Administration.
which groups apply
The above scheme specifies the applicable population for antigen detection:
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 with antigen self-test needs.
According to the plan, community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.
can replace nucleic acid detection
The National Health Commission specially stated that nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection. Antigen detection, as a supplementary means, can be used for screening of specific populations, which is conducive to improving the ability of "early detection".
in other words, promote the monitoring mode of "antigen screening and nucleic acid diagnosis"
According to the plan, if the grass-roots medical and health institutions have the ability of nucleic acid detection, nucleic acid detection should be the first choice; Those who do not have the ability of nucleic acid detection can carry out antigen detection.
When conducting antigen detection, isolation observers and community residents shall carefully read the instructions and standardize the operation. Further nucleic acid testing should be carried out for the antigen positive and negative results of the suspected population. The positive results of co19-vid antigen were not used as the basis for the diagnosis of virus infection.
antigen self-test positive how to do
According to the plan, the persons with positive antigen self-test, regardless of whether they have respiratory tract, fever and other symptoms, should immediately report to the community (Village) where they are located. The community (Village) should contact the emergency center to transfer the residents to the medical institution with fever clinic for nucleic acid testing according to the covid-19 guidelines for the transfer of persons related to the pneumonia epidemic.
At the same time, the sampling swabs, sampling tubes and test cards used by positive personnel are put into sealed bags and transferred to medical institutions for medical waste disposal.
For those with negative antigen self-test but symptoms, according to the scheme, it is recommended to go to the medical institution with fever clinic as soon as possible for nucleic acid detection; If it is inconvenient to see a doctor, you should isolate yourself at home, avoid going out for activities, and conduct antigen self-test once a day for 5 consecutive days.
antigen detection is a supplement, and nucleic acid detection is still the gold standard
The nucleic acid detection commonly used in China is called polymerase chain reaction (PCR) detection technology, which is essentially a gene amplification technology that is, the RNA fragment of covid-19 virus is reverse transcribed into double stranded DNA, and then amplified by DNA polymerase. The gene fragment carrying the virus is continuously amplified, and then captured by a fluorescent probe. When the amplified virus concentration reaches a critical value, there will be a fluorescent signal, which means that covid-19 virus exists in the sample.
The home self-help detection used abroad is an antigen detection technology.
After covid-19 virus infects human body, its viral protein can be used as antigen to stimulate human cells to produce specific antibodies. Antigen detection is to use the principle of the combination of virus antigen and antibody to detect whether there is virus antigen in people's oral and nasal secretions.
Zhang Wenhong, director of infection department of Huashan Hospital Affiliated to Fudan University, said earlier: "Antigen is like the 'clothes' worn outside the virus, and nucleic acid is the gene inside the virus. The detection method of antigen is to test the' clothes' from the antibody, and after synthesizing the specificity, the virus can be displayed. Nucleic acid detection needs to be completed through amplification, with higher detection sensitivity, but it takes longer to obtain the results."
(the 21st Century Business Herald reporter sorted out according to the public data. The nucleic acid price was based on the notice on further reducing the charging standard for covid-19 virus nucleic acid detection of disease control institutions issued by Guangdong Provincial Development and Reform Commission and Guangdong Provincial Department of finance at the end of 2021; the antigen detection price was calculated according to the price of covid-19 self-test kit approved by FDA)
Earlier, Europe, the United States, Japan and India were vigorously promoting family self-help testing.
The UK has been promoting rapid antigen detection since November 2020. After residents apply online, the detection reagent is mailed home. At the beginning of 2022, each American family can make an online reservation for four free kits to complete self-test at home.
Wu Shengjun, deputy director of the laboratory department of Run Run Run Shaw Hospital Affiliated to Zhejiang University, pointed out that the accuracy of antigen detection is related to many factors, such as product quality and sampling accuracy. If the sampling operation is not carried out in strict accordance with the instructions, it will have a great impact on the test results.
The notice recognizes the importance of nucleic acid detection. Nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection. Antigen detection can be used as a supplementary means for screening specific populations, which is conducive to improving the ability of "early detection". The issuance of the notice also means that China's covid-19 testing market will transition from "one dominant" nucleic acid testing to the graded diagnosis stage of "nucleic acid testing is the main and antigen testing is the supplement"
As for the price of antigen detection, Jin Dongyan, a professor and virologist at the school of medicine of the University of Hong Kong, previously analyzed in an interview that the ex factory price of reasonable range is about 5 yuan for one person, 8-10 yuan for two people, and the terminal price is no more than 20 yuan / person but he also said: "at present, the cost of antigen detection is affected by factors such as production scale and raw material source. At present, the cost increases greatly, and the supply of key raw materials is in short supply."
registration approval speed up
As one of the effective supplementary detection methods for covid-19 prevention and control, antigen home detection is expected to usher in the rapid growth of the market with its advantages of convenience and speed.
On March 12, the State Food and Drug Administration approved the application change of covid-19 antigen product self-test application of Beijing huaketai biology, Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan and Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) . Since then, five covid-19 antigen products have been officially launched, and the technical path covers many types with relatively simple requirements for instrument environment and operation, such as colloidal gold, latex and fluorescence immunochromatography, which provides an accessible choice for the medical staff in grass-roots medical and health institutions to carry out the rapid detection of covid-19 antigen in the plan.
(Figure: website of the State Drug Administration)
At noon on March 12, China Central Television News also reported that Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Huada Yinyuan, Guangzhou Wondfo Biotech Co.Ltd(300482) and Beijing huaketai had approved a total of five covid-19 antigen products, and applied for change for self-test application.
"The core of this registration change is whether it is really no longer limited to the use of the test reagent only by professional technicians. This means that after the registration change, the scope of use of the test reagent is further expanded and has the qualification to sell in retail pharmacies and online sales platforms." An in vitro tester in South China told the 21st Century Business Herald reporter.
Previously, some media revealed that Dashenlin Pharmaceutical Group Co.Ltd(603233) and Guangzhou Wondfo Biotech Co.Ltd(300482) had signed a strategic cooperation agreement on the distribution of covid-19 antigen self-test reagent, and Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen self-test reagent would be "launched" in Dashenlin Pharmaceutical Group Co.Ltd(603233) offline stores.
In response to the twenty-first Century economic report reporter's confirmation of Guangzhou Wondfo Biotech Co.Ltd(300482) , the company replied to the official statement issued on the 12 official account of Guangzhou Wondfo Biotech Co.Ltd(300482) , which said that the individuals and companies that had not authorized the company's legitimate authorization, authorized the adoption of electricity suppliers and other online channels, and claimed that they could sell New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold) products developed by our company, The company reserves the right to report the case to the relevant public security department and investigate the corresponding legal responsibility.
In addition, according to the official account of the Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy group, 12 days, the Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy ( Lbx Pharmacy Chain Joint Stock Company(603883) ) and Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) reached a cooperation. The first batch of COVID-19 antigen fast test products have been in logistics and transportation, and are expected to be sold on the shelves in stores. The first batch of products will be landed in the stores of Lbx Pharmacy Chain Joint Stock Company(603883) pharmacy in 12 provinces and cities including Shanghai, Hunan and Jiangsu. According to his introduction, the covid-19 antigen rapid test product of Guangzhou Wondfo Biotech Co.Ltd(300482) can get the test results in 15 minutes.
It is understood that few enterprises in China have been approved the medical device registration certificate before, because China is more strict in the registration and approval of covid-19 testing products.
The key points for technical review of antigen detection reagent registration previously proposed by the State Food and drug administration require that the number of enrolled cases may reach 500 according to the preliminary research. The clinical requirements of covid-19 antigen self-test kit in Europe and America refer to the interim guidance documents of who, including core indicators such as sensitivity, specificity, positive coincidence rate and negative coincidence rate, but there are no strict regulations on the number of clinical participants.
The newly approved five covid-19 antigen detection kit products also show that with the liberalization of antigen detection in China, the speed of registration and approval in China is also accelerating.
market gradually released
Among the five newly approved listed companies, Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) ), Shenzhen Huada Yinyuan holding company Bgi Genomics Co.Ltd(300676) ( Bgi Genomics Co.Ltd(300676) ), Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) ) are A-share companies, while Beijing jinwofu and Beijing huaketai biology have not yet entered the capital market.
Previously, Nanjing Vazyme Biotech Co.Ltd(688105) disclosed the performance express of 2021. The report shows that last year, the company achieved an operating revenue of 1.864 billion yuan, an increase of 19.13% over the same period of the previous year. Among them, the sales revenue of covid-19 related businesses (including diagnostic raw materials and terminal detection reagents) reached about 1.146 billion yuan, accounting for 61.48% of the operating revenue.
It is reported that during the reporting period, thanks to China's covid-19 epidemic prevention policy, the business development of the main customer groups of the company's routine business returned to normal and recovered in time during the reporting period. The company's conventional businesses including scientific research reagents, sequencing reagents, diagnostic raw materials, diagnostic reagents and instruments, cro services, etc. achieved a sales revenue of 718 million yuan, an increase of about 92% compared with the same period in 2020.
In covid-19 business field, the company mainly provides covid-19 nucleic acid detection enzyme raw materials and covid-19 antibody / antigen detection kit. Covid-19 nucleic acid detection enzyme raw material products are mainly PCR series, qPCR series and reverse transcription Series in the company's biological reagent products. The company's antibody / antigen kits are mainly exported overseas and have obtained the required overseas registration access. Combined with the recent overseas epidemic, it is expected that the export of relevant testing reagents will still be sustainable.
According to the annual performance express released by Bgi Genomics Co.Ltd(300676) in 2020, Bgi Genomics Co.Ltd(300676) achieved operating revenue and net profit of 8.397 billion yuan and 2.102 billion yuan respectively, with a year-on-year increase of 199.86% and 656.43%. Among them, the revenue from comprehensive solutions for precision medical testing increased by 8.7 times year-on-year; The revenue of infection prevention and control services increased 7.2 times year-on-year.
Guangzhou Wondfo Biotech Co.Ltd(300482) specializes in the R & D, manufacturing, marketing and service of rapid diagnostic reagents and supporting instruments. On March 8, he said on the investor interaction platform that the company's covid-19 business realized a revenue of about 800 million yuan in the first three quarters of 2021, most of which came from the overseas sales contribution of covid-19 antigen self-test products.
In addition to the first five enterprises mentioned above, many enterprises in China have been able to mass produce antigen detection kits, but previously related products were mainly used for export. According to the General Administration of customs, China exported covid-19 test kits worth 66.893 billion yuan overseas in 2021, and the national covid-19 reagent export exceeded 10 billion yuan in a single month in December 2021.
On January 14, Andon Health Co.Ltd(002432) announced that its subsidiary had signed an antigen self-test kit procurement contract with American ACC and came into force. The total amount of contract price and tax was up to US $1.275 billion, or 8.102 billion yuan.
In addition to Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) and other companies have also obtained covid-19 antigen home self-test products in the United States and other EUAs (emergency use authorization); In Europe, covid-19 antigen home self-test products of Guangzhou Wondfo Biotech Co.Ltd(300482) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Getein Biotech Inc(603387) and other companies have obtained CE certification.
Zhongtai Securities Co.Ltd(600918) Institute statistics show that from a global perspective, more than 200 enterprises have listed covid-19 antigen kits for sale, among which domestic brands quickly occupy the overseas market with industry-leading inspection effect and production and supply capacity, and the number of approved products accounts for more than half.
With the repeated global epidemic, the demand for virus detection continues to grow, and the antigen detection market is broad. Take the United States as an example. According to polarismarketresearch data, the market scale of covid-19 antigen detection in the United States in 2020 is US $520 million. It is expected that the market scale will reach US $4.56 billion in 2021 and US $8.7 billion in 2022.
With the implementation of the policy, China's demand for antigenic testing reagents will increase significantly Zhongtai Securities Co.Ltd(600918) in the research report, referring to the overseas distribution policy, with the official opening of China's antigen self-test kit, it is expected that the market scale of China's covid-19 antigen self-test kit is expected to reach 17.7-26.6 billion yuan per month and 2124319.2 billion yuan per year.
According to the website of the State Food and drug administration, at present, more than 30 new coronavirus 2019 ncov nucleic acid detection kits have been approved in China. Among them, the listed companies involved include Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) , Maccura Biotechnology Co.Ltd(300463) , Daan Gene Co.Ltd(002030) , Sansure Biotech Inc(688289) , Jiangsu Bioperfectus Technologies Co.Ltd(688399) , Autobio Diagnostics Co.Ltd(603658) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Shanghai Zj Bio-Tech Co.Ltd(688317) . Among the aforementioned companies, there are many cases in which the profitability has increased from tens of millions to hundreds of millions or even billions, and the performance has continued to grow in recent three years. At present, the number of approved antigen detection kits is far less than that of nucleic acid detection kits.
However, an analyst in the field of in vitro diagnostic reagents previously believed that due to the low technical threshold of antigen detection reagents, these manufacturers may soon launch their own antigen detection products and the purchase volume of these products in the future, whether there will be updated provisions in the epidemic prevention and control policy, and the actual inspection and detection scenarios will affect the performance of relevant companies
Cai Weiping, chief expert of the infectious disease center of the eighth hospital affiliated to Guangzhou Medical University, said that enterprises that have been affirmed in the foreign market will occupy a certain advantage. The reason is that the EU and the US Food and Drug Administration (FDA) emergency use license passed by it has a high gold content, and there are ready-made overseas clinical trial data available. Some materials can be directly applied in China. It is expected that these manufacturers will actively strive for the opportunity of listing in China.
covid-19 antigen self test how to test? This picture makes it clear
Some sources: Xinhua news agency, people's daily
