Whether covid-19 self-test will be implemented in China has always attracted social attention. On the evening of January 10, the information disclosed by “Daniel stock” Andon Health Co.Ltd(002432) (002432) on the interactive platform shows that China covid-19 self-test fetal movement, and Tianjin is studying the self-test suggestions of ” Andon Health Co.Ltd(002432) ” version.
Tianjin vid {123567}
The news that Tianjin took the lead in finding out the local Omicron mutant has aroused great concern in China.
In January 10th, the news conference of New Coronavirus disease prevention and control in Tianjin was held. Gu Qing, deputy director general of the Tianjin municipal government and director of the municipal health and Health Committee, said that as of now, the current round of Tianjin’s epidemic reports has been reported in 31 cases and 10 cases of asymptomatic infections. Other newly screened positive infections will be notified after further verification by the clinical expert group.
As of 15:00 on January 10, Tianjin has determined to track 1152 close contacts and 685 secondary close contacts, all of which have been isolated and controlled. All epidemic sites were subject to terminal disinfection. About 75000 people have been isolated and managed in this round of epidemic in Tianjin.
For Omicron mutant virus, Tianjin listed company – Andon Health Co.Ltd(002432) has detection reagents. On January 5, 2022, the company received the test performance test report of ihealth covid-19 antigen home self-test OTC kit for Omicron mutant virus. The report showed that the OTC kit detected 100% of Omicron active virus samples with a maximum CT value of 21.59 (n = 5).
Meanwhile, in the investor relations activity record disclosed on January 10, the company asked whether the company had made preparations for the “deltacron” strain, Andon Health Co.Ltd(002432) said that the company was paying close attention to the mutant strain and would carry out bioinformatics comparison as soon as possible, Start the recombinant N protein test in real time and carry out the test performance experiment after obtaining the mutant strain.
It is worth noting that the securities times · e company found that in this record of investor relations activities, it also revealed an important information – Andon Health Co.Ltd(002432) has submitted the proposal on using family self-test box to realize Omicron covid-19 epidemic prevention 1 + 1 to Tianjin epidemic prevention and control headquarters.
Andon Health Co.Ltd(002432) said that the infection of Omicron variant virus is strong. Now the number of patients tested positive in Europe and the United States is rising sharply. According to the latest article published by the British human anti-virus experiment, some patients already have the ability to detoxify before PCR test can detect positive. In fact, the process of queuing to brush nucleic acid itself is also an exposure. Firstly, the queuing process may last for several hours. Secondly, it is difficult to strictly control the safety distance between people when queuing. Based on this, the company has submitted the proposal on using family self-test box to realize Omicron covid-19 epidemic prevention 1 + 1 to Tianjin epidemic prevention and control headquarters.
Family self-test kit, commonly known as covid-19 self-test (antigen reagent). At present, in screening covid-19 infected persons, China adopts nucleic acid testing, while overseas countries such as Europe and the United States are using covid-19 self-test in large quantities. If the self-test suggestion of Andon Health Co.Ltd(002432) can be adopted, it will mean an important change in the way of screening covid-19 infected people in China.
At present, China has made significant strategic achievements in epidemic prevention and control, which is naturally inseparable from the credit of nucleic acid detection. However, with the change of covid-19 epidemic prevention situation and the emergence of self-test advantages, the aggregated epidemic has exposed the weaknesses and weak links of prevention and control, as well as the appeal to reduce the impact of social activities on economic activities and adjust covid-19 detection methods.
The record of investor relations activities also revealed that the relevant departments of Tianjin are studying the above scheme of Andon Health Co.Ltd(002432) . Although it is unknown whether it can be adopted in the end, the signal released deserves attention.
covid-19 self-test has become the main means in Europe and America
Covid-19 self-test reagent uses antigen reagent instead of nucleic acid reagent.
It is reported that antigen reagent combines the characteristics of high early diagnosis accuracy of nucleic acid reagent and rapid detection of antibody reagent. It can be detected on the first day of infection with covid-19 virus. It is easy to operate and does not need special equipment or instruments. The results from sampling to testing are generally within 20 minutes, and the accuracy is close to that of nucleic acid reagent. Therefore, after the United States, Britain and other countries used antigen reagents as the main means of covid-19 screening, the screening efficiency was significantly improved.
As early as November 2020, the UK carried out the first universal covid-19 virus “general test” in Liverpool by means of antigen reagent. At the same time, Liverpool will also use more reliable nucleic acid tests for suspected cases. British Prime Minister Boris said that this large-scale test is a powerful new weapon against covid-19. After the general survey, the local isolation time will also be shortened from 14 days to 7 days.
In fact, the United States, Britain, France, Germany and other countries have taken antigen reagents as the main means of screening covid-19 infected persons in fever clinics in places with dense flow of people such as airports and stations.
On its official website, the US FDA describes the effectiveness of the antigenic detection kit for detecting Omicron variant virus as follows: FDA is cooperating with NIH in the Radx project to study the performance of the antigen detection kit by using samples of patients infected with Omicron variant virus. Radx recently evaluated the performance of some antigen detection kits in detecting active virus samples from infected patients through preliminary research, which is the best way to evaluate its authenticity detection performance in the short term. Early data show that the antigen detection kit can detect Omicron variant virus, but its sensitivity may be reduced.
With the surge of covid-19 cases, especially the cases infected with the variant covid-19 virus Omicron strain, the overseas demand for detection boxes produced in China also began to increase.
According to customs statistics, in November 2021, the export value of diagnostic reagents (mainly covid-19 antigen reagents) with HS code 30021500 in China reached 4.165 billion yuan, an increase of 80.62% month on month, the first month on month increase after six consecutive months of decline.
On January 3, 2021, the number of newly confirmed cases of covid-19 in the United States exceeded 1 million, and it is estimated that more than 95% of them were infected with the covid-19 variant Omicron strain. Facing the soaring situation of new cases, the detection capacity of covid-19 virus in the United States is stretched. In this context, the U.S. government announced on January 4 that it would soon sign 500 million procurement contracts for covid-19 virus rapid detection boxes, which would be distributed to people in need free of charge after arrival.
different gold content in self-test certification
At present, there are many listed companies involved in household covid-19 testing business in China, including Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) , Beijing Hotgen Biotech Co.Ltd(688068) , Wanfu biology, Hangzhou Alltest Biotech Co.Ltd(688606) , Hangzhou Biotest Biotech Co.Ltd(688767) , Anxi biology, Shenzhen Yhlo Biotech Co.Ltd(688575) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) , Jiangsu Bioperfectus Technologies Co.Ltd(688399) .
From the nature of the self-test reagents of the above companies, most of them are EU CE certified. For example, Jiangsu Bioperfectus Technologies Co.Ltd(688399) announced in December last year that the covid-19 virus antigen rapid detection kit (self-test) had obtained the EU CE certification; Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 virus antigen self-test kit obtained EU CE certification in June last year and has been sold in Europe, Asia, the Middle East, Latin America and other countries and regions;
Beijing Hotgen Biotech Co.Ltd(688068) covid-19 antigen self-test product has been registered and approved by bfarm in Germany, MHRA in the UK and TFDA in Thailand.
According to China’s customs data, from the perspective of export market, China’s covid-19 antigen reagent was mainly sold to Germany, the United Kingdom, the United States, Canada and Greece in November 2021. Among them, Germany imported 1.308 billion yuan in November, an increase of 179.24% month on month, surpassing Britain and becoming the largest importer of covid-19 testing reagents in China. The import volume of Britain and the United States ranked second and third, reaching 715 million yuan and 346 million yuan respectively, with a month on month increase of 27.58% and 179.24% respectively.
It is not difficult to see from the above export quantities that the amount of self-test reagents used in the United States is much greater than that in Britain and Germany, regardless of the number of infected persons or the people who need to be tested. However, the antigen reagents exported to the United States are lower than those exported to Britain and Germany. The reason behind this is that there are very few Chinese reagent enterprises authorized by the U.S. FDA.
As we all know, FDA certification is the most demanding in the world. At present, there are only three Chinese enterprises approved by FDA for covid-19 home self-test, namely Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) and Aikang biology.
When waiting for detection, a large number of people run to the street to gather and wait for nucleic acid detection, which often increases the risk of covid-19 virus transmission. Why can covid-19 self-test products of Chinese listed companies be exported overseas for use by foreigners, and why can’t Chinese people use relevant antigen reagent products for self-test? The answer is that no covid-19 antigen reagent has been registered in China.
At present, there are few new cases in China and they are scattered. It is difficult for reagent manufacturers to collect enough clinical trial cases in three clinical institutions in accordance with the current regulations of the State Food and drug administration, which is similar to the situation that it is difficult for covid-19 vaccine to carry out phase III clinical trial in China.
In the view of the industry, according to the EUA registration requirements of FDA, the certified Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) and Aikang technology have completed the clinical trial of covid-19 antigen reagent in the United States. FDA’s approval is the most prudent in the world. In case of emergency, the registration of antigen reagents in China should allow relevant enterprises to quote overseas data, so as to improve the efficiency of clinical trials and approval.
Ma Shuai of Anxin Securities said that reviewing the number of new tests per month in Europe and the United States in the past two years, the emergence of new mutant strains, the promotion of family self-test products and the liberalization of isolation policy have played a great role in promoting the scale of covid-19 testing market. With the spread of Omicron, the further promotion of home self inspection products in the United States and the upcoming spring semester in January, the demand for covid-19 testing will continue to be stimulated. Based on the judgment of the future industry trend, it is estimated that the total covid-19 testing market scale in Europe and the United States is expected to reach US $3.391 billion in 2022, equivalent to about 22 billion yuan.
(source: e company)
