The scope of use of the new crown self-test kit announced that the effectiveness of antigen detection can reach up to 99%

The scope of use of the new crown self-test box has been announced.
Recently, the joint prevention and control mechanism of the State Council held a press conference
.
Mi Feng, spokesperson of the National Health and Medical Commission, said at the meeting that local clustered epidemics have occurred in many places in China recently, mainly due to the Omicron variant, which spreads quickly and is highly concealed
.
It was notified at the meeting that from March 1 to 14, a total of more than 15,000 infected people were reported in the local epidemic, involving 28 provinces
.
For the new crown antigen detection product (self-test box) that is currently hot in the industry, the press conference has made a detailed interpretation
.
At the meeting, Li Jinming, deputy director of the National Health Commission's Clinical Laboratory Center, pointed out that there are three main categories of "antigen testing application groups": One is patients who go to the community for medical treatment, with clinical symptoms of fever, and the symptoms are confirmed within 5 days.
In addition, such personnel, if the nucleic acid test is negative, can stay at home for 5 consecutive days of antigen testing (self-test)
.
Why test for 5 days in a row? Experts pointed out that usually within 5 days of new crown infection, one day the virus content is relatively high, so antigen testing can be done
.
If the antigen self-test is consistently negative, no intervention is required
.
The second category of personnel are those who are quarantined and observed, including home quarantine observation, overseas entry quarantine observation, and when there is a sporadic outbreak in an area, there will be close contact, sub-close contact, and those who stay in the closed and controlled areas without leaving their homes.
They can use Antigen self-test
.
It was also tested once a day for 5 consecutive days until the last nucleic acid test when the quarantine was lifted
.
A third group of people are residents who want to do their own testing
.
If the test is positive, the nucleic acid test should be done as soon as possible.
If the test is negative, the antigen can be tested at home when necessary.
If there are obvious clinical symptoms, go to the fever clinic for treatment, especially those with fever, loss of taste and smell must be At the fever clinic, loss of taste and smell is a very specific symptom of new crown infection
.
Jiao Yahui, director of the Medical Administration and Medical Administration Bureau of the National Health and Health Commission, pointed out that the State Food and Drug Administration has approved the antigen detection reagents, and the antigen detection reagents will be approved in succession in the future
.
Then through the way of online sales, sales will be more and more
.
The effectiveness can reach up to 99%.
At the meeting, Jiao Yahui, director of the Medical Administration and Hospital Administration Bureau of the National Health and Health Commission, pointed out that antigen detection is an important means of screening and an important supplement to nucleic acid detection, giving full play to the "early" and "early" antigen detection.
The two advantages of "fast" can immediately target the asymptomatic infection of the Omicron strain, which is relatively hidden and spreads quickly.
The use of antigen detection can screen out the possible infected people as soon as possible, and use the The source of infection can be controlled in the shortest time, supplemented by large-scale nucleic acid screening to improve the ability of early detection
.
So what is the difference between antigen testing and nucleic acid testing? What is the relationship between the two in the epidemic prevention and control system? Li Jinming, deputy director of the National Health Commission's Clinical Testing Center, pointed out that antigen detection is characterized by rapidity and simplicity.
To use a popular analogy, the colloidal gold test strip method is the usual pregnancy test method.
The method is similar and the operation is very simple
.
But nucleic acid detection has an amplification process, which is exponential amplification, that is, one becomes two, two becomes four, and four becomes eight.
The 10th power of 2 is 1024, and the 20th power of 2 is 100.
Ten thousand, 2 to the 30th power is 1 billion, and 2 to the 40th power is 1 trillion, which is an exponential expansion
.
Therefore, the sensitivity of nucleic acid detection is 100 to 1000 times higher than that of antigen detection
.
The antigen test is like this: if a person is infected with the new coronavirus, the virus content in the pharynx has a process from less to more.
If the amount reaches 1 million or even 10 million per milliliter, most of it can be done through antigen at this time.
Antigen screening is added to key groups, and most people can do it, so that the spread of the epidemic can be quickly controlled
.
The specificity of antigen detection can reach 99%, but the specificity of nucleic acid detection method is 100%, and there is no false positive in nucleic acid detection method, so nucleic acid detection has always been the way we determine the new crown infection.
One basis, one "gold standard"
.
Therefore, antigen detection cannot replace nucleic acid detection
.
When the antigen test is positive, the nucleic acid test must be used for confirmation
.
However, if the nucleic acid test is positive, regardless of whether the antigen test is negative or positive, the subject must be treated as a new crown infection or a confirmed patient to take measures
.
National requirements: provinces need to refine the implementation plan for antigen testing.
What should a resident do if the antigen test is positive at home? How does the city handle it? Jiao Yahui, director of the Medical Administration and Hospital Administration Bureau of the National Health and Health Commission, pointed out that the antigen testing plan puts forward a principled requirement.
If the residents test positive at home, they must report to the community in their jurisdiction, and the community will notify the emergency center and call the special The ambulance vehicles of the company will transfer the patients with positive antigen test to a medical institution with nucleic acid detection conditions in a closed-loop, and then carry out nucleic acid detection, and enter the process of management of infected persons
.
Jiao Yahui emphasized: We held a national teleconference to deploy this work, requiring the headquarters of each province to refine the implementation plan of antigen testing in their own provinces, especially for patients and residents who were found to have positive antigen tests in primary medical institutions.
To whom should a positive result be reported? We require the headquarters of each province to formulate a plan, and the most important thing is "the link from the positive antigen to the nucleic acid detection must be closed
.
" There is also a very important point to remind: residents of home antigen test, if once the antigen test is positive, all the swabs, test tubes, test cards you have used must be put into sealed plastic bags, work When the personnel come to the door, they must take it away, hand it over to the staff, hand it over to the medical institution, and dispose of it as medical waste
.
The registration threshold has been urgently raised, and it is difficult to "enroll"? In terms of the speed of examination and approval, the state has been running at full speed
.
Generally speaking, if the domestic new crown antigen self-test kit enters the special review process for innovative medical devices or the priority approval process for medical devices, the approval time is expected to take 3-12 months; if the three types of registration certificates are applied for conventional in vitro diagnostic reagents, the entire approval process The process may take 1-3 years
.
As soon as the domestic antigen test kits were opened, the demand in many regions with severe epidemic situation was strong.
The State Food and Drug Administration released a number of new crown antigen test kit approval changes in two days
.
As of press time, there are 10 new crown antigen self-test products applied by machinery companies on the market, namely-Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Biology, Beijing Huaketai Biology, Wanfu Thai Bio, Rejing Bio, Tianjin Boosaisi Bio, Chongqing Mingdao Jiexi Bio, and Beijing Lepu Diagnosis
.
Cyberblue Devices has learned that many IVD companies whose products have been approved abroad but have not yet been listed in China are also actively applying for certification, but the rapid increase in the market volume is often accompanied by the rapid upgrade of regulatory thresholds
.
At 9 p.
m.
on March 14, the Center for Device Review of the State Food and Drug Administration organized the release of "Key Points for Technical Review of the Registration of Novel Coronavirus Antigen Detection Reagents (Trial)"
.
The relevant registration review standards for the new crown antigen reagents are clarified: For the comparative test of antigen detection reagents and nucleic acid detection reagents, preliminary estimates are made based on existing research data.
There are no less than 300 negative samples
.
In order to fully evaluate the clinical performance of the product, among the positive samples, the samples with different viral loads (determined according to the test results of the comparative reagents) should have sufficient sample sizes: Take the positive judgment value Ct ≤ 38 of the nucleic acid detection reagent as an example, the recommended Ct value The number of positive samples with ≤30 should not be less than 170, and the number of positive samples with Ct value >30 should not be less than 30
.
For the comparative test of the non-professional user of the novel coronavirus antigen detection reagent and the professionally trained laboratory personnel, it is recommended to include at least 70 antigen-positive subjects and 70 antigen-negative subjects, including at least 10 positive subjects.
The test subject has not been confirmed to be infected with the new coronavirus before the test, and the infection positive status was detected during the clinical trial
.
Not only that, on the second day after the opening of the domestic antigen reagent market, the State Food and Drug Administration issued the "Notice on Doing a Good Job in the Quality and Safety Supervision of New Coronavirus Antigen Detection Reagents", requiring the strengthening of registration-related management, production and operation.
Link supervision and inspection and severely crack down on violations of laws and regulations
.
On March 15, the Office of the Shanxi Provincial Drug Administration issued the "Notice on Doing a Good Job in the Quality and Safety Supervision of New Coronavirus Antigen Detection Reagents" to implement the national regulatory requirements
.
According to Eight Points News, a dealer of an approved manufacturer is worried that at a time when supply is in short supply and application enthusiasm is high, substandard products entering the market or unreasonable abuse will bring a devastating blow to the development of the industry.

.
It is impossible for anyone to enter at will in a market that has just been opened.
It is most likely to appear in the early stage of market opening.
There is no conflict between the country's rapid increase in the threshold and the timely satisfaction of market demand
.
After 10 products stand out, how difficult is the next "admission"? It remains to be seen
.
In the afternoon of March 15th, Changchun City, Jilin Province held a press conference on epidemic prevention and control.
According to reports, according to the recent dynamic changes of the epidemic situation, Changchun City has further increased reserves on the basis of existing material reserves.
efforts to ensure the need for anti-epidemic work
.
In particular, it is necessary to increase the procurement of new crown antigen detection kits
.
As of 12:00 today, Changchun City has issued 2.
65 million copies, and other sources of goods are being organized one after another
.
On the morning of March 15, the Jilin Province epidemic prevention and control work press conference stated that the province's medical and epidemic prevention materials can only meet the needs of 2-3 days, and it is going all out to win the support of all parties.

.
It is understood that Jilin Province is currently promoting the "antigen screening, nucleic acid diagnosis" monitoring mode, adding antigen testing as a supplement on the basis of nucleic acid testing
.
The combination of nucleic acid and antigen detection can effectively improve the detection capacity, optimize the organization and implementation, and find out the background of the epidemic as soon as possible
.
The Jilin Provincial Department of Industry and Information Technology has immediately communicated and connected with antigen reagent manufacturers such as Beijing Rejing Bio and Guangzhou Wanfu Bio through the channels of the Provincial Health and Health Commission and the National Health and Health Commission, and ordered 12 million nationwide in a short period of time.
Human antigen detection reagents (8 million for Beijing Rejing Bio, 3.
1 million for Guangzhou Wanfu Bio, 400,000 for Beijing Anwofu, and 500,000 for Chongqing Mingdao Jietest Bio)
.
On March 13th, 46,000 copies arrived (36,000 copies of antigen reagents were delivered to Jilin University at 22:00); 8 million copies arrived at 13:00 on March 14th
.
At present, the epidemic prevention and control in Jilin Province is at the most critical period, and the daily consumption of nucleic acid testing materials in Changchun and Jilin is gradually increasing
.
The Provincial Department of Industry and Information Technology is actively communicating with Sinopharm Group, Beijing Jinwofu, Beijing Rejing Biology, Guangzhou Wanfu Biology and other enterprises.
The procurement scale of antigen reagents ensures sufficient supply of subsequent nucleic acid screening materials
.
Large orders have been issued, and centralized procurement is also on the way
.
According to the previous documents, the antigen detection reagents provided by primary medical and health institutions are included in the centralized bidding and procurement, and the price of testing reagents can be continuously reduced and the burden of testing costs can be reduced through centralized procurement at the provincial level
.
According to the observation of Cyber ​​Blue, the Tianjin Pharmaceutical Purchasing Center and the Guangdong Provincial Drug Trading Center have successively carried out the maintenance of the information of the new crown antigen reagent within two days, and the latter has previously carried out the purchase of antigen reagents
.
People in the industry regard it as a centralized acquisition signal
.
There is a frame of reference in terms of price
.
From April to May 2021, the Guangdong Provincial Drug Trading Center will carry out the new coronavirus (2019-nCoV) detection reagent alliance regional group procurement
.
The quotation requirement for antigen detection reagents is ≤ 30 yuan/person, and the purchase demand is 203,505 persons.
Guangzhou Wanfu Biotechnology Co.
, Ltd.
was selected at 16.
80 yuan/person
.
On the retail side, the price of each platform is slightly different.
The unit price of products on Tmall Health, Meituan Maidao, and JD Health is concentrated around 20-30 yuan
.
As of press time, Cyberblue Instruments has searched for the new crown self-test kit on Tmall Health.
The price of 1 person for the Thermal View biological kit is 24.
8 yuan, and the 20-person kit for Wanfu Bio is 480 yuan, with an average of 24 yuan for 1 person.

.
According to media reports, the new crown antigen reagent is currently priced at about 6 US dollars, or about 38 yuan, in the United States, and about 1.
5 euros, or about 10 yuan in Europe, and this price also includes shipping and distribution at all levels.
business profits and other costs
.
Huang Ailong, a member of the National Committee of the Chinese People's Political Consultative Conference and president of Chongqing Medical University, has previously analyzed that the reasonable range of antigen testing is about 5 yuan per person, 8-10 yuan for 2 people, and the terminal price does not exceed 20 yuan per person
.
However, at present, the cost of antigen testing is affected by factors such as production scale and source of raw materials.
At present, the cost has risen sharply, and the supply of key raw materials is in short supply
.
Industry insiders expect that the overall price of the product will further drop after the number of approved products increases, the production capacity of various companies increases, and the supply increases
.