The first batch of new crown self-test kits were launched, and Jilin ordered 12 million copies. Can it solve the urgent need of the epidemic?

The author of this article: Tun Tun

On March 11, the National Health and Medical Commission issued a new coronavirus antigen detection application plan, and decided to supplement the nucleic acid detection with antigen detection.

According to the approval documents of the State Food and Drug Administration, there are currently Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Bio, Beijing Huaketai Bio, A total of 10 companies including Beijing Rejing Biology, Beijing Wantai Biology, Tianjin Boosaics Biology, Chongqing Mingdao Jiexi, and Beijing Lepu Diagnostics have approved their new crown antigen self-test products.

Residents in many places have been issued, and the e-commerce platform is online

Since the announcement on March 11, multiple communities have begun distributing kits, and multiple e-commerce platforms have also been launched.

Lin Meng, who lives in Yuhang District, Hangzhou, received an antigen rapid test kit issued by the community on the evening of last Sunday (March 13). Lin Meng told Lilac Garden, “Everyone who lives in Yuhang District around me has received it. Each community organizes everyone to use the self-test box to test, and also took a video to teach how to use it. The test results are required to be uploaded to the community.”

Notice of antigen kit collection in Lin Meng’s community

Judging from the pictures provided by Lin Meng, the manufacturer of the kits distributed by Yuhang District is Boto Bio, not one of the 10 companies approved this time. Botto Bio responded to a reporter from China Securities News later, saying that this move was to fight the epidemic, and it was donated at the request of the government and the Epidemic Prevention Office, not a sales act.

Kits distributed by Lin Meng’s community

Yesterday afternoon, Jilin Province stated at the epidemic press conference that it has ordered 12 million antigen detection reagents from reagent manufacturers, and 36,000 copies have been delivered to Jilin University. In addition, according to feedback from several Dingxiangyuan Weibo users, some communities in Haicang District of Xiamen City have also distributed antigen kits.

Lilac Garden has called a number of pharmacies in Shanghai and Hangzhou, all of which have indicated that they have begun to accept reservations. The staff of Sinopharm Pharmacy said that the supply is in Shanghai, and it is expected to be delivered to offline stores as soon as Friday. Delivery time is unclear.

It is understood that Meituan, Ele.me and other e-commerce platforms have launched the new crown antigen self-testing agent, which is currently in the pre-sale stage, and the fastest delivery time is Thursday ( March 17), mainly from Jinwofu, Rejing Bio, Wanfu, Novozymes and other manufacturers.

Single price 20-35 yuan

In terms of price, the price of the kit for 1 person on each platform ranges from 20 to 35 yuan; the price for 5 people is about 120 yuan; the price for 20 people ranges from 388 to 411 yuan ; RMB 628 for 25 persons. The Ele.me platform specifically stated in the product details that “the market price fluctuates violently, and the pictures are taken according to the actual demand. Please do not take more pictures.”

Swipe to view the price of the self-test box for each platform

At present, in overseas areas where antigen self-test kits are widely used, the main price in the United States is 2 sets/box, and the price is about 20 US dollars (equivalent to RMB 128); 1 set in a local pharmacy in the Netherlands The package price is about 2 euros (equivalent to RMB 14); the local price in Singapore is about SGD 4.9 (equivalent to RMB 22).

In addition, the US and UK have opened a free claiming channel.

The United States can apply for it through the official website of the Postal Service, and 2 boxes (4 tests in total) will be sent home by courier, but each address can only apply once. The second round of self-test box applications has just opened recently. According to Jia Qin, a Chinese doctor in the United States, it took about two weeks after his last application to receive the test kit. “When Omicron became popular in the U.S. last December, the kits were out of stock for a long time.”

Image source: USPS website

The official guidelines of the British NHS show that eligible applicants can fill in the information on the official government website, obtain a verification code, and then go to the designated pharmacy to collect it, or they can go to the pharmacy to collect it for free. British student Wang Shu told Lilac Garden, “You can apply for one box at a time, and there are 10 test kits in it. You can get it after you run out.” But the British government announced that it will no longer provide free antigen self-testing after March 31. box.

Image source: UK government website

Risk: What happens after a positive test?

According to interim guidelines issued by WHO, rapid antigen tests can rapidly identify clusters due to their ease of use and rapid results and support epidemiological investigations and public health interventions. If a positive antigen test result is found from multiple individuals, it is highly suggestive of the outbreak of the new crown epidemic, and appropriate isolation and control measures should be implemented as soon as possible.

In this process, the reporting and management of positive self-test results are the key links.

Take overseas areas that have been widely used as an example. Due to the increasingly relaxed epidemic prevention measures, most asymptomatic and mild positive patients are quarantined at home. A number of overseas Chinese told Lilac Garden, “There is no monitoring and tracking mechanism for the self-test box, and whether to report and isolate is entirely dependent on self-consciousness.”

Shi Qi’s test results using an antigen kit for 5 consecutive days after contracting COVID-19

British student Wang Shu told Lilac Garden that although the official guidelines require positive reports, they were not reported after someone around them tested positive. “In fact, even if you don’t report, there is no way to find out that you are positive. This is different from nucleic acid testing, which will be registered in your medical information.”

Perhaps because of the risk of concealment, Shi Qi, an international student from the Netherlands, introduced that presenting a negative test certificate of the test box has gradually become a kind of “etiquette” in some international student circles and workplaces. . “If you are attending a meeting or gathering with a high-risk person, such as a pregnant woman or someone with asthma, it is generally ethical and respectful to get tested before going.”

Li Tong, Chief Physician of the Department of Infectious Diseases, Beijing You’an Hospital Affiliated to Capital Medical University, once said to Dingxiangyuan, “I purchased an antigen test kit, and after testing positive, will I report it? Will they take the initiative to isolate themselves? These are all things that we need to consider. The person concerned may be worried about social discrimination and the cost of isolation. Instead, they choose to conceal the report, and even avoid nucleic acid testing and medical treatment.”

Hokkaido University Master of Neuroscience, Senior Medical Consultant Zhuang Shili suggested: “Our country should have some means to reduce the risk as much as possible, perhaps by scanning the health code, and then scanning the two-dimensional reagent on the reagent Binding of personal identities through the code, and then the results must be forced to be uploaded, and control is achieved in this way.”

According to the basic requirements and procedures of the new coronavirus antigen detection issued by the State Food and Drug Administration, personnel during the quarantine observation period need to conduct an antigen self-test every day for the first 5 days. The whole process requires community participation and supervision. This morning, Lin Meng received a notification from a community in Yuhang District requiring the use of the self-test box for the second round of testing. According to the request, she needs to receive and complete the test on the spot.

Notice of the second inspection of Lin Meng’s community

Nucleic acid testing remains the gold standard

In addition to reporting results, another concern is accuracy. According to WHO recommendations, the rapid antigen kit used should meet the requirement of ≥80% sensitivity.

Many international students said they had experienced false positives or false negatives.

Shi Qi, an international student from the Netherlands, told Lilac Garden that her friend “used the kit when he had some symptoms of the new crown before. He tested it twice on the same day, one test was negative and one test was positive.”

British student Wang Shu also said that there are “super many” false negatives around her. According to her personal experienceGenerally speaking, the test kit will display two bars only in the case of strong positives. “If it is a weak positive, it will take about 10 minutes to display the second shallow bar, but many people do not wait that long. Probably didn’t notice the second.”

Current sensitivity comparison of mainstream antigen kits in my country

(Photo source: Zhongtai Securities)

In the Netherlands, the United Kingdom and other countries, self-test kits are widely used in mild cases, close contact, entry isolation and some daily routine tests. For more serious symptoms such as high fever, nucleic acid is still used. detection. In scenarios such as passage and travel, the Dutch government only recognizes the results of nucleic acid testing, not antigen testing.

Image source: Dutch government website

American student Xue Hua also told Lilac Garden, “Nowadays, nucleic acid testing is mandatory in universities every week, and the test results are directly linked to the campus system, so there is relatively little demand for self-test kits.”

At present, according to the relevant documents of the State Food and Drug Administration, the rapid antigen kits will be mainly used in primary medical institutions, isolation and observation personnel and to meet the needs of personal testing. Antigen test is a supplement to nucleic acid test and is used for early triage and rapid management of suspected populations, but it cannot be used as the basis for the diagnosis of new coronavirus infection.

Nucleic acid testing in primary health care institutions is still the first choice, and antigen testing should only be performed when nucleic acid testing capabilities are not available. When the antigen test result is positive, the antigen-positive person should be transferred to a medical institution with a fever clinic for nucleic acid test.

Dr. Li Tongzeng, Chief Physician of the Department of Infectious Diseases, Beijing You’an Hospital Affiliated to Capital Medical University, Dr. Li Tongzeng also suggested that the preliminary antigen test “is best to be in the hands of medical institutions. Areas and sealed-off areas, antigen detection can be considered in the interval between two nucleic acid tests, but in the end, nucleic acid is still used as the standard for release from isolation.”

At the press conference of the Joint Prevention and Control Mechanism of the State Council held today, Li Jinming, deputy director of the National Health Commission’s Clinical Laboratory Center, said that antigen testing should be used in high-risk, high-prevalence patients The general population should not do antigen testing at will.

(Lin Meng, Jia Qin, Shi Qi, Wang Shu and Xue Hua are all pseudonyms)

Planning: yuu.

Producer: gyouza, Leu.

Image source: Visual China