The kit`s supply-side production is sufficient, not "in short supply ", but stuck in the Spring Festival capacity constraints, high threshold testing conditions, and the approval of the relevant drug qualifications. To this end, the State Drug Administration has recently opened a rapid approval channel.
Journalist|Yi Wong Yan Yan
New Year`s Eve: kit for 120,000 people
January 24, New Year`s Eve, Shanghai Xiaoyu. On Yindu Road, Huajing Town, Xuhui District, a figure could not be seen on the four-lane road. Turning into a park, I saw a building with lights on, and from a distance I saw a lot of people wearing masks, working together to assemble a box of boxes. The box was small, red and purple, and looked like a medicine box. Such a box is the key to the diagnosis of a new type of coronavirus pneumonia in Wuhan.
New coronavirus nucleic acid detection kit
The boxes are all "nucleic acid detection kits" to be sent to the Wuhan epidemic area, developed by Shanghai-based Geno Biotechnology, one of the three manufacturers and purchasers of kits that have been announced by the National Health and Health Commission. A box about the size of a smartphone for 50 people. On the rainy New Year`s Eve, Jeno`s staff told our journal, jornalist, that the company is working overtime, a total of 60-70 people, the day is expected to complete the production of 120000 people before work, sleepless can be more. The new type of coronavirus pneumonia epidemic is still spreading, in Wuhan, Hubei, Huanggang, Xiaogan and other places, the detection kit used for diagnosis is in a hurry, a large number of patients hovering outside the hospital door, cannot be diagnosed in time. In times of crisis, producers are working overtime to meet emergency needs. In addition to Shanghai Jiano, the National Health and Health Commission has confirmed Shanghai Berger and Shanghai Huirui as officially approved suppliers. "is destined to be an extraordinary New Year`s Eve, is destined to be an extraordinary year. "As New Year`s Eve approached, Wu Yong, Ph.D., Ph.D., University of Florida and technical director of Ningbo Hirsch Genetics Technology Co., Ltd., had a Timeline.photo in which employees discussed the test kit with PowerPoint in the conference room. Among the dozen people attending the meeting, each ordered a KFC take-out as a New Year`s Eve meal. Then a technician, dressed in protective clothing and wearing goggles and masks, entered the sterilization room. Hirsch is also one of the companies that can produce new coronavirus detection reagents. Wu Yong introduced that the clinical diagnostic kit production is a mature industrial system, there are a number of domestic companies that produce IVD nucleic acid detection kits. On december 8 last year, the first case was found in wuhan. On january 11th the research institute released genomic sequence information, and about 30 manufacturers developed a new type of coronavirus detection reagent within a week. Although the CDC recommends only a list of three companies, companies outside the list are also working overtime.
Very fast R & D and production progress, corresponding to the super high demand, from Wuhan as the focus of the country. A kit maker has revealed that kit shortages are not only in wuhan, but in coastal, southwest and other places, many hospitals and cdc systems have begun to stock up on kits for suspected cases. "We were prepared for thousands of people a day, and now the output may have to rise to tens of thousands a day. Mr. Wu said the company`s pace is extremely tight, with sales staff running at full capacity and upstream supply chain companies urgently starting to cooperate. Over the past week, Hirsch has provided tens of thousands of free test reagents to hospitals and CDC departments across the country. Kit companies are working overtime, but can meet the testing needs of Wuhan and Hubei? Several companies said the kit`s current production and capacity is by no means a problem. "We can supply Wuhan as much as it needs. Shanghai officials have said publicly that the company has now delivered about 150,000 people. Before New Year`s Eve, they passed the bus on the night of January 23," drove 20,000 people to the Wuhan city border, which was collected by the Wuhan CDC. "The staff member told the publication. Other companies have similar positions. The state commissioned the production of Shanghai Huirui Bio to the media, said they have produced a total of about 100,000 people of the kit, the daily output of 2-3 million people, the production end of the supply is sufficient. Jiangsu Shuoshi also said that the company is providing the market at a daily production rate of 100,000 people. "We don`t rest for the Spring Festival. Mr. Wu said the company will increase capacity at a later stage, as much as a million people a year. `If demand increases later, the company may run out of capacity to supply market demand,` he said. From the quantity of production supply, the kit is undoubtedly sufficient.
Threshold: High detection conditions
However, why have so many kits not been used in countless suspected patients? Logistics is a reason. Many kits need to be transported in cold chain, but during the Spring Festival, the capacity is tight, some products run overland, and some products are transported to all parts of the country by air by human flesh. the more important reason is that there is a high threshold to use the kit for testing and need to be equipped with relevant laboratories, instruments and technicians. "It doesn`t mean you can measure it anywhere with this box, no. "said one paramedic. According to the prescribed procedures, the kit will generally be sent to the provincial CDC, and then issued by the provincial CDC. A head of the cdc center in yunnan province told the journal jornalist that a new infectious disease virus should be managed in accordance with the state`s prescribed class a infection. To avoid contamination, testing should be done at least in laboratories that have reached biosafety level 2," probably not in most hospitals. "There must be negative pressure equipment in the testing laboratory, and the air flow can only be in and out; the cleanliness of the laboratory, the ventilation system and the disinfection and sterilization are all extremely high requirements. If conditions are not available for testing, the virus is likely to leak and the laboratory becomes a source of contamination. "It is now stipulated that personnel protection measures for third-level protection should be adopted in the environment of secondary protection. Wu said the requirement was high, meaning that only a third-class hospital could do the tests.
The problem is that Wuhan is currently treating suspected new patients with coronavirus pneumonia outpatient designated hospitals, mostly small and medium-sized hospitals, no test conditions. This is the "7 7" guarantee system adopted by Wuhan to deal with more and more patients, that is, to requisition 7 secondary public hospitals to do fever designated outpatient clinics, each designated hospital has a corresponding large general hospital to do counterpart help. In overcrowded designated hospitals to see a patient, need to help the hospital and even the CDC to do testing. In the designated hospitals wuhan red cross hospital, wuhan hankou hospital, medical staff said the hospital did not have kit and testing conditions, the hospital only reported high-risk suspected patients. "We only rely on the CDC to help us do it, only they have the conditions. "said a medical worker at the Red Cross Hospital. But in fact, many third-class hospitals do not have similar conditions. Doctors at the Nanjing Gulou Hospital (Sanjia) said its hospital laboratory failed to meet the standard for testing. A local doctor in Wuhan said," There are few hospitals in Wuhan that can do this. "It is understood that these testing conditions are mainly concentrated in Tongji, Concorde and provincial and municipal CDC. The labs are facing a shortage of staff as the outbreak erupted. And in other cities around Wuhan, the number of hospitals with testing conditions is even more limited, generally concentrated in the city-level large hospitals. Taking huanggang city as an example, according to our journal jornalist, there are only 1-2 of the relevant designated hospitals with testing conditions and equipment. This means that there are a large number of grass-roots hospitals in the whole city of Hubei do not have the conditions to test, for suspected patients outside the central city, the diagnosis is out of reach. A similar pattern exists in other parts of the country. A staff member of a local hospital in anhui province said there were few hospitals that could be tested." Basically, there are 37 hospitals with fever in anhui province. "
Emergency: Special access opened
On january 23, wuhan health and health commission said that since january 22, has designated designated hospitals for the treatment of fever, designated hospitals to help the hospital, as well as the city CDC and other qualified and grade laboratories to carry out relevant testing work. The first batch of 10 organizations are expected to be fully operational, with nearly 2,000 samples per day. Thirty thousand kits will be distributed to the designated testing bodies. This is Wuhan in order to "to meet the needs of the current situation of prevention and control, improve the speed of detection ", the results of the request to the superior. Before that, the case samples should be transferred from the CDC to the CDC, and then transferred to the CDC for testing, each day can detect more than 200 samples, the duration is generally around two days. Wuhan Health and Health Commission also revealed that before January 16, the entire Hubei province did not have a kit, need to be sent to the national designated agency, the result of the return of about 3-5 days. This is one reason why the number of confirmed diagnoses has soared since the 19th. It also reflects the current dilemma of the diagnosis: many hospitals do not have the ability to test, even if they are qualified. The hospital`s case samples were sent to the CDC for testing, and the results, which would have been available in a few hours, were extended to 2-3 days - according to national policy, the hospital is currently unable to purchase a new virus detection kit directly, only the CDC has a kit, which also led to a shortage of kit at the hospital end. The aforesaid head of disease control in Yunnan said that the kit will not be sent directly to the hospital. In xiaogan, the city`s third-class central hospital doesn`t have a kit, while the city`s first people`s hospital says the number of kits "comes from above, sometimes, sometimes not." "
Another practical dilemma is that for manufacturers, the kit supply hospital is required by the fdc registration certificate, but today any domestic manufacturers do not have the relevant qualifications. According to the normal process, if a nucleic acid detection kit from the start of research and development, to obtain a FDA registration certificate, generally take 3-5 years. It involves design, verification, product registration inspection, clinical experiment, registration approval of the State Drug Administration, etc., with long time and many processes. Currently, this process clearly does not meet emergency needs.
According to media reports, to this end, the State Drug Administration recently opened a rapid approval channel, launched an emergency review. A total of seven companies developed new coronavirus nucleic acid detection kits to enter the approval, including three previously confirmed supply companies. On January 24, Shanghai Zhijiang Biotechnology Co., Ltd. passed the inspection and became the first new type of coronavirus detection product approved by the statutory inspection organization in China. However, it only completed the inspection, has not been officially approved listing, the follow-up process has not been completed. however, the epidemic does not wait. With the spread of the epidemic, many manufacturers began direct supply to hospitals, sales staff phone is directly linked to the Internet for local government, hospitals, disease control consultation. Major kit makers began getting calls from some hospitals. "I can`t answer the phone. It`s like right every day. "said a staff member in Shanghai`s marketing department. "This is a special act of emergency. One insider said the 3-5 year period was shortened to about 15 days at the moment.
For some hospitals and patients," diagnosis "doesn`t mean anything, it`s just a number in the official circleanotice. Even this number needs to be confirmed by a second test and released uniformly. The medical staff of the hospital said they had quarantine boxes and all equipment, that is, the diagnosis should be issued uniformly by the Health and Health Commission. "(Journallist Yue Ying and Langer also contributed to this article)
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