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China'S Kit Launch: Global Epidemic Spawned Demand Disruption And Transportation As The Biggest Obstacle

2020/3/28 10:03:00 0

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With the spread of the new crown pneumonia epidemic, the demand for the new crown virus detection kit has increased significantly. Detection becomes the key to control the epidemic situation. In the case of overseas Multi Country epidemic and shortage of kits, some analysts believe that the spring of Chinese reagent box enterprises has arrived.

Liu Ping, the founder of Boao Seth Biotechnology Co., Ltd., who produced the test kit in March 23rd, told an economic reporter in twenty-first Century that China provides valuable experience for the world's epidemic prevention. Chinese diagnostic reagent enterprises have rich clinical experience and have great advantages in terms of cost.

According to the twenty-first Century economic report reporter from the State Food and drug administration, there are 23 new crown pneumonia detection kits approved, and a number of enterprises have been certified by the European Union and exported to many countries. "Pandemic" has brought pressure to the diagnostic reagent industry as a whole. Affected by the epidemic, other testing businesses besides the new crown virus have been greatly affected. But it does bring some new businesses to companies that are capable of developing and producing new crown pneumonia detection reagents. Liu Ping said.

However, according to the twenty-first Century economic news reporter recently, from the courier companies, airlines and related kits exports, and other ways to understand, China's local reagent box enterprises are facing many problems in the sea, for example, during the special period, exporting countries require strict supply of various documents. At present, the biggest problem is transportation. Because of the need to prevent and control the epidemic, most of the international air lines are suspended or reduced, and the transportation of products and the specific transportation time are all affected.

Detection is the key to epidemic prevention.

Judging from the current situation of war epidemics in various countries, countries with better detection can better control the epidemic situation. As an early outbreak of the disease, South Korea has achieved good results in epidemic prevention, without stopping the work and in the normal life of ordinary citizens. One of the experiences is extensive detection.

According to reports, the number of coronavirus detected in South Korea has exceeded 300 thousand, far exceeding that of other countries, which makes many people can be isolated and treated shortly after infection. South Korea's foreign minister, Kang Jing, points out that detection is crucial because it can detect cases early, minimize further threats, and quickly treat people infected by the virus.

Xiao Jin, a pseudonym in Seoul, Korea, introduced to the economic news reporters in twenty-first Century 26 days ago that there were many flow detection (nucleic acid detection kit multiplex fluorescent RT-PCR method) in South Korea's streets.

Zhang Sai, head of the Seoul University of Korea and director of a public welfare organization, told the twenty-first Century economic news reporter that the detection rate of nucleic acids in South Korea's sites was very high, which played a great role in controlling the epidemic situation.

Because of the urgent need to use diagnostic reagents and other medical devices for fear of a pandemic, as early as the end of 1, the Ministry of disease management and food and drug safety department of the Republic of Korea began to apply for the new application system for the urgent application of new crown pneumonia diagnostic reagent. If there is no domestic licensed product or insufficient supply, the system can be exempted from the product licensing stage, and the manufacturing (import), sale and use system is limited. So far, South Korea has approved 5 detection kit products.

After many efforts, the number of newly added cases in Korea is about more than 100, far below the peak period of 909 cases.

In stark contrast, Italy is far from adequate in terms of detection.

Recently, China's second batch of heads of Italy anti epidemic medical expert group and Qiu Yunqing, executive vice president of the First Affiliated Hospital of Zhejiang University medical school, said that the detection reagent and personnel in Italy were not enough. Many people failed to detect and found no source of infection. Many close contacts and even patients in the community and crowd were not well controlled. The problem.

Many countries have also found the importance of testing and filling gaps in different ways.

On March 16th, the FDA issued the guidance policy on the registration and listing of new crown virus detection products in public health emergency, which mainly directed enterprises to apply for EUA (Emergency Use Authorization, emergency use authorization). EUA is a temporary "pass" for listing. After the announcement of the outbreak of FDA, products with EUA qualification can no longer be listed for public registration. Recently, Perkin Elmer new crown virus nucleic acid detection kit was approved under this background.

According to China news service, health minister Matt Hancock announced in March 24th that Britain had urgently purchased 3 million 500 thousand new crown virus antibody test kits and expanded the number of tests. British Prime Minister Boris Johnson has said he hopes to improve the detection capability as soon as possible and test 25000 people a day. According to the published data, in fact, the UK does not test more than 8400 cases per day.

British media said that medical experts analyzed and speculated that the number of new crown virus infected people was tens of times lower than that of the actual situation because of the fact that the patients with mild diseases were not detected. The actual number of new crown virus infected people in Britain is probably around 300 thousand.

Reagent box opportunities brought by overseas epidemic

"The important role of detection reagents in the control of epidemic situation, the increasingly severe epidemic situation overseas, and the serious shortage of reagent kits in various countries, all need the rapid response of Chinese diagnostic reagent enterprises to overseas demand." Liu Ping said.

The shortage of nucleic acid test kit will become a global problem, and the demand for high efficiency kit produced in China is expected to remain high, Huaxi Securities reported that 500 thousand to 700 thousand of the global daily consumption of nucleic acid detection kits.

According to research reports, at least 26 countries in the world have submitted supply orders to China, and the number of kits is over 15 million.

In fact, China has provided many valuable experiences to the global epidemic prevention, such as publishing the whole genome sequence of the new crown virus, sharing the epidemiological characteristics of the new crown pneumonia epidemic situation, prevention and control strategy, clinical diagnosis and treatment, and close tracking.

For example, the Perkin Elmer nucleic acid test kit approved by the United States was a quick response from the Chinese team of Perkin Elmer in the early days of the outbreak of China. For the first time, a new crown virus nucleic acid detection kit (PCR- fluorescent probe method) was developed for the detection of blood and various respiratory samples.

In March 25th, Perkin and Elmer, who were responsible for the report of the twenty-first Century economic report, said that the new Suzhou Bio Technology Co., Ltd., which had been exported to the United States, had exported a number of newly developed crown nucleic acid detection kits to Perkin Elmer laboratories in the United States, and the kit was waiting for approval by the China pharmaceutical regulatory agency.

Feng Luzhao, a researcher at the China Center for Disease Control and prevention, pointed out that the current approved new crown pneumonia detection reagents mainly include two categories, one is nucleic acid test reagents, the other is antibody detection reagents.

Among them, the first type of nucleic acid detection process includes sample processing, nucleic acid extraction, PCR detection and many other steps. The average detection time takes 2-3 hours. Because it is a direct detection method for virus nucleic acid in collection specimens, it has high specificity and high sensitivity.

Second kinds of antibodies were detected, including colloidal gold method and magnetic particle chemiluminescence method. The average detection time of colloidal gold method is about 15 minutes. Magnetic particle chemiluminescence method usually takes 30 to 60 minutes.

According to the twenty-first Century economic report reporter from the State Food and drug administration, as of March 27th, the official website of the State Food and Drug Administration announced in March 27th that it approved 15 new crown nucleic acid detection kits, and 8 antibody detection kits.

Among them, more than 10 enterprises have completed the EU CE certification, which is sold to the European Union and other regions. In March 17th, KELONG bio announced that its new crown virus nucleic acid reagents and 3 antibody detection kits received the free marketing certificate of the EU market, and had completed the registration of the EU authorities and qualified the EU market. In March 25th, the 2019-nCoV coronavirus nucleic acid detection kit (fluorescent PCR method) was approved by the European Union CE. Officially obtained the qualification to enter the EU market.

In addition, the Chinese big gene announced in March 19th that the new coronavirus nucleic acid detection kit product has launched the FDA declaration of the US EUA. In March 27th, the twenty-first Century business reporter learned from the Chinese big gene that the kit became the first authorized product of the US FDA emergency use in China. Prior to this, the nucleic acid test kit produced by the European medical company, a wholly owned subsidiary of Huada gene, has completed the CE certification of the European Union.

Liu Ping introduced that different countries need different qualifications. For export to the European Union, ISO13485 system certification and CE product certification are needed. CE product certification is basically recognized in most countries and regions except the United States.

Chaos and chaos

Although overseas outbreaks are an opportunity for Chinese diagnostic enterprises, especially kit business, there are also some problems.

Liu Ping analyzed the twenty-first Century economic report reporter, from the market feedback, Europe and the United States and other countries in the use of kits there are some problems. The use of colloidal gold antibody detection kit for residents at home is more. Because of the large demand, the related export volume in China is also large.

"This may be related to the guidance of overseas media, and everyone should be self tested. But this is not very meaningful. Because individuals have not been trained, they are not professional and non-standard, and can not be sure whether there is enough blood. If the sampling is unqualified, it is impossible to detect the exact results, and the sensitivity of whole blood detection is low. Serum detection is much more sensitive than whole blood detection. Liu Ping pointed out.

In addition, Liu Ping was very worried about the disposal of the test paper after the test. He cautioned that medical waste and improper handling of blood may cause pollution, especially if it is positive and infectious. Specialized laboratories should inactivate these wastes. Therefore, "it is recommended that there is a need or a professional medical institution and a doctor to do the tests."

An agent also confirmed Liu Ping's analysis. "Now there are many foreign countries looking for our kit to buy colloidal gold antibody detection kit. The overseas market is rather confusing. There are many people who call to consult every day, there are both genuine and fake ones, and others are just passing our price. "

At the same time, there are also some cases of illegal exports in troubled waters. Spanish media reported that 9000 new crown virus detection kits were imported from Yi Rui biology in Shenzhen, and the official detection rate was only 30%. Spanish officials have informed the matter. The Chinese ambassador to Spain issued a statement that the company did not receive any qualification, including the China National Drug Administration and the European Union CE certification. According to the twenty-first Century economic report reporter, in March 27th, the Shenzhen market supervision department has launched a quick verification of it.

The director of research and development of a gene testing company pointed out to the twenty-first Century economic news reporter that there is no authoritative data on the accuracy of the detection reagent in the country. There is no formal evidence for the so-called nucleic acid kits detection rate of 30% to 50%. If the accuracy rate is too low, the China drug administration will not approve it.

The researchers and Liu Ping agree that nucleic acid detection and antibody detection can improve accuracy. Liu Ping pointed out that as a detection method, antibody detection has been clearly written into the notice issued by the national health and Health Commission's office on the prevention and control of new coronavirus pneumonia (Seventh Edition).

An insider, who declined to be named, pointed out to the twenty-first Century economic news reporter that this is part of China's public health to the sea. The primary premise is that products and technology go through the border and stand up for inspection. "It is not simply to go out to sea, but also to take care of its own field."

Logistics transportation is the biggest obstacle

For Chinese reagent kits, the biggest problem in the overseas market is transportation.

With the grim situation of the epidemic, foreign imports of anti epidemic materials are also more stringent. According to the introduction of Shun Feng customer service, different countries have different requirements.

For example, the United States requires commercial anti epidemic materials to enter the United States under the supervision of FDA, which requires FDA related information, and manufacturers and the receiving party need to have relevant qualifications. Among them, the manufacturer should have the registration number of equipment manufacturer abroad and the list number of equipment. At the same time, it also requires the importer to have initial importer registration and medical device / facility registration.

The UAE requires the recipient company to provide a copy of the trade license and obtain an import hygiene permit (MOH) in the UAE Ministry of health.

The import of commercial sales purpose is required by Korea to pay 10% customs duties and 10% value-added tax. Importers need to submit standard clearance reports to the Korea import and Export Association. When importers first import such articles, they need to obtain relevant licenses; the application license requires the following qualifications: A. has import qualification; B. has warehouses for goods custody; C. has self quality testing. Prepared; D. has no record of being punished for breaches.

Another person who refused to be named was told by the twenty-first Century economic report reporter that although some customs offices had opened a green channel, the efficiency of customs clearance was particularly low. "Now many countries are in a state of emergency, some flights are grounded, and the flight resources are tight, including the large volume of exports, which will be extended on the original basis."

Due to the need of epidemic prevention, a large number of flights are grounded, and the shortage of transport capacity has brought inconvenience to the export of the relevant kit enterprises, and has also pushed up the logistics cost.

A person in charge of the enterprise said that most of the nucleic acid detection kits need cold chain transportation. Only DHL can transport Italy, but DHL company stipulates that it can not use dry ice. SF EXPRESS said in March 23rd that due to the cancellation of some international flights in recent years, the shortage of resources on International routes led to the rise in costs. SF EXPRESS international temporarily charged peak resource adjustment fees.

It is understood that, in order to ease the pressure of shortage of freight capacity, many foreign airlines even use passenger planes to carry out cargo transportation. For example, the Eastern Airlines technology company carried out an urgent modification of two A330 aircraft, and disassembled 120 groups of 316 cabin seats in 48 hours. In the early morning of March 24th, a number of emergency medical supplies were transported to Prague, Europe.

 

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