Wuhan'S Frontline Of Wistar Gene: Expanding The Capacity Of Kit To Solve Urgent Problems

The kit is the top priority for the diagnosis of new coronavirus. For the detection of the new coronavirus, the most important method is to detect the genetic material of human body (sputum, blood and bronchoalveolar lavage fluid), so as to confirm whether it is infected by the virus.

In the evening of January 26th, the State Drug Administration started the emergency examination and approval process, and only 4 days approved four kits of four companies. Among them, the Chinese gene was used to deal with the new pneumonia epidemic in Wuhan. As the three category of medical devices, test kits are generally required for clinical trial and approved by the State Food and drug administration before they can officially go public, get the opportunity to hang up the Internet, and enter the hospital for sale. This takes time in an annual unit. And the State Food and Drug Administration opened a green channel, greatly reducing the approval process.

According to the January 29th news broadcast report, the company approved by the State Administration of food and Drug Administration (Chinese big gene) has donated 100 thousand new coronavirus kits for Hubei province. For the production of kits, the next challenge will be the improvement of laboratory and testing capabilities.

It is understood that as of now, 53 enterprises have jointly initiated, willing to suspend part of the ongoing scientific research and business operations, and provide dozens of sites for PCR, laboratory, P2 laboratory and CAP certification laboratory for anti epidemic and anti poisoning. Automatic nuclear acid meter, automatic capillary electrophoresis apparatus, sequencer, PCR instrument, nearly 100 sets, testing kits, professional personnel and donations of tens of millions of yuan, covering 18 provinces and municipalities in Beijing, Hubei, Liaoning, Guangdong, Zhejiang, Jiangxi, Fujian, Shanghai, Heilongjiang, Tianjin and so on.

In January 25th, Wang Jian, the chairman of Huada gene, took the leading gene technician of China to Wuhan to support relevant work. In February 2nd, the economic report in twenty-first Century connected Chen Weijun, general manager of Shenzhen Hua Da Yin yuan Pharmaceutical Technology Co., Ltd., a subsidiary of Huada gene in Wuhan.

Economic report twenty-first Century (hereinafter referred to as twenty-first Century): according to your understanding of the current number of hospitals and research institutions in Wuhan is the ability to diagnose?

Chen Weijun: the first 13 health care, medical, and third party organizations announced by the Wuhan Municipal Health Protection Committee have the ability to test. With further organization and implementation and support, more and more institutions with the ability to check up should be mentioned. Because of the infectious diseases that are managed by class A, the accurate diagnosis institutions should comply with the requirements of the Health Council for the diagnosis of the new coronavirus.

Twenty-first Century: what are the main aspects of Huada's work in Wuhan? What is the capacity of the kit?

Chen Weijun: at the beginning of January 2020, the Chinese big gene began to develop the relevant kit with regard to the urgent organization of research and production forces. After ensuring the stability and accuracy through strict kits production process and quality control, in January 14th, official development of the 2019 new coronavirus nucleic acid detection kit (RT-PCR fluorescence probe method) was officially announced. The new coronavirus nucleic acid detection kit can be used for rapid identification and identification of suspected patients, and assist disease control departments and medical institutions to take timely and effective prevention and control measures.

With the development of the epidemic, after the development of the kit, more production forces were produced at the first time, and more kits were produced for epidemic prevention and control. At present, the kit has been used and stored in some disease control departments and hospitals, and the disease control and clinical evaluation are positive. At the same time, the delivery team of three pathogens in Wuhan, Shenzhen and Tianjin is always on standby. At the same time, a new coronavirus nucleic acid detection result can be issued in about 3 hours, providing the fastest information feedback for epidemic prevention and control.

In January 26th, the State Administration of pharmaceuticals for emergency examination and approval passed 4 new coronavirus products from 4 enterprises. Among them, Huada group's Huada gene and Hua Dazhi made 2 products of 2 companies, the new coronavirus detection kit and DNBSEQ-T7 sequencing system. Both of them formally passed the State Food and Drug Administration's emergency examination and approval procedures, and became the first batch of products that were officially approved for listing.

After several days of emergency production, Huada has completed the production of a new coronavirus detection kit for about 300 thousand people, greatly alleviating the supply pressure of the kit. At the same time, it has continued to urgently arrange for the production of 300 thousand people's kit and the new 300 thousand person kit.

Twenty-first Century: how big is the gap between inspection machines and inspectors? Is it necessary to speed up the speed of diagnosis in Wuhan?

Chen Weijun: because we do not have accurate data of suspected cases, we can not judge how big the gap is, which can only provide personnel and material support for the inspection area.

Twenty-first Century: there is a clinical case that reflects the negative conversion of Yang after repeated tests. Does this mean that there is a certain situation of error detection? Does this cause the efficiency of inspection work reduced?

Chen Weijun: in this case, it is possible that there is sampling error. The deviation caused by this situation may still exist. Two, the products that enter the market before the approval of the state pharmaceutical supervision department may vary in standards. With the approval of the State Administration of pharmaceutical products, the qualified products will enter the market in a large scale, and this possibility will be reduced.

Twenty-first Century: is the kit approved by the FireWire facing the challenge of rising false positive probability?

Chen Weijun: the principle of the state drug administration emergency examination and approval is that the procedures are accelerated and the standards are not lowered.

Twenty-first Century: how to ensure the successful delivery of the kit to Wuhan?

Chen Weijun: at present, the country has opened a special logistics channel, raw materials can be sent to Wuhan from all over the country, and Huada itself has the production base of reagent kits in Wuhan. It has great geopolitical advantages and can rapidly and large-scale supply the whole province of Wuhan and Hubei.