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Source: http://www.bjnews.com.cn/news/2020/01/24/679052.html

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News Live Comment Depth Finance More
2020-01-24 20:06:29 Beijing News Reporter: Xu Wen Editor: Chen Si
New Coronavirus kit has sufficient production capacity but encounters transportation difficulties

Due to the urgency of the epidemic, companies that have developed kits have not yet obtained formal registration qualifications.

The Beijing News (Reporter Xu Wen) The epidemic of new coronavirus pneumonia is still ongoing, and there is news that the hospital’s test kit is urgent, causing patients to be unable to confirm the diagnosis in time. According to the Beijing News reporter, not all hospitals have the qualifications to use test kits. At present, many biological companies are expediting the production of kits, but there are difficulties in the transportation of kits.

Expedited production by many companies

A nucleic acid detection kit for detecting a new coronavirus is an important tool for determining whether a patient is infected.

The reporter combed and found that on January 10, the new coronavirus gene sequence was announced to the public, and many companies announced the development of test kits. Among them, Shanghai Genuo (hereinafter referred to as Shanghai Genuo) affiliated to Sinopharm China Biological is the first company to successfully develop a test kit.

On January 13, Soworld Biotech announced that after 3 days of overnight research and development, the development of a new coronavirus nucleic acid detection kit was completed. On January 15, BGI announced that its subsidiary Shenzhen BGI Yinyuan Pharmaceutical Technology Co., Ltd. has successfully developed a test kit.

On January 20, Kehua Biological announced that Tianlong Technology, a subsidiary of the company, urgently tackled the development and production of test kits. On the same day, Shengxiang Bio announced that the kit was successfully developed in only 72 hours, and the test results can be obtained in as short as 30 minutes. On the same day, Daan Gene confirmed in an interview with the media that the company has developed a kit.

On January 22, Xilong Science responded to the Shenzhen Stock Exchange’s attention letter and stated that its subsidiary Icway Bioassay Kit had been listed.

From the information released by various companies, there is currently sufficient production capacity of test kits. Wu Qingyi, the secretary of the company, said in an interview today that the company is providing the market with a production rate of 100,000 copies per day. The relevant person in charge of Shanghai Jeno also told the media today that according to the calculation that each kit can be used for 50 people, the current production volume of the kit can be used for tens of thousands of tests.

Most logistics have stopped shipping, transportation becomes a new problem

Although many biotechnology companies have successfully developed kits, the “National First Provincial Coronary Virus Infection Pneumonia Case Confirmation Procedure” issued by the National Health and Medical Commission only circled the kits of three companies to choose from.

The above documents mentioned that the provincial CDC nucleic acid detection kits can be selected from three companies: Shanghai Pharom Biotechnology Co., Ltd., Shanghai Genuo Biotechnology Co., Ltd., and Shanghai Berger Medical Technology Co., Ltd.

Kobayashi (pseudonym), a sales person responsible for the supply of a new coronavirus kit from a biological company in Hubei, told reporters that there is no technical difficulty in developing the kit. Many companies have successfully developed the virus gene sequence within a short period of time after the virus gene sequence was announced. Only three companies were named in the first document of the Health Commission, so the disease control department could only go to these three companies for procurement, and the output naturally could not keep up. “Some people with disease control responsible for procurement took cash and went to the door of these three companies to squat Wait for the kit. “

Due to the urgency of the epidemic, all companies that have developed kits have not yet obtained formal registration qualifications. Kobayashi told reporters that the registration process of the kit is complicated, and it normally takes two to three years to obtain formal registration qualifications.

Since January 22, the National Health and Medical Commission has repeatedly revised many documents such as the prevention and control of new-type coronavirus pneumonia, and the diagnosis and treatment plan, and has not made recommendations to the test kit vendors. Since then, the procurement of kits everywhere is not limited to three companies. The reporter was informed that many biological company kits have been supplied to the disease control centers of many provinces and cities nationwide.

But delivery has become a new challenge. Wu Qingyi said that since most of the logistics had been suspended before the Spring Festival, the company’s sales staff basically adopted the personal delivery model.

For blocked areas, the detection kit is even more difficult to access. Kobayashi told reporters that after the Wuhan access corridor was closed, the kits could not enter Wuhan. Yesterday, colleagues of the company took thousands of human kits and took them to Wuhan.

Daily testing samples will be increased from 200 to 2000

The kit can give test results within 3 hours, but a case is not diagnosed so quickly.

According to an official report, from January 16 to January 22, the process of detecting suspected cases in Wuhan is as follows: the first diagnosis of the hospital through standardized pre-diagnosis, combined with clinical examination, laboratory examination and chest imaging examination; After the consultation, suspected cases were confirmed and sampled. The disease control center of the jurisdiction transferred the samples to the city’s disease control; the city’s disease control center transferred to the provincial disease control center for nucleic acid testing. The provincial CDC can detect more than 200 samples every day. It takes about 2 days from the start of sampling to the return of results.

Why not send a kit to the hospital for direct testing? In fact, not all hospitals have biosafety labs that meet protection requirements.

According to China’s “Infectious Diseases Prevention and Control Law”, since the country has incorporated the new type of coronavirus pneumonia into the Class B infectious diseases, adopting Class A management, the detection of samples of this type of pathogens is managed according to highly pathogenic pathogenic microorganisms, and the relevant samples are tested and transported It must meet the relevant requirements of biosafety management, and pathogen-related experimental activities should be carried out in a biosafety laboratory with the corresponding protection level.

Waiting for the disease control department to issue a test result, will it affect patient treatment? A person familiar with the Wuhan medical system told reporters that at present, doctors at hospitals in Wuhan that receive fever patients at selected sites through consultations, combined with lung CT and other test results, even if there is no test result from the kit, can basically determine whether the patient may be infected with the new coronavirus. , And be treated in accordance with the corresponding diagnosis and treatment process.

However, the official number of confirmed cases depends on the test results of the kit. According to the National Health and Medical Commission monitoring program, nucleic acid testing is an important step in the diagnosis of suspected cases of new coronavirus pneumonia.

On January 18 and 19, Wuhan reported a sudden increase in the number of confirmed cases. One of the reasons was that for the first time on January 16, a test kit was obtained from the National Center for Disease Control and Prevention and a nucleic acid test was performed on suspected cases.

The reporter learned from the Wuhan Municipal Health and Health Committee that, starting on January 22, Wuhan has designated some hospitals and municipal disease control centers and other biosafety laboratories with corresponding protection levels to carry out the detection of pathogenic nucleic acids in related samples. The first batch of 10 institutions is expected to be fully operational. It can detect nearly 2,000 samples per day. It is planned to urgently transport 30,000 copies of kits to the designated testing institutions. At present, 6,000 copies have been distributed.

With the continuous distribution of 30,000 kits, it is still unknown whether the number of confirmed patients will increase significantly.

Beijing News reporter Xu Wen

Edit Chen Si