On March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. Since then, five covid-19 antigen self-test products have been officially launched, of which two are developed and produced by Guangdong enterprises.
field test results
Covid-19 virus nucleic acid detection technology research and product development has always been one of the key directions of epidemic research in Guangdong Province. Last year, Guangdong made a multi-point layout to develop nucleic acid testing products, added 4 testing reagents and obtained the national medical device registration certificate, with a total of 14, the largest number in China.
Among the two Guangdong enterprises approved, Shenzhen Huada Yin yuan Pharmaceutical Technology Co., Ltd. (Hua Da Yuan), formerly known as Huada group, has been infected with a business team. It has been formed through the continuous cultivation of the SARS epidemic team in 2003.
According to WeChat official account of Huada medical science, in December 2020, the New Coronavirus antigen detection kit developed by Hua Da Yin developed the registration certificate of medical devices issued by the State Administration of drug supervision. The kit uses immunochromatographic sandwich method and fluorescent microspheres as tracer markers to detect covid-19 virus N antigen in oropharyngeal swabs and nasopharyngeal swabs of people suspected of covid-19 virus infection. The detection kit has the characteristics of high sensitivity, strong specificity, good stability and fast results.
At the end of last year, China’s vice president of Bgi Genomics Co.Ltd(300676) and Hua Da Yuan Yuan Chen Weijun, who delivered a keynote speech at the 2021 China Brand Forum, revealed that in order to meet the needs of simpler home self-test, New Coronavirus’s first New Coronavirus antigen detection kit developed by Bgi Genomics Co.Ltd(300676) could complete all tests within 15 minutes.
Another enterprise Guangzhou Wondfo Biotech Co.Ltd(300482) , whose full name is Guangzhou Wondfo Biotech Co.Ltd(300482) , was founded in 1992 and headquartered in Guangzhou Science City. According to previous reports, the covid-19 antigen detection kit developed by Guangzhou Wondfo Biotech Co.Ltd(300482) is one of the first covid-19 virus antigen detection reagents to obtain medical device registration certificate in China. At the same time, it has obtained the access qualification of EU CE and Latin America, the Middle East, Southeast Asia and other regions, and has been promoted for home self-test in Europe. At present, the product has been exported to 79.86 million people.
At the story sharing meeting of “Hong Kong supply guarantee, we support you” held in Guangzhou on February 16, Guangzhou Wondfo Biotech Co.Ltd(300482) senior vice president Kang Keren introduced that Guangzhou Wondfo Biotech Co.Ltd(300482) is one of the largest covid-19 antigen reagent manufacturers in China. At present, the enterprise has developed a variety of detection products, which can provide covid-19 detection products with the trinity of “nucleic acid PCR + antigen + antibody”.
Kang Keren said that the rapid detection of covid-19 antigen is easy to operate, has no special requirements for operators and does not depend on equipment. It can realize on-site detection and produce results in 15-20 minutes. “At present, Guangdong People’s Daily has launched the” rapid detection and application of vid-3002-co19 antigen “in the pilot of” Guangdong Provincial People’s daily and international co-3002 antigen prevention and control “. At present, the” vid-3002-co19 “antigen is under rapid application in Guangdong Province.” Kang Ke said.
can be used for early diversion and rapid management of suspected population
It is understood that antigen detection is directly aimed at the specific protein (i.e. antigen) in the virus. It can quickly detect whether the human body contains the virus in the acute infection period, provide direct evidence of virus infection, and operate simply and quickly. It can be used for early diversion and rapid management of suspected people.
According to China’s “covid-19 virus antigen detection application scheme (Trial)” released on March 11, in order to further optimize the covid-19 virus detection strategy, according to the needs of epidemic prevention and control, the comprehensive group of joint prevention and control mechanism of the State Council decided to promote the monitoring mode of “antigen screening and nucleic acid diagnosis”, and add antigen detection as a supplement on the basis of nucleic acid detection.
The scheme stipulates the applicable groups for antigen detection: first, those who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms within 5 days; Second, isolate observers, including those in home isolation observation, close connection and secondary close connection, entry isolation observation, sealing and control area and control area; Third, community residents who need antigen self-test.
It should be noted that nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection. As a supplementary means, antigen detection can be used for screening of specific populations, which is conducive to improving the ability of early detection. If the primary medical and health institutions have the ability of nucleic acid detection, nucleic acid detection shall be the first choice; Those who do not have the ability of nucleic acid detection can carry out antigen detection, and do a good job in the training of medical personnel and the communication and guidance of patients. When conducting antigen testing, isolation observers and community residents should carefully read the instructions and standardize the operation. Once the antigen test is positive, they should immediately report to the relevant departments; If necessary, conduct nucleic acid test for confirmation.
