On March 12, Shenzhen BGI Issued an Announcement on the Change of Medical Device Registration Certificate for New Coronavirus Antigen Testing Products of Its Holding Subsidiary BGI. According to the announcement, the change of the medical device registration certificate of BGI's new crown antigen testing products is mainly based on the relevant national regulations such as the "New Coronavirus Antigen Detection Application Plan (Trial)", and the expected use, instructions, storage conditions and product validity period of the product have been changed.
A day ago, the National Health Commission released a message saying that in order to further optimize the new crown virus detection strategy, the comprehensive group of the joint prevention and control mechanism of the State Council decided to add antigen detection as a supplement to the nucleic acid testing. The first batch of five new crown antigen self-test products approved by the State Food and Drug Administration include BGI ingenic products.
"This also means that specific groups of people can purchase BGI ingenic antigen products for self-testing, which is conducive to the diversification of testing scenarios for epidemic prevention and control." The relevant person in charge of BGI Gene said.
It is understood that the BGI Antigen Detection Kit (Fluorescence Immunochromatography) of the Novel Coronavirus (2019-nCoV) adopts the immunochromatography sandwich method, combined with fluorescent microspheres as a tracer marker, to detect the new coronavirus N antigen in the oropharyngeal swab and nasopharyngeal swab samples of people suspected of being infected with the new coronavirus.
"The tester needs to put the oropharyngeal swab and nasopharyngeal swab into the sample extraction tube, dissolve it well, and then remove the swab. The sample is then added dropwise to the sample well of the strip, and the test result can be determined after 15 minutes. The relevant person in charge of BGI Ingenu introduced.
So, who is the product for? According to BGI, the first is to go to the primary medical and health institutions for treatment, accompanied by respiratory tract, fever and other symptoms and symptoms within 5 days; followed by isolation and observation personnel, including home isolation and observation of close and sub-close contact, entry isolation observation, sealing and control areas and control areas, as well as community residents with antigen self-testing needs.
Antigen detection is a test that directly targets the unique protein (i.e., antigen) in the virus, can quickly detect positive cases during the acute infection period, and can be used as a supplementary test for screening specific populations, which is conducive to improving the "early detection" ability and plays an important role in optimizing the detection strategy of the new crown virus and the overall epidemic prevention and control.
It is worth noting that the BGI Antigen Detection Kit for the Novel Coronavirus cannot be used alone for the diagnosis of novel coronavirus infection, and should be combined with other diagnostic information such as nucleic acid detection and imaging, as well as medical history and contact history to determine the infection status. "A positive result can be used for early triage and rapid management of suspected populations, but a positive result only indicates the presence of a novel coronavirus antigen in the sample and cannot be used as a basis for confirming the diagnosis of novel coronavirus infection." Positive and negative antigens in suspected populations should be tested for further nucleic acid testing. The above-mentioned person in charge said.
[Reporter] Zhang Xiujuan
【Author】 Zhang Xiujuan
【Source】 Southern Press Media Group South + client