In March 13th, the reporter learned from Bgi Genomics Co.Ltd(300676) that the SFDA issued a circular recently to approve the change of the registration certificate of the New Coronavirus Bgi Genomics Co.Ltd(300676) (2019-nCoV) antigen detection kit (fluorescence immunochromatography). The change of medical device registration certificate increases the scope of application of Bgi Genomics Co.Ltd(300676) covid-19 antigen detection products, which is applicable to professional medical institutions such as disease control and grass-roots hospitals or people who are “willing to be tested as much as possible” in isolation / containment areas, which means that specific people can buy Bgi Genomics Co.Ltd(300676) covid-19 antigenic products for self-test, which helps to meet the diversified detection scenarios of overall epidemic prevention and control.
Bgi Genomics Co.Ltd(300676) covid-19 antigen detection product.
Antigen detection is directly aimed at the specific protein (i.e. antigen) in the virus. It can quickly detect positive cases in the acute infection period. It can be used as a supplementary detection method for specific population screening, which is conducive to improving the ability of “early detection”, and plays an important role in optimizing covid-19 virus detection strategy and overall epidemic prevention and control.
It is understood that Bgi Genomics Co.Ltd(300676) New Coronavirus (2019-nCoV) antigen detection kit (fluorescence immunochromatography) using immune chromatography sandwich method, combined with fluorescent microspheres as tracer markers, suspected COVID-19 virus infection of human throat throat swabs, nasopharyngeal swabs samples of COVID-19 virus N antigen detection.
Bgi Genomics Co.Ltd(300676) said that the test kit product needs to be adapted to the dry fluorescence immunoanalyzer. The test results have high stability and specificity, can realize rapid detection, and has the advantages of automatic interpretation of test results and information management of test samples.
According to Bgi Genomics Co.Ltd(300676) information, the sensitivity of the detection kit product is about 10 times higher than that of the traditional colloidal gold chromatography detection technology, and the results are automatically interpreted by dry fluorescence immunoanalyzer, which can achieve zero manual error. In addition, the product can be connected to the hospital LIS system (hospital inspection management system) to realize information-based management of test samples.
In terms of the dry fluorescence immunoanalyzer equipped with the product, the instrument is small and easy to carry. It is suitable for a variety of detection scenarios such as customs, airports, schools, hospitals, cruise ships, clinics, township health centers, business units and CDC; Equipped with a 4.3-inch high-sensitivity touch LCD screen, a reagent strip socket, supporting Bluetooth or wireless network data transmission of test results, information management of all test specimen information and traceability information; It can realize 15 minute rapid detection, and can carry out multiple sample rapid tests continuously. One instrument can read at least 60-100 sample results in one hour.
Bgi Genomics Co.Ltd(300676) said that the product has the advantages of simple operation, fast detection, no specific laboratory environment and no complex detection equipment. It is especially suitable for rapid screening and diversion management of people.
Bgi Genomics Co.Ltd(300676) covid-19 antigen detection product detection process.
In terms of applicable population, Bgi Genomics Co.Ltd(300676) introduces that first, the personnel who go to grass-roots medical and health institutions with respiratory tract, fever and other symptoms within 5 days; Second, isolate and observe personnel, including personnel 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.
Bgi Genomics Co.Ltd(300676) at the same time, it is reminded that if the grass-roots medical institutions do not have the ability of nucleic acid detection, they 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 detection, isolation observers and community residents shall carefully read the instructions and standardize the operation. Once the antigen test is positive, it shall be reported to the relevant departments immediately and confirmed by nucleic acid test.
