Blockbuster丨SARS-CoV-2's antigen detection reagent was successfully approved in China!
With the introduction of the SARS-CoV-2 self-test policy, the comprehensive group of the joint defense mechanism of the State Council recently decided to add antigen testing as a supplement on the basis of nucleic acid testing, and organized the formulation of the "SARS-CoV-2 Antigen Testing Application Plan (Trial)".
On April 1, 2022, the SARS-CoV-2 (2019-nCoV) antigen detection kit (colloidal gold method) developed by Nanjing Synthgene Medical Technology Co., Ltd. was approved by the State Food and Drug Administration (Registration Certificate No.: National Machinery Note 20223400427) and officially launched. Contribute to the rapid screening of the SARS-CoV-2 and the fight against the SARS-CoV-2 epidemic!
The kit adopts the double-antibody sandwich method to qualitatively detect the N-antigen of the SARS-CoV-2in human nasal swab samples in the form of solid-phase immunochromatography. Low. The SARS-CoV-2 antigen test is suitable for non-professionals outside medical institutions to use (self-test), and can detect the original virus strain and any variant of concern (VOC) including Omicron.
The SARS-CoV-2 antigen detection kit approved by Synthgene this time determines whether the subject has a new type of coronavirus infection by testing the nasal swab of the subject. Both in terms of simplicity of operation and accuracy of results, it better meets the current needs for SARS-CoV-2 detection. In the global epidemic prevention and control, Synthgene's SARS-CoV-2 antigen rapid detection reagent has become a powerful detection tool. Previously, this product has obtained the EU CE, EU HSC common list whitelist, and has been approved in Germany, France, Portugal, Ukraine, The Netherlands, Spain, Lithuania, Japan, Malaysia, Indonesia, Belgium and other countries and regions have obtained access qualifications, and at the same time entered the Phase 2 evaluation of the NIBSC institution in the UK! After multiple verifications by authoritative institutions in many countries, the multi-dimensional proof of the excellent product performance and good user experience of Synthgene's SARS-CoV-2 antigen detection.
With the popularization of the domestic model of "antigen screening + nucleic acid diagnosis",Synthgene's SARS-CoV-2 antigen detection kit will fully cooperate with the national SARS-CoV-2 detection strategy, improve the ability of "early detection", and actively develop the awareness of "early reporting" among the masses. Help the country and regions to speed up the response to the epidemic prevention and control, and contribute to the prevention and control of the epidemic!
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