Synthgene Medical| Home self-test OTC hot hits are coming!


Release time:

2022-04-04

On April 1, 2022, SARS-CoV-2 (2019-nCoV) antigen detection kit (colloidal gold) developed by Nanjing Synthgene Technology Co., Ltd. (“ Synthgene”), a wholly-owned subsidiary of Jiangsu Synthgene Biotechnology Co., Ltd. Law) obtained the "Medical Device Registration Certificate" issued by the National Medical Products Administration (NMPA).

On April 1, 2022, Nanjing Synthgene Medical Technology Co., Ltd. (hereinafter referred to as "Synthgene"), a wholly-owned subsidiary of Jiangsu Synthgene Biotechnology Co., Ltd., developed the SARS-CoV-2 (2019-nCoV) antigen detection kit (colloidal gold method) and obtained the Medical Device Registration Certificate (registration number: National Machinery Specification 20223400427) issued by the State Drug Administration (NMPA).

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The kit adopts the dual antibody sandwich method to qualitatively detect the SARS-CoV-2 (2019-nCoV) N antigen in human nasal swab samples in the form of solid phase immunochromatography, which is fast diagnosis, convenient to operate, and relatively low requirements for equipment and personnel for nucleic acid detection. It is mainly suitable for non-professionals outside medical institutions to use (that is, self-testing), and can achieve good detection effect on various VOCs such as the original strain, Alpha strain, Beta strain, Delta strain, Omicron strain, etc.

SARS-CoV-2 (2019-nCoV) antigen detection kit (colloidal gold method) multi-specification display

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此次申基医药获批的新型冠状病毒抗原检测试剂盒通过检测受检者鼻拭子以确定受检者是否存在新型冠状病毒感染。无论是从操作的简便性和结果的准确性上,都更加满足当前新冠病毒检测需求。在全球疫情防控中,申基医药新型冠状病毒抗原快速检测试剂成为强有力的检测工具!

The SARS-CoV-2 antigen test kit approved by  Synthgene is used to determine whether the subject has a  SARS-CoV-2 infection by testing the subject's nasal swab. Whether it is from the simplicity of operation and the accuracy of the results, it is more in line with the current needs of SARS-CoV-2 testing. In the global epidemic prevention and control,  Synthgene SARS-CoV-2 antigen rapid detection reagent has become a powerful detection tool!

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Previously, the product has obtained the EU CE, EU HSC common list whitelist, and in Germany, France, Portugal, Ukraine, the Netherlands, Spain, Lithuania, Japan, Thailand, Peru, Belgium and other countries and regions to obtain access qualifications, through the multiple verification of authoritative institutions in many countries, multi-dimensional proof of  Synthgene SARS-CoV-2 antigen detection excellent product performance and good user experience.

 

 Synthgene OTC home self-test product line

At present, the Synthgene OTC home self-inspection product line has covered infectious disease testing, drug testing, women's health and other fields.

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申基医药OTC居家自检产品线

 

毒品类 

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传染病系列

 

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宠物健康

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食品安全

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胃肠类

 

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妇女健康

 

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优生优育

 

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心肌类

 

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