TopMed Laboratories novel coronavirus (COVID-19)IgG/IgM antibody detection kit (color microsphere method) has been CE certified, and is the first COVID-19 antibody detection reagent in China that has passed CE certification by color microsphere method.
Compared with colloidal gold technology, the color microsphere method has the advantages of high sensitivity and low false positive, and is a reliable and effective supplement for nucleic acid detection.
On June 8, 2020, China Chamber of Commerce for Import and Export of Medicines and Health Products dynamically updated the list of medical material manufacturing enterprises that have obtained certification or registration of foreign standards. TopMedLab ranked among them and entered the ” white list ” of new coronavirus detection reagents exported by the Ministry of Commerce .
At the same time, on June 8, TopMedLab also received the US ” FDA PEUA” acceptance number.
The “COVID-19 IgG/IgM antibody detection reagent” independently developed and produced by TopMedLab won the EU CE certification in May 2020. It is the first domestically approved CE microbial method for detection of new coronavirus antibody. Compared with the commonly used “colloidal gold” method detection reagents on the market, it has the advantages of high sensitivity, low false positives, detectable fingertip blood, and the detection result in 8 minutes .
As the global new pneumonia epidemic continues to ferment, the demand for new coronavirus detection kits in overseas countries has suddenly increased, bringing export opportunities to some domestic companies. However, due to the difference in technical standards between my country and the West and some other factors, the new coronavirus pneumonia kits produced by Chinese enterprises have suffered returns from many countries.
Exported products represent the image of the country. In view of the “car rollover” incident of some kits, domestic policies have tightened and customs have strengthened the management of the export of anti-epidemic medical materials. TopMedLab strictly implements national regulations and policies, pays attention to human health, builds a better and stronger Chinese brand image with more accurate and high-quality products, and is committed to contributing to the global anti-epidemic.
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