FDA Emergency Channel approves the launch of a new coronavirus nucleic acid testing kit
Last Update: 2021-03-03
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, DiaCarta's declared QuantiVirusTM new coronavirus nucleic acid test kit was officially approved for listing by the FDA on April 9, Beijing time. Prior to this, Diki QuantiVirusTM was CE/IVD certified in the European Union. To this end, DiaCarta will contribute significantly to global outbreak control.
Since the outbreak, more than 1.5 million people have been cumulatively diagnosed with the new coronavirus (SARS-Cov-2), including more than 430,000 in the United States and 88,000 globally. Globally, the epidemic is still raging. Fast and accurate virus detection is an important link in the prevention and control of the current epidemic, and it is also an urgent need for the health and safety of people around the world.
QuantiVirusTM's new coronavirus nucleic acid testing kit uses the company's own molecular diagnostic patented technology to quickly and accurately detect each known SARS-Cov-2 strain. QuantiVirusTM optimizes routine experimental procedures to reduce the testing process time to less than 2 hours, while QuantiVirusTM amplifies the specific regions of all three genes N, Orf1ab, and E genes of the SARS-Cov-2 virus, ensuring the sensitivity and specificity of the test, with a good linear relationship from 1 to 10 million copies.
DiaCarta has independent clinical testing centers (medical laboratories) in Both China and the United States. The company also declared and approved the FDA EUA LDT, which has provided coronavirus testing services at the DiaCarta CLIA Lab Clinical Testing Center in the United States to make a positive contribution to outbreak control.
DiaCarta is a Silicon Valley, California-based precision medicine molecular diagnostic company with ISO13485 certification and CLIA certification and a number of unique technology platforms. Headquartered in Nanjing, Jiangsu Province, China has an independent third-party inspection laboratory, ISO13485 and MDSAP system certified production workshop, built in line with diagnostic reagent development standards of research and development laboratory. The company specializes in the clinical application of molecular biology technology, in addition to QuantiVirusTM SARS-Cov-2 test kit, DiaCarta focuses on cancer and infectious disease early screening and treatment monitoring liquid biopsy, the company's own research and development of XNA and SuperbDNATM technology platform around the world launched ColoScapec bowel cancer early screening blood testing, as well as QuantiDNATM radiation monitoring blood testing and other unique products.
Finally, we hope that countries all over the world will overcome the epidemic at an early time, stay away from the disease and achieve good health. DiaCarta (Diki Creatures) is with you to fight the disease.
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