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AQ-TOP COVID-19 Rapid Detection Kit Plus received emergency approval from the Ministry of Food and Drug Safety

  • 운영자
  • Date 2021.01.26
  • Hit 214
Seasun Biomaterials (CEO Park Hee-kyung), a molecular diagnostic company, announced on the 24th that it has received emergency approval for the use of AQ-TOP COVID-19 Rapid Detection Kit Plus, a novel coronavirus infection (COVID 19) molecular diagnostic kit from the Ministry of Food and Drug Safety.

This kit can more accurately and quickly determine whether COVID-19 is positive by using the target gene and artificial nucleic acid with high binding specificity.

In order to increase the accuracy of verification for reinfection or asymptomatic patients, a SARS-CoV-2 gene was added, and ORF1ab and N gene were designed to use two criteria.

As a result of conducting a clinical trial on corona 19 infected patients, both sensitivity and specificity were 100%, demonstrating the effectiveness, and the time taken to test positive was within 15 minutes, Seasun Biomaterials explained.

Representative Park Hee-kyung said, “The product that is approved for emergency use is designed so that it can be used as a single system from nucleic acid extraction to detection in accordance with the global market. It will be useful for emergency screening tests to respond to large-scale population infections.”

시선바이오머티리얼스의 코로나19 진단키트 아큐탑코비드19래피드디텍션키트 플러스 사진출처=시선바이오머티리얼스

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https://www.etnews.com/20200724000212
http://www.wowtv.co.kr/NewsCenter/News/Read?articleId=A202007240380&t=NN
http://www.mdtoday.co.kr/mdtoday/index.html?no=394159
http://www.yakup.com/news/index.html?mode=view&cat=12&nid=247112
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