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FDA announces COVID 19 diagnostic kit ranking

  • 운영자
  • Date 2021.01.26
  • Hit 42
Blind test for accurate performance comparison of the urgently approved COVID-19 molecular diagnostic kit.




The U.S. Food and Drug Administration (FDA) has released the performance rankings of the new coronavirus infection (Corona 19) molecular diagnostic kit.

On the 15th (local time), the FDA analyzed and revealed the performance rankings of the Corona 19 Molecular Diagnostic Kit, which had been approved for emergency use (EUA). The FDA has come out to accurately compare the performance that companies have tested and submitted in their own way.

According to the announcement, the FDA delivered directly produced standard samples and standard operating procedures (SOPs) to 154 molecular diagnostic kit developers (as of August 15th) that were approved for emergency use, and proceeded with a blind test. did. It is intended to accurately compare the performance of molecular diagnostic kits that have been approved by the same sample and experimental method. FDA requested that companies that received performance test kits submit test results according to standard test methods within two weeks.

FDA analyzed the performance of the molecular diagnostic kit with the data submitted (as of August 31). The analysis criterion is the limit of detection (LOD), which means that the lower the LOD, the more sensitive the diagnosis can be. The FDA measured the sensitivity performance rankings of 55 corona19 molecular diagnostic kits from companies that sent the results based on the LOD number and divided them into 13 groups. The highest sensitivity ranges from 180 NDU/mL to 180000 NDU/mL. FDA plans to continuously update the rankings.

So, what are the achievements of domestic companies that have introduced K-Bio to the world? Among the domestic companies, ‘U-TOP COVID-19 Detection Kit’ by Gazeon Biomaterials and “BioCore 2019-nCoV Real Time PCR Kit” by BioCore were jointly included in the third place. It is a joint No. 1 domestic company.

There are only six companies in the first to third place with a joint third place after the No. 1 group PerkinElmer and the No. 2 group ScienCell Research.

Following that, Lab Genomics in the 4th place group (1800 NDU/mL), Jin Matrix in the 7th place (5400 NDU/mL), Kogen Biotech, Access Bio, and SEASUNBIO again in the 8th place (6000 NDU/mL) of Biomaterials Molecular diagnostic kits were ranked. Seegene, Osang Healthcare, and SD Biosensor did not send the results to the FDA.

"One of the two COVID-19 molecular diagnostic kits was ranked in the 3rd group for the general molecular diagnostic kit and the 8th for the rapid diagnosis kit," said Park Hee-kyung, CEO of Seasun Biomaterials, in a call with BioSpectator. “The one that belongs to the group is a loop-mediated isothermal amplification (LAMP) rapid diagnosis kit, which has the best results.” He added, "We will work harder on development to obtain domestic approval."

Meanwhile, the developers of molecular diagnostic kits approved for emergency use by the FDA are Osang Healthcare, Seegen, SD Biosensor, Seasun Biomaterials, Lab Genomics, Gene Matrix, Gencurix, Access Bio, Bioseum, Kogen Biotech, Solgent, Bio There are a total of 12 including cores.


▲FDA가 발표한 코로나19 백신 분자진단키트 퍼포먼스 랭킹(FDA 발표자료 참조)

▲COVID 19 Vaccine Molecular Diagnostic Kit Performance Rankings released by FDA (Refer to FDA announcement data)


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