The U.S. Food and Drug Administration (FDA) has released a performance ranking of new coronavirus infectious disease (Corona19) molecular diagnostic kits.
The FDA analyzed the performance rankings of the Corona 19 molecular diagnostic kit, which was approved for emergency use (EUA) on 15 May (local time). The FDA went directly to compare the performance submitted by companies experimenting in their own way.
According to the announcement, the FDA delivered a standard sample and standard experiment (Standard operating procedure, SOP) produced directly to 154 molecular diagnostic kit developers (as of August 15) receiving urgent use approval in a blind test (blind test) manner. The FDA requested that companies receiving performance test kits submit test results in accordance with the standard testing method within two weeks.
The FDA analyzed the performance of molecular diagnostic kits with data submitted (as of August 31). Analysis criteria means that the lower the LOD to the detection limit (LOD) can be diagnosed more sensitively. The FDA measured the sensitivity performance rankings of 55 corona 19 molecular diagnostic kits in companies that sent results based on LOD figures and divided them into a total of 13 groups. The highest sensitivity is from 180NDU/mL to 180000NDU/mL. The FDA plans to continue to update its rankings.
So what about the performance of Korean companies that announced K-Bio to the world? Among korean companies, The U-TOP COVID-19 Detection Kit and Biocore 2019-nCoV Real Time PCR Kit were included in the joint third-place group. It is the joint no.1 company in Korea.
Only six companies are in the 1st and 3rd place group, followed by the #1 group, PerkinElmer, and scienCell Research, the second-largest group.
Followed by the fourth-place group (1800NDU / mL) rapzinomics, the seventh-place group (5400NDU / mL) in the gene matrix, Kozen biotech, access bio, 8th group (6000NDU / mL) again in the gaze biomaterials quick molecular diagnostic kit was ranked. Seegen, OhSang Healthcare, Andy Biosensor, etc. did not send the results to the FDA.
In a call with biospectator, Park Hee-kyung, ceo of Biomaterials, said, “One of the two corona 19 molecular diagnostic kits is ranked in the third group for the general molecular diagnostic kit, and the rapid diagnostic kit is ranked in the eighth place group,” and emphasized that “being in the eighth group is the loop-mediated isothermal amplification (LAMP) method of rapid diagnostic kits, which produce the best results in this method.” He added, “We will work harder to develop in order to get approval from the country.”
On the other hand, molecular diagnostic kit developersanctioned for urgent use by the FDA is ohsang healthcare, Seesen, SD Biosensor, Gaze BioMaterials, Labzinomics, Gene Matrix, Gencurix, Access Biobio, Bioseum, Kozen Biotech, Solgent, Biococoa, etc. total 12.