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Launched R-FIND SARS-CoV-2 Neutralizing Antibody ELISA, the coronavirus test reagent

미디어 2021.04.08

 

On April 8th, R-FIND SARS-CoV-2Neutralizing Antibody ELISA Kithas been approved for export by the Ministry of Food and Drug Safety for the first time in Korea.

It has been reported in several major Korean newspapers.

 

Below are excerpts from the article.

 

JungAngilbo / April 8 2021

SG Medical, a company specializing in importing and manufacturing in vitro diagnostic medical devices, announced on the 8th that R-FIND SARS-CoV-2 Neutralizing Antibody ELISA Kit has received approval for export from the Ministry of Food and Drug Safety of Korea. This product can check whether antibodies are produced after vaccination against COVID-19.

 

SG Medical predicted that the demand for neutralizing antibody test kits will increase as the COVID-19 vaccination begins in earnest. According to the New York Times, more than 700 million vaccines are currently administered worldwide. This means that 9 per 100 people were vaccinated. Neutralizing antibodies are antibodies that bind to the virus and neutralize the penetration of cells when infected with a virus such as COVID-19. This is why it is essential to test whether neutralizing antibodies are produced after the COVID-19 vaccination. SG Medical CEO Oh Se-moon said, “The diagnosis of neutralizing antibodies is essential to resume economic activities after completing COVID-19. “We plan to export mainly to Asia and Latin America, and we plan to apply for European CE certification and US Food and Drug Administration Emergency Use Approval (FDA EUA) within the first half of the year,” he said. Since Korea also started vaccination at the end of February of this year, they plan to acquire a domestic license through additional clinical data.

 

SG Medical's COVID-19 neutralizing antibody diagnostic test kit is highly convenient to use based on the enzyme immunoassay method (ELISA). It can be easily used in general small and medium hospitals or diagnostic testing institutions. In addition, many samples can also be analyzed within an hour and a half. In particular, the accuracy is excellent enough to show a higher agreement compared with the standard test method. Existing neutralizing antibody standard test method using plaque inhibition test (PRNT) is difficult to widely use because it requires a laboratory with 3 levels of biosafety level (BSL).

 

CEO Oh said, "Unlike the COVID-19antibody test kit on the market, SG Medical's COVID-19 neutralizing antibody diagnostic kit accurately detects neutralizing antibodies." In particular, through the neutralizing antibody diagnostic test kit, it is possible to determine whether a herd immunity has been formed and the effectiveness of vaccines and treatments.

 

SG Medical has COVID-19 IgG/M/A ELISA (antibody enzyme immunoassay method), Instaview COVID-19 IgG/IgM (antibody rapid diagnosis method), Instaview COVID-19 Antigen, the product lineup will be expanded to include neutralizing antibody diagnostic test kits, and products related to COVID-19 will be sold in earnest.

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이전글 이전 글이 없습니다. 2021.09.17
다음글 SG메디칼, 베인뷰어 국내 독점판매계약 2014.01.16