Three rapid diagnostic kits approved in S. Korea for emergency use.
June 24, 2020
SEOUL -- In response to growing calls from emergency room medical staff, South Korea's state public health agency has approved three rapid diagnostic kits capable of detecting a new coronavirus in less than an hour for the treatment of ordinary patients who require urgent surgery or delivery.
The real-time polymerase chain reaction (RT-PCR) method that amplifies specific DNA samples and takes at least six hours to get results has been approved and used widely in South Korea due to its reliability. However, doctors and nurses have called for the approval of rapid diagnostic kits that could be used in emergency situations.
Based on an experts' review of 13 products, the Ministry of Food and Drug Safety said it has approved three rapid diagnostic kits: Ezplex SARS-CoV-2 FAST Kit from SML Genetree, a maker of molecular diagnostics, Labgenomics' LabGunTM COVID-19 Fast RT-PCR Kit and BioSewoom's Real-Q Direct SARS-CoV-2 Detection Kit.
"The products approved for emergency use this time is expected to help establish a rapid diagnosis system, such as preventing delays in the treatment of emergency patients," the ministry said in a statement, adding it would decide whether to approve the remaining 10 products through evaluation.
Labgenomics claimed to have upgraded the function of real-time PCR kits to acquire the outcome of testing in 35 minutes. BioSewoom, a molecular genetic test kit producer, developed a gene diagnostic reagent capable of yielding accurate results in 50 minutes and commercialized detection kits using the RT-PCR method that amplifies two gene regions with one tube.
Along with RT-PCR, South Korean companies have developed antibody and antigen diagnostic kits. The global market for COVID-19 diagnostic kits is expected to reach $44.4 billion by the end of this year, according to Market Study Report, a global market research firm.
- Lim Chang-won Reporter
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