DNA LINK’s product waiting for FDA approval
South Korea’s rapid test kit for COVID-19 has been awarded the CE mark, which is necessary to export the product to European countries and other regions.
DNA LINK said on Nov. 5 that its diagnostic kit, dubbed “AccuFIND COVID19 Ag,” had won the CE certification by meeting the safety and performance requirements in Europe.
As a result, the Seoul-based company will be able to export its assay kits to Europe and other countries, which demand the widely-used certificate.
“The second wave of the novel coronavirus is now hitting Europe. Hence, the CE mark is expected to boost our exports,” a DNA LINK official said.
DNA LINK is expecting another milestone in the near future as the outfit is waiting for the approval of the U.S. Food and Drug Administration, the official noted.
AccuFIND COVID19 Ag is designed to detect the new coronavirus in patients even if they have just become infected, which is possible because the diagnostic reagent is the antigen.
In addition, the company said that the test time would be between 10-15 minutes, much faster than conventional tests that take a few hours.
An independent study of “AccuFIND COVID19 Ag” showed a 97.5 percent sensitivity and 100 percent specificity, according to DNA LINK.
This means that the kit will correctly return a positive result for 97.5 percent of people who are infected while return a negative result for all of people who are not.
DNA LINK explained another advantage of its new product _ testers do not need the expensive equipment necessary for traditional RT-PCT tests since it detects COVID-19 just through a sample collected from a person’s nose or throat.
DNA LINK has teamed up with GTG Wellness, a Korean firm that manufactures and distributes medical equipment, to find global customers of AccuFIND COVID19 Ag.
Under the bilateral cooperation, they recently struck a contract to export millions of test kits to Ukraine.
“Discussions are underway with multiple buyers,” the official said.