 |
| Eone Diagnomics Genome Center's COVID-19 Ag Test / Courtesy of EDGC |
By Ko Dong-hwan
Eone Diagnomics Genome Center's (EDGC) latest COVID-19 test kit attained the European CE mark on March 15, paving the way for the Korean genetic analysis company to export its product to the continent.
The EDGC COVID-19 Ag Test can now be exported to European Union member states where the mark is a prerequisite for products sold to consumers.
EDGC said the CE, along with the certifying marks by Korea's Ministry of Food and Drug Safety and the United States' Food and Drug Administration (FDA), entail particularly high standards when approving medicinal products and medical devices for licensed use.
"With the European mark, our plan to export the kit to the United States, Europe, Central and South America and Asia has achieved visible progress, and the prospect now looks promising," said Lee Hwa-seop, chief of the company's virus testing business department.
The portable kit takes less than 15 minutes to confirm whether the user is infected with COVID-19 by analyzing protein from phlegm or mucus. The kit, EDGC said, is better than more conventionally used polymer chain reaction (PCR) methods that require equipment costing thousands of dollars and takes up to six hours to show the results.
According to the company, the kit has 93 percent "sensitivity," or true-positive accuracy, in detecting those infected with the virus, and 100 percent "specificity," or true-negative accuracy, in screening those not infected. The kit's sensitivity level beats the FDA's standard for testing kits, which is 80 percent.
In February, Korea's Ministry of Food and Drug Safety approved the kit for overseas shipments.
