|Eone Diagnomics Genome Center's COVID-19 Ag Test / Courtesy of EDGC|
By Ko Dong-hwan
A new COVID-19 testing kit developed by Korean genetic analysis company Eone Diagnomics Genome Center has been approved for export by the government after being proven to be 93.8 percent accurate and to yield results faster than conventional tests.
EDGC said Feb. 19 that its "COVID-19 Ag Test" was approved for overseas shipment by the Ministry of Food and Drug Safety.
By analyzing protein from phlegm or mucus, the portable kit takes less than 15 minutes to confirm whether the user is infected. The kit, according to the company, is better than that of the polymer chain reaction method, which is used in the conventional molecular diagnostic test, and which requires equipment costing tens of millions of won and takes up to six hours to yield results.
The Ag Test also has 93.8 percent "sensitivity," or true-positive accuracy, in finding those infected with the virus, and 100 percent "specificity," or true-negative accuracy, in screening those not infected. The level of the kit's sensitivity is above the United States Food and Drug Administration's standard for testing kits, which is 80 percent.
Previously available tests, the company said, had only up to 70 percent accurate sensitivity because the antibodies, used to extract the virus' pathogen, are difficult to produce while preserving its qualitative state.
EDGC will export the kit to the Europe as soon as it acquires a CE mark, which is given once passing the European Union standards for health, safety and the environment, a company official said.
"We are getting inquiries from those interested in the kit and already began holding talks about signing procurement contracts with local companies," the official said. "Not only will the kit be widely used in quarantining and medical sites, demand will rise even during the post-COVID-19 era in schools and other various public places."