South Korea will soon be granting emergency-use authorization for COVID-19 test kits which can produce results within just one hour.
During the first week of June, the Korea Centers for Disease Control and Prevention, along with the Ministry of Food and Drug Safety, will be taking emergency-use authorization applications for one-hour test kits from local medical firms.
"Applications can be submitted up until June 5th. Then we will start to examine the test kits' effectiveness when the KCDC hands over the applications."
An official from the Ministry of Food and Drug Safety says eligibility is limited to test kits that use the real-time PCR technique, which makes copies of genetic materials in order to amplify them,. due to their high levels of accuracy.
"Test kits should have more than 95-percent test sensitivity and 97-percent test specificity in order to be eligible."
Test sensitivity is the ability to identify those who are infected, whereas test specificity is the ability to detect those who are negative.
Seasun Biomaterials is one of the local firms that is planning to apply.
One of its COVID-19 test kits, which takes just 15 minutes to check if someone has the virus, received emergency use authorization by the U.S. Food and Drug Administration last week.
The kits, when authorized and implemented, are expected to come in handy for certain emergency situations, such as for suspected patients who are due to go into labor.
Currently, COVID-19 test kits approved for emergency use take around six hours to produce a result.
Eum Ji-young Arirang News.