SEOUL, May 26 (Korea Bizewire) — Diagnostic kits that can deliver a test result for the novel coronavirus within an hour will be available in South Korea as soon as June.
Some domestic companies specializing in in-vitro diagnostic medical devices, including Seasun Biomaterials, are reportedly planning to apply to the Korea Centers for Disease Control and Prevention (KCDC) early next month for Emergency Use Authorization of an “emergency” COVID-19 diagnostic kit.
The KCDC will receive applications for Emergency Use Authorization for diagnostic kits that can be used for COVID-19 emergency screening from June 1 to 5.
The introduction of emergency diagnostic kits to rapidly check whether patients are infected with the coronavirus before urgent surgery or delivery has become a necessity.
Until now, the diagnostic kits approved for emergency use in Korea have taken about six hours to deliver results, which has led many to say that they are difficult to use in emergency situations where time is of the essence.
Accordingly, the KCDC and the Ministry of Food and Drug Safety have decided to prepare separate procedures for the approval of emergency diagnostic kits, and have encouraged local companies to submit their tests for approval.
In order to obtain Emergency Use Authorization for an emergency iagnostic kit, it is necessary to prove that it can be completed within an hour from inspection to finding results.
The new diagnostic kits for the novel coronavirus are limited to those that amplify nucleic acids in some genes such as real-time gene amplification (RT-PCR).
Tests making use of the immunodiagnostic method for detecting specific antibodies will not be included in this new initiative.
Sensitivity, which diagnoses that one is infected with the virus in a clinical performance evaluation, must be at least 95 percent, and specification, which filters out normal people without a virus, must be at least 97 percent for the test to be approved.
Seasun Biomaterials has already been approved by the U.S. Food and Drug Administration (FDA) for emergency use of products that can diagnose COVID-19 infections within 15 minutes by gene amplification.
The company predicts that the accuracy of the product will be close to 100 percent, which will be useful for screening for emergency use.
“We will review the new tests as soon as possible, so if there are products that meet the performance standards, approval may be made sometime next month,” an official from the Ministry of Food and Drug Safety said.
Ashley Song (firstname.lastname@example.org)