New COVID-19 test kits that can identify infection within an hour will soon be available in South Korea.
According to industry sources on Monday, a few Korean vitro diagnostic companies, including Seasun Biomaterials, are due to file for emergency use authorization for such kits with the Korea Centers for Disease Control and Prevention (KCDC) during the first week of June.
The new kits are expected to come in handy for emergency surgery, child delivery or other emergency situations where suspected patients need to be tested for the virus infection. Current COVID-19 test kits approved for emergency use take about six hours to show results.
Candidate test kits for the application must meet the sensitivity and specificity parameters, which are higher than 95 percent and 97 percent, respectively.
Seasun Biomaterials, which is preparing for the application, already received FDA emergency use authorization for its gene amplification-based COVID-19 test kit that can identify infection within 15 minutes.
A Korean health authority official said the review process will go as fast as possible and approval may be granted during next month if performance standards are met.
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]