6-hour test kit targeting 2019-nCoV developed in Korea

KCDC-Korean Society for Laboratory Medicine collaboration, disclosed to private companies

KCDC and Public Health and Environment Institute to use new test kit from Jan. 31

A laboratory test kit to confirm the 2019 novel coronavirus infection in six hours has been co-developed by a government body and private entity.

 

From Jan.

 

31, the new test kit would used by Korea Centers for Disease Control and Prevention (KCDC) and Government Research Institute of Public Health and Environment to test suspected cases, and it would be available for use by private healthcare institutes from early February at earliest.

 

KCDC (Director Jeong Eun-kyeong), Korean Society for Laboratory Medicine (President Kwon Gye-cheol), and Korean Association of External Quality Assessment Service (President Min Hong-ki) have developed, validated and assessed quality of real-time polymerase chain reaction (RT-PCR) to detect 2019 novel coronavirus.

 

They announced KCDC (including National Incheon International Airport Quarantine Station) and 18 Government Research Institute of Public Health and Environment stationed nationwide are to use the kit from Jan.

 

31.

 

The new test takes six hours or less to confirm the infection and the gene-amplifying PCR only requires a single test.

 

The test can be manufactured domestically and it would significantly contribute in proactively response to the virus infection.

 

The existing pan-coronavirus test kit takes a longer time (one to two days) and requires a two-step testing.

 

KCDC stated the new highly credible test kit has been developed based on the 2019 novel coronavirus genetic information, World Health Organization (WHO) test method, and clinical samples, and it was fully disclosed to Korean laboratory test tool manufacturing companies to locally manufacture the kit.

 

Except for China at the moment, an internationally approved and prevalently used test kit is not available, but the Korean-made kit would be distributed to private healthcare institutes in early February at earliest with the help of R&D by Korean manufacturer, assessment support by KCDC, the academic society and the association and emergency approval on medical device by Ministry of Food and Drug Safety (MFDS).

 

Preparing to approve the emergency use of the test kit, MFDS plans to closely cooperate with KCDC and promptly process the reviewing of safety and accuracy with submitted product evaluation material.

 

Korean Society for Laboratory Medicine and Korean Association of External Quality Assessment Service officials said, “The test kit holds a great meaning as public-private cooperation has resulted in an effective diagnostic system in such short period of time.

 

The public-private cooperation would vastly contribute to end the outbreak of 2019 novel coronavirus.” Director Jeong Eun-kyeong of KCDC explained, “The new test kit would enable us to specifically target and diagnose the novel coronavirus, and to respond assertively depending on confirmed infection, even if the outbreak spreads.”