COVID-19 Testing in South Korea: Current Status and the Need for Faster Diagnostics

摘要

Coronavirus Disease 2019 (COVID-19) has caused an outbreak in China and is spreading worldwide [ ]. As of March 23, 2020, the epidemic has spread exponentially in South Korea, with more than 8,961 patients found positive based on 338,036 tests conducted [ ]. In the aftermath of the Middle East respiratory syndrome (MERS) outbreak in 2015, the South Korean Government established a system that enables emergency use authorization (EUA) of diagnostics (IVDs) for infectious diseases [ ]. As a result, South Korea could swiftly approve its first real-time reverse transcription (RT) PCR kit for COVID-19 testing on February 4, 2020 [ ], following the country’s first reported case of COVID-19 on January 20, 2020 [ ]. Shortly after, four additional kits were approved for testing [ ]. Currently, 15,000 to 20,000 tests per day are being carried out by national central labs and 95 non-governmental clinical laboratories. These laboratories have been all certified by Korean Society for Laboratory Medicine (KSLM) and have also completed external quality assessments by the Korean Association of External Quality Assessment Service (KEQAS). This issue of Ann Lab Med presents the guidelines for the laboratory diagnosis of COVID-19, which is followed in clinical laboratories in South Korea [ ].