Nationwide External Quality Assessment of SARS-CoV-2 Molecular Testing, South Korea

Sung, Heungsup; Han, Myung-Guk; Yoo, Cheon-Kwon; Lee, Sang-Won; Chung, Yoon-Seok; Park, Jae-Sun; Kim, Mi-Na; Lee, Hyukmin; Hong, Ki Ho; Seong, Moon-Woo; Lee, Kyunghoon; Chun, Sail; Lee, Wee Gyo; Kwon, Gye-Cheol; Min, Won-Ki

External quality assessment (EQA) is essential for ensuring reliable test results, especially when laboratories are using assays authorized for emergency use for newly emerging pathogens. We developed an EQA panel to assess the quality of real-time reverse transcription PCR assays being used in South Korea to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With the participation of 23 public health organization laboratories and 95 nongovernmental laboratories involved in SARS-CoV-2 testing, we conducted qualitative and semiquantitative performance assessments by using pooled respiratory samples containing different viral loads of SARS-CoV-2 or human coronavirus OC43. A total of 110 (93.2%) laboratories reported correct results for all qualitative tests; 29 (24.6%) laboratories had >1 outliers according to cycle threshold values. Our EQA panel identified the potential weaknesses of currently available commercial reagent kits. The methodology we used can provide practical experience for those planning to conduct evaluations for testing of SARS-CoV-2 and other emerging pathogens in the future.