Abstract
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.
Highlights
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
In June 2016, South Korea enacted emergency use authorization (EUA) legislation with the aim of supplying commercial kits to meet the demands of nongovernmental clinical laboratories and to guarantee quality assurance through mandatory technical training regarding standardized laboratory guidelines and external quality assessment (EQA) [6]
Participants Because participation in the nationwide EQA requested by the Korea Centers for Disease Control (KCDC) was mandatory for the 118 laboratories conducting SARS-CoV-2 tests, these laboratories were included in the our study by default
Summary
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). As of June 27, 2020, the pandemic had Author affiliations: University of Ulsan College of Medicine and Asan Medical Center, Seoul, South Korea In June 2016, South Korea enacted emergency use authorization (EUA) legislation with the aim of supplying commercial kits to meet the demands of nongovernmental clinical laboratories and to guarantee quality assurance through mandatory technical training regarding standardized laboratory guidelines and external quality assessment (EQA) [6]. We developed an EQA panel to assess the quality of SARSCoV-2 rRT-PCR assays in South Korea
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