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- Title
Nationwide External Quality Assessment of SARS-CoV-2 Molecular Testing, South Korea.
- Authors
Heungsup Sung; Myung-Guk Han; Cheon-Kwon Yoo; Lee, Sang-Won; Yoon-Seok Chung; Park, Jae-Sun; Mi-Na Kim; Lee, Hyukmin; Ki Ho Hong; Moon-Woo Seong; Lee, Kyunghoon; Sail Chun; Wee Gyo Lee; Gye-Cheol Kwon; Won-Ki Min; Sung, Heungsup; Han, Myung-Guk; Yoo, Cheon-Kwon; Chung, Yoon-Seok; Kim, Mi-Na
- 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.
- Subjects
SOUTH Korea; RNA analysis; VIRAL pneumonia; CLINICAL pathology; REVERSE transcriptase polymerase chain reaction; RESPIRATORY organs; DIAGNOSTIC reagents &; test kits; RESEARCH; RESEARCH methodology; CORONAVIRUS diseases; EVALUATION research; MEDICAL cooperation; MEDICAL laboratories; COMPARATIVE studies; QUALITY assurance; EPIDEMICS; POLYMERASE chain reaction; STANDARDS
- Publication
Emerging Infectious Diseases, 2020, Vol 26, Issue 10, p2353
- ISSN
1080-6040
- Publication type
journal article
- DOI
10.3201/eid2610.202551