Nationwide External Quality Assessment of SARS-CoV-2 Molecular Testing, South Korea.
Emerg Infect Dis
; 26(10): 2353-2360, 2020 10.
Article
em En
| MEDLINE
| ID: mdl-32723432
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
Base de dados:
MEDLINE
Assunto principal:
Pneumonia Viral
/
RNA Viral
/
Infecções por Coronavirus
/
Técnicas de Laboratório Clínico
/
Reação em Cadeia da Polimerase Via Transcriptase Reversa
/
Reação em Cadeia da Polimerase em Tempo Real
/
Betacoronavirus
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
/
Qualitative_research
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
Emerg Infect Dis
Ano de publicação:
2020
Tipo de documento:
Article