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Tytuł pozycji:

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

Tytuł :
Nationwide External Quality Assessment of SARS-CoV-2 Molecular Testing, South Korea.
Autorzy :
Sung H
Han MG
Yoo CK
Lee SW
Chung YS
Park JS
Kim MN
Lee H
Hong KH
Seong MW
Lee K
Chun S
Lee WG
Kwon GC
Min WK
Pokaż więcej
Źródło :
Emerging infectious diseases [Emerg Infect Dis] 2020 Oct; Vol. 26 (10), pp. 2353-2360. Date of Electronic Publication: 2020 Jul 29.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
Język :
English
Imprint Name(s) :
Original Publication: Atlanta, GA : National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), [1995-
MeSH Terms :
Betacoronavirus/*isolation & purification
Clinical Laboratory Techniques/*standards
Coronavirus Infections/*diagnosis
Pneumonia, Viral/*diagnosis
RNA, Viral/*analysis
Real-Time Polymerase Chain Reaction/*standards
Reverse Transcriptase Polymerase Chain Reaction/*standards
Humans ; Laboratory Proficiency Testing ; Pandemics ; Quality Assurance, Health Care ; Reagent Kits, Diagnostic/standards ; Real-Time Polymerase Chain Reaction/methods ; Republic of Korea ; Respiratory System/virology ; Reverse Transcriptase Polymerase Chain Reaction/methods
References :
Ann Lab Med. 2020 Mar 31;40(5):351-360. (PMID: 32237288)
Influenza Other Respir Viruses. 2014 Sep;8(5):585-6. (PMID: 25074677)
Clin Chem. 2020 May 1;66(5):664-666. (PMID: 32077933)
Clin Chem. 2020 Jul 1;66(7):979-981. (PMID: 32321159)
Osong Public Health Res Perspect. 2020 Feb;11(1):3-7. (PMID: 32149036)
Euro Surveill. 2020 Jan;25(3):. (PMID: 31992387)
Clin Microbiol Rev. 2018 Dec 12;32(1):. (PMID: 30541871)
J Clin Virol. 2015 Aug;69:81-5. (PMID: 26209385)
Ann Lab Med. 2016 Sep;36(5):457-62. (PMID: 27374711)
Ann Lab Med. 2020 Nov;40(6):439-447. (PMID: 32539299)
Math Biosci Eng. 2020 Mar 11;17(3):2725-2740. (PMID: 32233563)
Contributed Indexing :
Keywords: COVID-19*; SARS-CoV-2*; South Korea*; coronavirus disease*; external quality assessment*; respiratory infections*; severe acute respiratory syndrome coronavirus 2*; viruses*; zoonoses*
Substance Nomenclature :
0 (RNA, Viral)
0 (Reagent Kits, Diagnostic)
SCR Disease Name :
COVID-19
Entry Date(s) :
Date Created: 20200730 Date Completed: 20200929 Latest Revision: 20201002
Update Code :
20201023
PubMed Central ID :
PMC7510727
DOI :
10.3201/eid2610.202551
PMID :
32723432
Czasopismo naukowe
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.

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