Nationwide External Quality Assessment of SARS-CoV-2 Molecular Testing, South Korea.
Emerg Infect Dis
; 26(10): 2353-2360, 2020 10.
Article
in English
| MEDLINE | ID: covidwho-691167
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
RNA, Viral
/
Coronavirus Infections
/
Clinical Laboratory Techniques
/
Reverse Transcriptase Polymerase Chain Reaction
/
Real-Time Polymerase Chain Reaction
/
Betacoronavirus
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
/
Qualitative research
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Emerg Infect Dis
Journal subject:
Communicable Diseases
Year:
2020
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS