First results of a national external quality assessment scheme for the detection of SARS-CoV-2 genome sequences.
J Clin Virol
; 129: 104537, 2020 08.
Article
in English
| MEDLINE | ID: covidwho-633879
ABSTRACT
BACKGROUND:
Broad and decentralised testing of SARS-CoV-2 RNA genomes is a WHO-recommended strategy to contain the SARS-CoV-2 pandemic by identifying infected cases in order to minimize onward transmission. With the need to increase the test capacities in Austria, nation-wide numerous laboratories rapidly implemented assays for molecular detection of SARS-CoV-2 based on real-time RT-PCR assays. The objective of this study was to monitor reliability of the laboratory results for SARS-CoV-2 RNA detection through an external quality assessment (EQA) scheme.METHODS:
For this, the Center for Virology, Medical University of Vienna was tasked by the Federal Ministry of Social Affairs, Health, Care and Consumer Protection to perform the first Austrian EQA on SARS-CoV-2 which was organised in cooperation with the Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA). Data were analysed on the basis of qualitative outcome of testing in relation to the nucleic acid (NA) extraction and detection methods used. RESULTS ANDCONCLUSION:
A total of 52 laboratories participated, contributing results from 67 test panels comprising 42 distinct combinations of NA extraction and PCR reagents. By testing 3 positive (CT values S1, 28.4; S2, 33.6; S3, 38.5) and 1 negative sample, no false-positive results were obtained by any of the laboratories. Otherwise, 40/67 tests (60 %) detected all positive samples correctly as positive, but 25/67 tests (37 %) did not detect the weakest positive sample (S3), and 3 % reported S2 and S3 as false-negative. Improvement in test sensitivity by focusing on NA extraction and/or PCR-based detection is recommended.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Coronavirus Infections
/
Clinical Laboratory Techniques
/
Molecular Diagnostic Techniques
/
Laboratory Proficiency Testing
/
Betacoronavirus
Type of study:
Diagnostic study
/
Prognostic study
/
Qualitative research
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
Europa
Language:
English
Journal:
J Clin Virol
Journal subject:
Virology
Year:
2020
Document Type:
Article
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