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. 2020 Aug:129:104537.
doi: 10.1016/j.jcv.2020.104537. Epub 2020 Jul 6.

First results of a national external quality assessment scheme for the detection of SARS-CoV-2 genome sequences

I Görzer  1 , Ch Buchta  2 , P Chiba  2 , B Benka  3 , J V Camp  4 , H Holzmann  4 , E Puchhammer-Stöckl  4 , S W Aberle  5
Affiliations

First results of a national external quality assessment scheme for the detection of SARS-CoV-2 genome sequences

I Görzer et al. J Clin Virol. 2020 Aug.

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 and conclusion: 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: COVID-19 pandemic; Evaluation; External quality assessment; Molecular test; SARS-CoV-2; Standardisation.

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Conflict of interest statement

Declaration of Competing Interest The Authors have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Boxplot of CT values for each sample and the indicated target genes. Boxplots represent quartiles, showing 50 % IQR and median within the box.
See this image and copyright information in PMC

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