Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Matzkies, LM; Leitner, E; Stelzl, E; Assig, K; Bozic, M; Siebenhofer, D; Mustafa, ME; Steinmetz, I; Kessler, HH.
Lack of sensitivity of an IVD/CE-labelled kit targeting the S gene for detection of SARS-CoV-2.
Clin Microbiol Infect. 2020; 26(10): 1417.e1-1411417.
Doi: 10.1016/j.cmi.2020.06.036
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- Führende Autor*innen der Med Uni Graz
- Matzkies Lucie-Marie
- Steinmetz Ivo
- Co-Autor*innen der Med Uni Graz
- Assig Karoline
- Bozic Michael
- Kessler Harald
- Leitner-Meyer Eva
- Siebenhofer David
- Stelzl Evelyn
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- Abstract:
- New molecular tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being rapidly launched in response to the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study was to evaluate the analytical and clinical performance of the VIASURE SARS-CoV-2 S gene RT-PCR Kit on the BD Max™ system and to compare results with those obtained with the cobas® SARS-CoV-2 test on the cobas® 6800 system. For testing the analytical performance, reference material was used. Clinical samples (n = 101) obtained from individuals with symptoms compatible with COVID-19 were studied. Oropharyngeal and nasopharyngeal swabs were collected by using either ESwab™ or UTM™ collection systems. When the analytical performance was evaluated, the sample containing the lowest SARS-CoV-2 concentration tested negative with the VIASURE test whereas results obtained with the cobas® test were found to be concordant with the results expected. Six out of the 101 clinical samples (5.9%) showed an inhibition with the VIASURE test. When analysing the remaining 95 clinical samples, 27 were found to be negative with both assays. Of 68 samples that were positive with the cobas® test, the VIASURE test missed 21 (30.9 %) samples. All of those 21 samples had shown Ct values ≥ 31 with the cobas® 6800 system. None of the samples tested positive with the VIASURE test and negative with the cobas® test. The VIASURE test was impaired by a lack of sensitivity and a relatively high number of invalid results. When using the VIASURE test for routine testing, a significant number of COVID-19-positive samples would have been missed. Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
- Find related publications in this database (Keywords)
- Cobas
- COVID-19
- Diagnostics
- Real-time RT-PCR
- VIASURE