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Lack of sensitivity of an IVD/CE-labelled kit targeting the S gene for detection of SARS-CoV-2.
Clin Microbiol Infect. 2020 Oct; 26(10):1417.e1-1417.e4.CM

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.Medical-chemical laboratory Dr Mustafa, Dr Richter OG, Salzburg, Austria.Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria. Electronic address: ivo.steinmetz@medunigraz.at.Diagnostic & Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32652240

Citation

Matzkies, L-M, et al. "Lack of Sensitivity of an IVD/CE-labelled Kit Targeting the S Gene for Detection of SARS-CoV-2." Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases, vol. 26, no. 10, 2020, pp. 1417.e1-1417.e4.
Matzkies LM, Leitner E, Stelzl E, et al. 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.e1-1417.e4.
Matzkies, L. M., Leitner, E., Stelzl, E., Assig, K., Bozic, M., Siebenhofer, D., Mustafa, M. E., Steinmetz, I., & Kessler, H. H. (2020). Lack of sensitivity of an IVD/CE-labelled kit targeting the S gene for detection of SARS-CoV-2. Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases, 26(10), e1-e4. https://doi.org/10.1016/j.cmi.2020.06.036
Matzkies LM, et al. 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.e1-1417.e4. PubMed PMID: 32652240.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lack of sensitivity of an IVD/CE-labelled kit targeting the S gene for detection of SARS-CoV-2. AU - Matzkies,L-M, AU - Leitner,E, AU - Stelzl,E, AU - Assig,K, AU - Bozic,M, AU - Siebenhofer,D, AU - Mustafa,M E, AU - Steinmetz,I, AU - Kessler,H H, Y1 - 2020/07/08/ PY - 2020/05/15/received PY - 2020/06/29/revised PY - 2020/06/30/accepted PY - 2020/7/12/pubmed PY - 2020/9/30/medline PY - 2020/7/12/entrez KW - COVID-19 KW - Cobas KW - Diagnostics KW - Real-time RT-PCR KW - VIASURE SP - 1417.e1 EP - 1417.e4 JF - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases JO - Clin Microbiol Infect VL - 26 IS - 10 N2 - OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1469-0691 UR - https://www.unboundmedicine.com/medline/citation/32652240/Lack_of_sensitivity_of_an_IVD/CE_labelled_kit_targeting_the_S_gene_for_detection_of_SARS_CoV_2_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1198-743X(20)30382-7 DB - PRIME DP - Unbound Medicine ER -