key: cord-328499-d6cvaxm9
authors: Matzkies, Lucie-Marie; Leitner, Eva; Stelzl, Evelyn; Assig, Karoline; Bozic, Michael; Siebenhofer, David; Mustafa, Maria E.; Steinmetz, Ivo; Kessler, Harald H.
title: Lack of sensitivity of an IVD/CE-labeled kit targeting the S gene for detection of SARS-CoV-2
date: 2020-07-08
journal: Clin Microbiol Infect
DOI: 10.1016/j.cmi.2020.06.036
sha: 
doc_id: 328499
cord_uid: d6cvaxm9

OBJECTIVES: New molecular tests for SARS-CoV-2 are rapidly launched in response to the COVID-19 pandemic. The aim of this study was to evaluate the analytical and the 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 patients with symptoms compatible to COVID-19 were studied. Oro- 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 while 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 analyzing the remaining 95 clinical samples, 27 were found to be negative with both assays. Of 68 samples 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.

Objectives: New molecular tests for SARS-CoV-2 are rapidly launched in response to the COVID- 19 19 pandemic. The aim of this study was to evaluate the analytical and the clinical performance 20 of the VIASURE SARS-CoV-2 S gene RT-PCR Kit on the BD Max™ system and to compare results 21 with those obtained with the cobas® SARS-CoV-2 test on the cobas® 6800 system. 

Detection of 2019 novel 177 coronavirus (2019-nCoV) by real-time RT-PCR

Clinical Evaluation of 179 the cobas SARS-CoV-2 Test and a Diagnostic Platform Switch during 48 Hours in the Midst of the

444212 BR. VIASURE SARS-CoV-2 S-gene Real Time PCR Detection Kit

Comparison of the BD MAX(R) Enteric Bacterial Panel assay 183 with conventional diagnostic procedures in diarrheal stool samples

A microbiological study to 186 investigate the carriage and transmission-potential of Clostridium difficile spores on single-use and 187 reusable sharps containers

Virological 189 assessment of hospitalized patients with COVID-2019

Detection of SARS-CoV-2 in Different Types of 191

SARS-CoV-2 Viral Load in Upper 193

Respiratory Specimens of Infected Patients

Directive 98/79/EC of the European Parliament and of the council of 27 195 October 1998 on in vitro medical devices

Extraction of viral nucleic 197 acids: comparison of five automated nucleic acid extraction platforms

Pooling of nasopharyngeal swab specimens for SARS-CoV-2 199 detection by RT-PCR

Guidelines on COVID-19 in vitro diagnostic tests and their performance

Brussel: Communication from the commission