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Alternative detection of SARS-CoV-2 RNA by a new assay based on mass spectrometry

Evelyn Stelzl¹, Harald H Kessler¹, Hans G Mustafa²

¹Research Unit Molecular Diagnostics, Diagnostic and Research Center for Molecular Biomedicine, Medical University of Graz, Graz, Austria.

Clinical Chemistry and Laboratory Medicine

|August 13, 2021

Abstract

Objectives:

Accurate detection of SARS-CoV-2 RNA is essential to stopping the spread of SARS-CoV-2. The aim of this study was to evaluate the performance of the recently introduced MassARRAY^® SARS-CoV-2 Panel and to compare it to the cobas^® SARS-CoV-2 Test.

Methods:

The MassARRAY^® SARS-CoV-2 Panel consists of five assays targeting different sequences of the SARS-CoV-2 genome. Accuracy was determined using national and international proficiency panels including 27 samples. For clinical evaluation, 101 residual clinical samples were analyzed and results compared. Samples had been tested for SARS-CoV-2 RNA with the cobas^® SARS-CoV-2 Test.

Results:

When accuracy was tested with the MassARRAY^® SARS-CoV-2 Panel, 25 of 27 (92.6%) samples revealed correct results. When clinical samples were analyzed with the MassARRAY^® SARS-CoV-2 Panel and compared to the cobas^® SARS-CoV-2 Test, 100 samples showed concordant results. One sample was found to be inconclusive with the MassARRAY^® SARS-CoV-2 Panel. When time-to-results were compared, the new assay showed longer total and hands-on times.

Conclusions:

The MassARRAY^® SARS-CoV-2 Panel showed a good performance and proved to be suitable for use in the routine diagnostic laboratory. Especially during phases of shortage of reagents and/or disposables, the new test system appears as beneficial alternative to standard assays used for detection of SARS-CoV-2 RNA.

Keywords:

MassARRAY®SARS-CoV-2 panel PCR SARS-CoV-2 RNA mass spectrometry

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