Evaluation of the RealStar® SARS-CoV-2 RT-PCR kit RUO performances and limit of detection

Abstract

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Characteristics associated with COVID-19 or other respiratory viruses’ infections at a single-center emergency department

“…This rapid multiplex PCR assay allows for detecting 22 viral and bacterial respiratory targets, including influenza, parainfluenza, rhinoviruses/enteroviruses, RSV, metapneumovirus, adenovirus, coronaviruses, bocavirus, Mycoplasma pneumoniae, Legionella pneumophila and Bordetella pertussis [ 10 ]. During the SARS-CoV-2 period, and depending on kit availability, viral investigations were conducted either with the QIAstat-Dx Respiratory SARS-CoV-2 Panel (Qiagen, Hilden, Germany), allowing for the detection of the same respiratory pathogens plus SARS-CoV-2 [ 11 ], or with a combination of the RT-PCR RealStar SARS-CoV-2 Kit RUO (Altona Diagnostics, Hamburg, Germany) [ 12 ] and rapid multiplex PCR FilmArray RP2 (BioFire, BioMérieux, Marcy-L'Etoile, France) [ 13 ], allowing for the detection of the same viral respiratory pathogens except bocavirus.…”

Evaluation of three extraction-free SARS-CoV-2 RT-PCR assays: A feasible alternative approach with low technical requirements

“…One limitation of this study is that we did not exhaustively assess the limit of detection (LOD) of the different assays. The LOD of the main reference assays used in this work, the Altona assay, with extraction, has been estimated in our laboratory at approximately 625 copies/mL ( Visseaux et al, 2020 ), while the WHO reference assay presented LOD between 1000 to 1250 copies/mL ( Visseaux et al, 2020 ; Wirden et al, 2020 ). Another limitation of this study is to have used frozen samples, a conservation process that may have an impact on the Ct of the RT-PCR assay.…”

“…The routine SARS-CoV-2 diagnostic was performed using two assays: (i) RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (Altona diagnostics, France) ( Visseaux et al, 2020 ), quoted after “Altona”, which can be associated to different extraction and amplification devices, and (ii) the Cobas® SARS-CoV-2 kit used on the Cobas® 6800 system (Cobas 6800; Roche Diagnostics, Mannheim, Germany) ( Wirden et al, 2020 ) quoted after “Cobas”.…”

SARS-CoV-2 RNA screening in routine pathology specimens

“…RT-PCR was performed according to the manufacturer's instructions. (Lohse, et al, 2020, Visseaux, et al, 2020 In addition, we used the TaqMan™ internal PCR controls. We tested for TaqMan™ singleplex and multiplex assays.…”