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. 2020 Aug:129:104520.
doi: 10.1016/j.jcv.2020.104520. Epub 2020 Jun 29.

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

Benoit Visseaux  1 , Quentin Le Hingrat  2 , Gilles Collin  2 , Valentine Ferré  2 , Alexandre Storto  2 , Houria Ichou  3 , Donia Bouzid  4 , Nora Poey  5 , Etienne de Montmollin  6 , Diane Descamps  2 , Nadhira Houhou-Fidouh  3
Affiliations

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

Benoit Visseaux et al. J Clin Virol. 2020 Aug.

Abstract

Background: The use of efficient, reliable and sensitive PCR assays is a cornerstone in the race to contain the SARS-CoV-2 pandemic. In this work we performed an independent evaluation of the RealStar® SARS-CoV-2 RT-PCR Kit Researh Use Only (Altona) for SARS-CoV-2 detection.

Methods: A comparative limit of detection (LoD) assessment was performed between RealStar® SARS-CoV-2 and the currently WHO recommended RT-PCR (WHO-PCR) workflow using a quantified clinical sample. Assessment of the RealStar® SARS-CoV-2 assay was also performed using 83 primary clinical samples in comparison with the WHO-PCR.

Results: The RealStar® SARS-CoV-2 demonstrated a slightly higher sensitivity than the WHO recommended assay with a limit of detection at 625 copies/mL instead of 1250 copies/mL for the WHO-PCR in our conditions. The overall percent agreement between RealStar® SARS-CoV-2 and WHO-PCR on 83 clinical samples was 97.6 % (81/83) with a sensitivity at 97.8 % (45/46) and specificity at 97.3 % (36/37). No cross reaction was encountered for the other human coronaviruses (HKU1, OC43, NL63, 229E).

Conclusions: In this comparison of the RealStar® SARS-CoV-2 assay with the reference WHO assay, we observed a slightly better sensitivity of the RealStar® assay. It provides a robust option for all molecular biology laboratories, with a strong real-life LoD and is compatible with various real-time PCR platforms.

Keywords: COVID-19; RT-PCR; SARS-CoV-2; Sensitivity.

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Conflict of interest statement

Declaration of Competing Interest BV received travel accommodations and personal fees from Qiagen and Biomérieux. The other authors have no conflict of interest to declare.

Figures

Fig. 1
Fig. 1
Concordance of cycle threshold values obtained for the E gene with RealStar® SARS-CoV-2 assay and the WHO recommended RT-PCR.
See this image and copyright information in PMC

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