Benoit Visseaux, Quentin Le Hingrat, Gilles Collin, Valentine Ferré, Alexandre Storto, Houria Ichou, Donia Bouzid, Nora Poey, Etienne de Montmollin, Diane Descamps, Nadhira Houhou-Fidouh
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 2020 AugThe 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. 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. 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). 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. Copyright © 2020 Elsevier B.V. All rights reserved.
Benoit Visseaux, Quentin Le Hingrat, Gilles Collin, Valentine Ferré, Alexandre Storto, Houria Ichou, Donia Bouzid, Nora Poey, Etienne de Montmollin, Diane Descamps, Nadhira Houhou-Fidouh. Evaluation of the RealStar® SARS-CoV-2 RT-PCR kit RUO performances and limit of detection. Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 2020 Aug;129:104520
PMID: 32652476
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