tetano
Editor, Senior Moderator
J Clin Virol
. 2020 Jun 29;129:104520.
doi: 10.1016/j.jcv.2020.104520. Online ahead of print.
Evaluation of the RealStar? SARS-CoV-2 RT-PCR Kit RUO Performances and Limit of Detection
Benoit Visseaux[SUP] 1 [/SUP], Quentin Le Hingrat[SUP] 2 [/SUP], Gilles Collin[SUP] 2 [/SUP], Valentine Ferr?[SUP] 2 [/SUP], Alexandre Storto[SUP] 2 [/SUP], Houria Ichou[SUP] 3 [/SUP], Donia Bouzid[SUP] 4 [/SUP], Nora Poey[SUP] 5 [/SUP], Etienne de Montmollin[SUP] 6 [/SUP], Diane Descamps[SUP] 2 [/SUP], Nadhira Houhou-Fidouh[SUP] 3 [/SUP]
Affiliations
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.
. 2020 Jun 29;129:104520.
doi: 10.1016/j.jcv.2020.104520. Online ahead of print.
Evaluation of the RealStar? SARS-CoV-2 RT-PCR Kit RUO Performances and Limit of Detection
Benoit Visseaux[SUP] 1 [/SUP], Quentin Le Hingrat[SUP] 2 [/SUP], Gilles Collin[SUP] 2 [/SUP], Valentine Ferr?[SUP] 2 [/SUP], Alexandre Storto[SUP] 2 [/SUP], Houria Ichou[SUP] 3 [/SUP], Donia Bouzid[SUP] 4 [/SUP], Nora Poey[SUP] 5 [/SUP], Etienne de Montmollin[SUP] 6 [/SUP], Diane Descamps[SUP] 2 [/SUP], Nadhira Houhou-Fidouh[SUP] 3 [/SUP]
Affiliations
- PMID: 32652476
- DOI: 10.1016/j.jcv.2020.104520
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.