Université de Paris, Assistance Publique - Hôpitaux de Paris, Service de virologie, Hôpital Bichat, Paris, France; UMR 1137-IAME, DeSCID: Decision SCiences in Infectious Diseases Control and Care, INSERM, Université de Paris, Paris, France.
Université de Paris, Assistance Publique - Hôpitaux de Paris, Service de virologie, Hôpital Bichat, Paris, France; UMR 1137-IAME, DeSCID: Decision SCiences in Infectious Diseases Control and Care, INSERM, Université de Paris, Paris, France.
J Clin Virol. 2020 Aug;129:104520. doi: 10.1016/j.jcv.2020.104520. Epub 2020 Jun 29.
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.
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.
使用高效、可靠和敏感的 PCR 检测方法是控制 SARS-CoV-2 大流行的基石。在这项工作中，我们对 Altona 的 RealStar SARS-CoV-2 RT-PCR 试剂盒（仅供研究使用）进行了独立评估，以检测 SARS-CoV-2。
使用定量临床样本，对 RealStar SARS-CoV-2 和当前世界卫生组织推荐的 RT-PCR（世卫组织-PCR）工作流程进行了比较检测限（LoD）评估。还使用 83 份原发性临床样本与世卫组织-PCR 比较评估了 RealStar SARS-CoV-2 检测方法。
RealStar SARS-CoV-2 比世卫组织推荐的检测方法略高，在我们的条件下，检测限为 625 拷贝/ml，而不是世卫组织-PCR 的 1250 拷贝/ml。在 83 份临床样本中，RealStar SARS-CoV-2 与世卫组织-PCR 的总一致性为 97.6%（81/83），敏感性为 97.8%（45/46），特异性为 97.3%（36/37）。对于其他人类冠状病毒（HKU1、OC43、NL63、229E），没有交叉反应。
在对 RealStar SARS-CoV-2 检测方法与参考世卫组织检测方法进行比较时，我们观察到 RealStar 检测方法的敏感性略有提高。它为所有分子生物学实验室提供了一个强大的选择，具有强大的实际 LoD，并且与各种实时 PCR 平台兼容。
