对 ELITe InGenius® 仪器上的 GeneFinder™ COVID-19 Plus RealAmp 试剂盒进行验证。
Validation and verification of the GeneFinder™ COVID-19 Plus RealAmp kit on the ELITe InGenius® instrument.
机构信息
The University of Groningen, University Medical Center Groningen, Department of Medical Microbiology and Infection Prevention, Groningen, the Netherlands.
The University of Groningen, University Medical Center Groningen, Department of Medical Microbiology and Infection Prevention, Groningen, the Netherlands.
出版信息
J Virol Methods. 2022 Feb;300:114378. doi: 10.1016/j.jviromet.2021.114378. Epub 2021 Nov 24.
BACKGROUND
Throughout the SARS-CoV-2 pandemic, a rapid identification of the virus was essential to quickly recognize positive cases and limit further spread by applying appropriate infection prevention. Many diagnostic laboratories use a multiplex Real-Time PCR assay, as they are not only highly sensitive but also specific. Currently, there are several assays and platforms in the market available which target different SARS-CoV-2 genes. The aim of this study was to validate and verify the GeneFinder™ COVID-19 PLUS RealAmp kit on the ELITe InGenius® instrument and compare to the national reference method.
METHODS
GeneFinder™ COVID-19 PLUS RealAmp kit was evaluated against the routine WHO in- house Real-Time PCR assay, which is also the national reference method in the Netherlands and used in our laboratory. The sensitivity was tested using the analytical panel from Qnostics (Glasgow, United Kingdom) and the specificity was tested with patient material comprising of other seasonal respiratory viruses. In addition, 96 clinical samples initially analyzed by routine Real-Time PCR were tested using the GeneFinder™ COVID-19 PLUS RealAmp kit on the ELITe InGenius® instrument.
RESULTS
The GeneFinder™ COVID-19 PLUS RealAmp kit had a similar performance compared to routine in-house testing, with a limit of detection of 500 dC/mL for the RdRp-gene and E gene. Meanwhile, the N gene showed a limit of detection of 50 dC/mL. The SARS-CoV-2 test was highly specific and detected no other respiratory viruses. The results of the clinical samples were comparable between both assays with similar Ct values observed for the in-house Real-Time-PCR and the GeneFinder™ COVID-19 PLUS RealAmp kit for the N gene.
CONCLUSION
The GeneFinder™ COVID-19 PLUS RealAmp kit on the ELITe InGenius® instrument had an appropriate sensitivity and specificity that could be used in small scale laboratories or during night shifts where accurate diagnostics are crucial.
背景
在整个 SARS-CoV-2 大流行期间，快速识别病毒对于快速识别阳性病例并通过实施适当的感染预防措施来限制进一步传播至关重要。许多诊断实验室使用多重实时 PCR 检测方法，因为它们不仅高度敏感，而且具有特异性。目前，市场上有多种针对不同 SARS-CoV-2 基因的检测方法和平台。本研究旨在验证 GeneFinder™ COVID-19 PLUS RealAmp 试剂盒在 ELITe InGenius®仪器上的性能，并与国家参考方法进行比较。
方法
GeneFinder™ COVID-19 PLUS RealAmp 试剂盒与 WHO 内部实时 PCR 检测方法进行了评估，该方法也是荷兰的国家参考方法，也在我们实验室使用。使用 Qnostics（英国格拉斯哥）的分析面板测试了灵敏度，并用包含其他季节性呼吸道病毒的患者材料测试了特异性。此外，使用 GeneFinder™ COVID-19 PLUS RealAmp 试剂盒在 ELITe InGenius®仪器上对最初通过常规实时 PCR 分析的 96 例临床样本进行了测试。
结果
GeneFinder™ COVID-19 PLUS RealAmp 试剂盒与常规内部检测具有相似的性能，RdRp 基因和 E 基因的检测限为 500 dC/mL。同时，N 基因的检测限为 50 dC/mL。SARS-CoV-2 检测具有高度特异性，未检测到其他呼吸道病毒。两种检测方法的临床样本结果具有可比性，对于 N 基因，内部实时 PCR 和 GeneFinder™ COVID-19 PLUS RealAmp 试剂盒的 Ct 值相似。
结论
ELITe InGenius®仪器上的 GeneFinder™ COVID-19 PLUS RealAmp 试剂盒具有适当的灵敏度和特异性，可用于小型实验室或夜班期间，此时准确的诊断至关重要。
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