Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States.
Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States.
J Clin Virol. 2020 Aug;129:104474. doi: 10.1016/j.jcv.2020.104474. Epub 2020 May 28.
High-throughput assays for the SARS-CoV-2 virus are critical to increasing test capacity and slowing the spread of COVID-19. Abbott Molecular developed and received emergency use authorization (EUA) to deploy the new RealTime SARS-CoV-2 assay, run on the automated m2000sp/rt system.
To evaluate analytical and clinical performance of the RealTime SARS-CoV-2 assay compared to the SARS-CoV-2 CDC-based laboratory developed test (LDT) in clinical use by the University of Washington Clinical Virology Laboratory (UW Virology).
RealTime SARS-CoV-2 assay limit of detection (LOD) was evaluated by testing two dilution panels of 60 replicates each. Cross-reactivity was evaluated by testing 24 clinical samples positive for various non‒SARS-CoV-2 respiratory viruses. Clinical performance was evaluated using 30 positive and 30 negative SARS-CoV-2 clinical samples previously tested using the UW Virology SARS-CoV-2 LDT.
Exceeding the 100 copies/mL LOD reported in the RealTime SARS-CoV-2 assay EUA product insert, 19 of 20 replicates were detected at 50 copies/mL and 16 of 20 replicates were detected at 25 copies/mL. All clinical samples positive for 24 non‒SARS-CoV-2 respiratory viruses were SARS-CoV-2 negative on the RealTime SARS-CoV-2 assay. The assay had high sensitivity (93%) and specificity (100%) for detecting SARS-CoV-2 in clinical samples. Two positive samples that tested negative with the RealTime SARS-CoV-2 assay had cycle numbers of 35.94 or greater and required dilution prior to testing. One of these samples was also inconclusive on the SARS-CoV-2 LDT.
The RealTime SARS-CoV-2 assay is acceptable for clinical use. With the high-throughput, fully automated m2000 system, this assay will accelerate the pace of SARS-CoV-2 testing.
高通量检测 SARS-CoV-2 病毒对于提高检测能力和减缓 COVID-19 的传播至关重要。雅培分子公司开发并获得了紧急使用授权（EUA），以部署新的实时 SARS-CoV-2 检测，该检测在自动化 m2000sp/rt 系统上运行。
评估实时 SARS-CoV-2 检测与华盛顿大学临床病毒学实验室（UW 病毒学）临床使用的基于 CDC 的 SARS-CoV-2 实验室开发检测（LDT）相比的分析和临床性能。
通过测试两个 60 个重复的稀释面板评估实时 SARS-CoV-2 检测的检测限（LOD）。通过测试 24 种临床样本对各种非 SARS-CoV-2 呼吸道病毒的交叉反应性进行评估。通过使用 30 份先前使用 UW 病毒学 SARS-CoV-2 LDT 检测的 SARS-CoV-2 阳性和 30 份阴性临床样本评估临床性能。
实时 SARS-CoV-2 检测 EUA 产品插页中报告的 100 拷贝/mL LOD 以上，20 个重复中有 19 个在 50 拷贝/mL 时被检测到，16 个在 25 拷贝/mL 时被检测到。对 24 种非 SARS-CoV-2 呼吸道病毒呈阳性的所有临床样本在实时 SARS-CoV-2 检测中均为 SARS-CoV-2 阴性。该检测对临床样本中 SARS-CoV-2 的检测具有高灵敏度（93%）和特异性（100%）。两个实时 SARS-CoV-2 检测呈阴性的阳性样本的循环数为 35.94 或更高，需要稀释后再进行检测。其中一个样本在 SARS-CoV-2 LDT 上也无法得出结论。
实时 SARS-CoV-2 检测可用于临床。凭借高通量、全自动的 m2000 系统，该检测将加速 SARS-CoV-2 的检测速度。
