Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance
Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance
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DOI：
10.1016/j.jcv.2020.104474
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发表时间：
2020-08-01
影响因子：
8.8
通讯作者：
Coombs, Robert W.
中科院分区：
文献类型：
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作者：
Degli-Angeli, Emily;Dragavon, Joan;Coombs, Robert W.
背景：对SARS-CoV-2病毒的高通量检测对于提高检测能力和减缓新冠肺炎的传播至关重要。雅培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检测方法，运行在自动化的m2000sp/RT系统上。目的：与华盛顿大学临床病毒学实验室(UW病毒学)基于SARS-CoV-2实验室开发的检测(LDT)相比较，评估实时SARS-CoV-2检测的分析和临床性能。方法：通过测试两个重复的两个稀释板，评估实时SARS-CoV-2检测的检测限(LOD)。交叉反应性通过检测24份临床样本对各种非SARS-CoV-2呼吸道病毒的阳性进行评估。用UW病毒学SARS-CoV-2LDT检测30例SARS-CoV-2阳性和30例阴性SARS-CoV-2临床标本。结果：超过实时检测SARS-CoV-2 EUA产物插入物报告的100拷贝/mLLOD，20个重复中有19个检测到50拷贝/mL，20个重复中有16个检测到25拷贝/mL。24例非SARS-CoV-2呼吸道病毒阳性的临床标本，实时检测SARS-CoV-2均为阴性。该方法对临床标本中SARS-CoV-2的检测具有较高的敏感性(93%)和特异性(100%)。用实时SARS-CoV-2检测结果为阴性的两个阳性样本的周期数为35.94或更高，需要在检测前进行稀释。其中一份样本对SARS-CoV-2的LDT也不确定。结论：实时检测SARS-CoV-2是一种可供临床使用的方法。凭借高通量、全自动化的M2000系统，这项检测将加快SARS-CoV-2检测的步伐。
Background: 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.Objective: 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).Methods: 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.Results: 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.Conclusion: 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.