雅培 ID Now COVID-19 快速分子检测的简要性能评估和文献回顾。
A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test.
机构信息
Catholic University of Louvain, 10 Avenue Hippocrate, 1200, Brussels, Belgium; CHR Haute Senne, Department of Medical Biology, 49 Chaussée de Braine, 7060, Soignies, Belgium.
CHR Haute Senne, Department of Medical Biology, 49 Chaussée de Braine, 7060, Soignies, Belgium.
出版信息
J Virol Methods. 2021 Dec;298:114293. doi: 10.1016/j.jviromet.2021.114293. Epub 2021 Sep 20.
The qualitative ID Now COVID-19 assay combines claimed performance and ease of use that seem to position it as a reliable test for urgent patient management. However, the declared limit of detection (LOD) of 125 genome equivalents/mL is not confirmed by the published studies, which observed a range of LOD varying from 276 to 20.000 copies/mL. We decided to establish the LOD value on more robust basis using serial dilutions of a SARS-CoV-2 culture supernatant sample of defined concentration. Afterwards, we tested the analytical performances of the assay with 23 QCMD external quality control measurements. Hence, taking into consideration the additional dilution in the sample receiver cup, we found a lower 95 % LOD of 64 copies/mL. For its intended use and with the new established LOD, ID Now COVID-19 proved to be a suitable test for the diagnosis of COVID-19 in contagious patients, as proposed by the latest Belgian recommendations.
ID Now COVID-19 检测试剂兼具出色的性能和易用性，似乎可以作为一种可靠的检测手段，用于紧急患者管理。然而，已公布的研究并未证实其宣称的检测下限（LOD）为 125 基因组当量/mL，这些研究观察到的 LOD 范围从 276 到 20000 拷贝/mL 不等。我们决定使用经定义浓度的 SARS-CoV-2 培养上清液的系列稀释液，更稳健地确定 LOD 值。之后，我们使用 23 项 QCMD 外部质量控制测量结果对该检测试剂的分析性能进行了测试。因此，考虑到样本接收器杯中额外的稀释，我们发现其 95% LOD 值为 64 拷贝/mL。根据最新的比利时建议，对于其预期用途和新建立的 LOD，ID Now COVID-19 被证明是一种适用于传染性患者 COVID-19 诊断的检测方法。
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