A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test.
A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test.
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DOI：
10.1016/j.jviromet.2021.114293
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发表时间：
2021-12
影响因子：
3.1
通讯作者：
Chemais M
中科院分区：
文献类型：
--
作者：
Aupaix A;Lazarova E;Chemais M
定性ID Now COVID-19检测结合了声称的性能和易用性，似乎将其定位为紧急患者管理的可靠检测。然而，已发表的研究未证实125基因组当量/mL的声明检测限（LOD），这些研究观察到的LOD范围为276 - 20.000拷贝/mL。我们决定使用规定浓度的SARS-CoV-2培养上清液样品的系列稀释液，在更稳健的基础上建立LOD值。之后，我们用23个QCMD外部质控测量值测试了该测定法的分析性能。因此，考虑到样品接收杯中的额外稀释，我们发现95% LOD较低，为64拷贝/mL。根据比利时最新建议，就其预期用途及新确立的最低检测限而言，ID Now COVID-19被证明是诊断感染性患者的COVID-19的合适检测方法。
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.
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