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.

定性 ID Now COVID-19 检测结合了声称的性能和易用性，这似乎将其定位为紧急患者管理的可靠检测。然而，125 个基因组当量/mL 的检测限度 (LOD) 并未得到已发表研究的证实，该研究观察到 LOD 范围从 276 到 20.000 拷贝/mL 不等。我们决定使用定义浓度的 SARS-CoV-2 培养物上清液样品的连续稀释，在更稳健的基础上建立 LOD 值。之后，我们使用 23 个 QCMD 外部质量控制测量方法测试了分析的分析性能。因此，考虑到样品接收杯中的额外稀释，我们发现较低的 95% LOD 为 64 拷贝/mL。对于其预期用途和新建立的 LOD，