We evaluated the analytical performance of ID NOW™ COVID-19 2.0 assay versus conventional real-time reverse transcription-polymerase chain reaction (RT-PCR) using a total of 792 clinical samples from nasopharyngeal and oropharyngeal swabs, stored in frozen universal transport medium samples. Positive percent agreement (PPA) and negative percent agreement of ID NOW were 97.6 % and 100 %, respectively. The overall percent agreement between ID NOW and RT-PCR was 99.5 %. The PPA of ID NOW in detecting SARS-CoV-2 in 164 RT-PCR positive patients, all of whom had symptoms related COVID-19, was 97.1 % within 8 days since symptom onset, 97.9 % from 8 to 14 days since symptom onset, and 97.6 % after 14 days since symptom onset, with no significant difference between the days since symptom onset. The ID NOW assay demonstrated good performance, providing a rapid and randomly accessible alternative to conventional RT-PCR for timely SARS-CoV-2 detection, particularly in situations requiring rapid results for patient care.

我们使用来自鼻咽和口咽拭子的总共 792 个临床样本（储存在冷冻通用传输介质样本中）评估了 ID NOW™ COVID-19 2.0 检测与传统实时逆转录聚合酶链反应 (RT-PCR) 的分析性能。ID NOW 的正一致性百分比 (PPA) 和负一致性百分比分别为 97.6 % 和 100 %。ID NOW 和 RT-PCR 之间的总体一致性百分比为 99.5 %。ID NOW 在 164 名 RT-PCR 阳性患者（所有患者均出现与 COVID-19 相关的症状）中检测 SARS-CoV-2 时，症状出现后 8 天内的 PPA 为 97.1 %，症状出现后 8 至 14 天内的 PPA 为 97.9 % ，以及症状出现 14 天后的 97.6%，症状出现后的天数之间没有显着差异。ID NOW 检测表现出良好的性能，为及时检测 SARS-CoV-2 提供了传统 RT-PCR 的快速且随机的替代方案，特别是在需要快速获得患者护理结果的情况下。