Introduction. The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of symptom onset for COVID-19 if tested within 1 h of specimen collection. Gap statement. Clinical data on the performance of the ID NOW are limited, with many studies varying in their study design and/or having small sample size. Aim. In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing. Methodology. Adults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E gene. Results. In total, 133 individuals were included in the study; 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, positive per cent agreement (PPA) of the ID NOW compared to RT-PCR with 95 % confidence intervals was 89.1 % (82.0–94.1%) and 91.6 % (85.1–95.9%), respectively. When analysing individuals with symptom duration ≤7 days and who had the ID NOW performed within 1 h (n=62), ID NOW PPA increased to 98.2 %. Conclusion. Results from the ID NOW were reliable, especially when adhering to the manufacturer’s recommendations for testing.

中文翻译：

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雅培 ID NOW 在确诊 COVID-19 的有症状个体中的可接受性能

介绍。如果在样本采集后 1 小时内进行检测，ID NOW 已获 FDA 批准用于在 COVID-19 症状出现的前 7 天内检测有症状个体的 SARS-CoV-2。间隙声明。关于 ID NOW 性能的临床数据有限，许多研究的研究设计各不相同和/或样本量较小。目的。在这项研究中，我们旨在确定 ID NOW 与传统 RT-PCR 测试相比的临床性能。方法。该研究招募了社区或医院中患有 COVID-19 的成年人。收集了成对的咽拭子，一个咽拭子立即在一个空的无菌管中运送到实验室进行 ID NOW 检测，另一个在通用运输介质中运送，并通过内部 SARS-CoV-2 RT-PCR 检测针对E基因。结果。总共有 133 个人被纳入研究；129 个样本在 ID NOW 和/或 RT-PCR 中呈阳性。假设任一检测的任何阳性结果都代表真阳性，与 RT-PCR 相比，ID NOW 的阳性百分比一致性 (PPA) 具有 95% 置信区间为 89.1% (82.0–94.1%) 和 91.6% (85.1–95.9%) ）， 分别。当分析症状持续时间≤7 天且在 1 小时内进行 ID NOW 的个体时（n = 62)，ID NOW PPA 增加到 98.2%。结论。ID NOW 的结果是可靠的，尤其是在遵守制造商的测试建议时。