Public Health Laboratory, Alberta Precision Laboratories, Alberta, Canada.
Department of Pathology and Laboratory Medicine, University of Alberta, Alberta, Canada.
J Med Microbiol. 2021 Jul;70(7). doi: 10.1099/jmm.0.001372.
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. 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. In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing. 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. 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 (=62), ID NOW PPA increased to 98.2 %. Results from the ID NOW were reliable, especially when adhering to the manufacturer's recommendations for testing.
ID NOW 已获得美国食品药品监督管理局 (FDA) 的批准，可用于检测 COVID-19 症状出现后 7 天内的有症状个体，如果在标本采集后 1 小时内进行检测。目前关于 ID NOW 性能的临床数据有限，许多研究在研究设计和/或样本量方面存在差异。在这项研究中，我们旨在确定 ID NOW 与常规 RT-PCR 检测相比的临床性能。我们招募了社区或医院中的 COVID-19 成年患者参与研究。采集配对的咽喉拭子，其中一个咽喉拭子立即用空无菌管运送到实验室进行 ID NOW 检测，另一个用通用运输介质运送，并通过针对 E 基因的内部 SARS-CoV-2 RT-PCR 检测进行检测。共有 133 人纳入研究；129 个样本在 ID NOW 和/或 RT-PCR 上均为阳性。假设任何一种检测方法的阳性结果都代表真阳性，那么与 RT-PCR 相比，ID NOW 的阳性百分比一致性（PPA）在 95%置信区间内分别为 89.1%（82.0-94.1%）和 91.6%（85.1-95.9%）。当分析症状持续时间≤7 天且 ID NOW 在 1 小时内（=62）进行的个体时，ID NOW 的 PPA 增加到 98.2%。ID NOW 的结果是可靠的，尤其是在遵守制造商的测试建议的情况下。
