Urgent Care, The Everett Clinic-Part of Optum, Everett, United States.
Department of Pathology, James J Peters VA Medical Center, Bronx, United States.
Elife. 2021 Apr 20;10:e65726. doi: 10.7554/eLife.65726.
Diagnosis of SARS-CoV-2 (COVID-19) requires confirmation by reverse transcription-polymerase chain reaction (RT-PCR). Abbott ID NOW provides fast results but has been criticized for low sensitivity. Here we determine the sensitivity of ID NOW in an ambulatory population presented for testing. The study enrolled 785 symptomatic patients, of whom 21 were positive by both ID NOW and RT-PCR, and 2 only by RT-PCR. All 189 asymptomatic patients tested negative. The positive percent agreement between the ID NOW assay and the RT-PCR assay was 91.3%, and negative percent agreement was 100%. The results from the current study were included into a larger systematic review of literature where at least 20 subjects were simultaneously tested using ID NOW and RT-PCR. The overall sensitivity for ID NOW assay was calculated at 84% (95% confidence interval 55-96%) and had the highest correlation to RT-PCR at viral loads most likely to be associated with transmissible infections.
SARS-CoV-2（COVID-19）的诊断需要通过逆转录-聚合酶链反应（RT-PCR）进行确认。Abbott ID NOW 提供快速的结果，但因其灵敏度低而受到批评。在这里，我们确定了 ID NOW 在门诊人群中进行检测的灵敏度。该研究纳入了 785 名有症状的患者，其中 21 名患者的 ID NOW 和 RT-PCR 检测均为阳性，而只有 2 名患者的 RT-PCR 检测为阳性。所有 189 名无症状患者的检测结果均为阴性。ID NOW 检测与 RT-PCR 检测的阳性符合率为 91.3%，阴性符合率为 100%。当前研究的结果被纳入了一项更大的文献系统评价中，其中至少有 20 名患者同时使用 ID NOW 和 RT-PCR 进行了检测。ID NOW 检测的总灵敏度为 84%（95%置信区间为 55-96%），与 RT-PCR 的相关性最高，与最有可能导致传染性感染的病毒载量相关。
