Department of Infection Sciences, North Bristol Trust, Bristol BS10 5NB, United Kingdom.
Department of Infection Sciences, North Bristol Trust, Bristol BS10 5NB, United Kingdom.
J Clin Virol. 2024 Feb;170:105634. doi: 10.1016/j.jcv.2023.105634. Epub 2023 Dec 13.
Prompt identification of patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection on admission to hospital is crucial to ensuring initiation of appropriate treatment, optimising infection control and maintaining patient flow. The Abbott ID NOW™ COVID-19 assay (ID NOW) is a point-of-care, isothermal nucleic acid amplification test, capable of producing a result within minutes, potentially placing it as an invaluable tool in helping to control the coronavirus-disease 2019 (COVID-19) pandemic.
To evaluate the diagnostic accuracy of ID NOW in acute hospital admissions.
A prospective approach to data collection was undertaken in consecutive patients with ID NOW and Hologic Aptima™ SARS-CoV-2 transcription-mediated amplification assay (Aptima TMA) results, across three hospitals in the south-west of England between 1st March and 30th September 2021. A nasal swab was taken for ID NOW and a combined nose and throat swab for Aptima TMA. Measures of diagnostic accuracy were calculated for ID NOW against Aptima TMA. This study was conducted during a period of alpha and delta strain predominance.
19,698 ID NOW assays were performed, of which 12,821 had an Aptima TMA assay performed within 24 hours. ID NOW had sensitivity of 85.2 % (95 % CI, 82.2-87.9) and specificity of 99.6 % (95 % CI, 99.4-99.7) compared with the reference assay. The overall PPV was 91.0 % (95 % CI, 88.5-93.0) and the overall NPV was 99.3 % (95 % CI, 99.1-99.4).
ID NOW offers a valid diagnostic tool to detect SARS-CoV-2, performing comparably to a reference laboratory-based assay which takes longer to provide results.
在患者入院时迅速识别严重急性呼吸综合征冠状病毒 2 型（SARS-CoV-2）感染对于确保及时开始适当的治疗、优化感染控制和维持患者流量至关重要。Abbott ID NOW™ COVID-19 检测（ID NOW）是一种即时、等温核酸扩增检测，能够在数分钟内产生结果，可能成为帮助控制 2019 年冠状病毒病（COVID-19）大流行的宝贵工具。
评估 ID NOW 在急性住院患者中的诊断准确性。
在 2021 年 3 月 1 日至 9 月 30 日期间，在英格兰西南部的三家医院，采用前瞻性方法收集了 ID NOW 和 Hologic Aptima™ SARS-CoV-2 转录介导扩增检测（Aptima TMA）结果的连续患者数据。对 ID NOW 采集鼻拭子，对 Aptima TMA 采集鼻咽拭子。针对 Aptima TMA 计算了 ID NOW 的诊断准确性指标。本研究在阿尔法和德尔塔变异株流行期间进行。
共进行了 19698 次 ID NOW 检测，其中 12821 次在 24 小时内进行了 Aptima TMA 检测。与参考检测相比，ID NOW 的敏感性为 85.2%（95%CI，82.2-87.9），特异性为 99.6%（95%CI，99.4-99.7）。总体阳性预测值为 91.0%（95%CI，88.5-93.0），总体阴性预测值为 99.3%（95%CI，99.1-99.4）。
ID NOW 为检测 SARS-CoV-2 提供了有效的诊断工具，与需要更长时间才能得出结果的参考实验室检测相比，性能相当。
