Ameeka Thompson , David Hettle , Stephanie Hutchings , Barry Vipond , Nicholas Veasey , Kerry Grant , Jonathan Turner , Rich Hopes , Jonathan Steer , Rommel Ravanan , O.Martin Williams , Peter Muir
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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.</p></div><div><h3>Objectives</h3><p>To evaluate the diagnostic accuracy of ID NOW in acute hospital admissions.</p></div><div><h3>Study design</h3><p>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.</p></div><div><h3>Results</h3><p>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).</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"170 ","pages":"Article 105634"},"PeriodicalIF":4.0000,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The diagnostic accuracy of the ID NOW COVID-19 point of care test in acute hospital admissions\",\"authors\":\"Ameeka Thompson , David Hettle , Stephanie Hutchings , Barry Vipond , Nicholas Veasey , Kerry Grant , Jonathan Turner , Rich Hopes , Jonathan Steer , Rommel Ravanan , O.Martin Williams , Peter Muir\",\"doi\":\"10.1016/j.jcv.2023.105634\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Objectives</h3><p>To evaluate the diagnostic accuracy of ID NOW in acute hospital admissions.</p></div><div><h3>Study design</h3><p>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. 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引用次数: 0
摘要
背景入院时及时识别严重急性呼吸系统综合征冠状病毒-2(SARS-CoV-2)感染患者对于确保开始适当治疗、优化感染控制和维持患者流量至关重要。雅培 ID NOW COVID-19 检测试剂盒(ID NOW)是一种护理点等温核酸扩增检测试剂盒,能在几分钟内得出结果,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。 研究目的 评估 ID NOW 在急性入院患者中的诊断准确性。研究设计在 2021 年 3 月 1 日至 9 月 30 日期间,对英格兰西南部三家医院中连续出现 ID NOW 和 Hologic AptimaTM SARS-CoV-2 转录介导扩增检测(Aptima TMA)结果的患者进行了前瞻性数据收集。采集鼻拭子检测 ID NOW,采集鼻咽联合拭子检测 Aptima TMA。计算了 ID NOW 和 Aptima TMA 的诊断准确度。这项研究是在α和δ菌株占主导地位的时期进行的。结果 共进行了 19,698 次 ID NOW 检测,其中 12,821 次在 24 小时内进行了 Aptima TMA 检测。与参考测定相比,ID NOW 的灵敏度为 85.2%(95% CI,82.2-87.9),特异性为 99.6%(95% CI,99.4-99.7)。结论ID NOW是检测SARS-CoV-2的有效诊断工具,其性能与实验室参考测定相当,但后者需要更长的时间才能得出结果。
The diagnostic accuracy of the ID NOW COVID-19 point of care test in acute hospital admissions
Background
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.
Objectives
To evaluate the diagnostic accuracy of ID NOW in acute hospital admissions.
Study design
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.
Results
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).
Conclusions
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.
期刊介绍:
The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice.
The journal publishes on topics that include:
• new diagnostic technologies
• nucleic acid amplification and serologic testing
• targeted and metagenomic next-generation sequencing
• emerging pandemic viral threats
• respiratory viruses
• transplant viruses
• chronic viral infections
• cancer-associated viruses
• gastrointestinal viruses
• central nervous system viruses
• one health (excludes animal health)