NIHR Community Healthcare MIC, Nuffield Department of Primary Care Health Sciences, University of Oxford, Woodstock Road, Oxford, Oxfordshire, OX26GG, UK.
Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33, 3000, Leuven, Belgium.
Eur J Clin Microbiol Infect Dis. 2020 Aug;39(8):1453-1460. doi: 10.1007/s10096-020-03860-5. Epub 2020 Mar 14.
Annual influenza epidemics cause substantial morbidity and mortality, and the majority of patients with influenza-like illness present to primary care. Point-of-care influenza tests could support treatment decisions. It is critical to establish analytic performance of these platforms in real-life patient samples before uptake can be considered. We aimed to assess the analytical performance and ease of use of the cobas® Liat® PCR POCT in detecting influenza A/B and RSV in samples collected from patients with influenza-like illness in primary care. Sensitivity and specificity of the cobas® Liat® POCT are calculated in comparison with a commercial laboratory-based PCR test (Fast-Track Respiratory Pathogens 21 Plus kit (Fast-Track Diagnostics)). Samples with discordant results were analysed additionally by the RespiFinder 2Smart (PathoFinder) using an Extended Gold Standard (EGS). Acceptability was scored on a five-point Likert scale as well as a failure mode analysis of the cobas® Liat® POCT was performed. Nasal and oropharyngeal swabs were obtained from 140 children and nasopharyngeal swabs from 604 adults (744 patients). The cobas® Liat® POCT had a sensitivity and specificity of 100% (95% CI 99-100%) and 98.1% (95%CI 96.3-99%) for influenza A, 100% (95% CI 97.7-100%) and 99.7% (95%CI 98.7-99.9%) for influenza B and 100% (95% CI 87.1-100%) and 99.4% (95%CI 98.6-99.8%) for RSV, respectively. According to trained lab technicians, the cobas® Liat® POCT was considered easy-to-use, with a fast turn-around-time. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance. Point-of-care influenza tests could support treatment decisions in primary care. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance.
年度流感疫情会导致大量发病率和死亡率，大多数流感样疾病患者会前往初级保健机构就诊。即时检测流感检测可以辅助治疗决策。在考虑采用这些平台之前，必须先确定其实验室检测结果在真实患者样本中的分析性能。我们旨在评估 cobas® Liat® PCR POCT 在检测初级保健机构中流感样疾病患者样本中的流感 A/B 和 RSV 方面的分析性能和易用性。cobas® Liat® POCT 的敏感性和特异性通过与商业实验室基于 PCR 的检测（Fast-Track Respiratory Pathogens 21 Plus 试剂盒（Fast-Track Diagnostics））进行比较来计算。对具有不一致结果的样本，使用 RespiFinder 2Smart（PathoFinder）通过扩展金标准（EGS）进行额外分析。可接受性通过五点李克特量表进行评分，并对 cobas® Liat® POCT 进行失效模式分析。从 140 名儿童中采集鼻和口咽拭子，从 604 名成人（744 名患者）中采集鼻咽拭子。cobas® Liat® POCT 对流感 A 的敏感性和特异性为 100%（95%CI 99-100%）和 98.1%（95%CI 96.3-99%），对流感 B 的敏感性和特异性为 100%（95%CI 97.7-100%）和 99.7%（95%CI 98.7-99.9%），对 RSV 的敏感性和特异性为 100%（95%CI 87.1-100%）和 99.4%（95%CI 98.6-99.8%）。根据经过培训的实验室技术人员，cobas® Liat® POCT 易于使用，具有快速周转时间。cobas® Liat® POCT 是初级保健中流感 A/B 和 RSV 的一种很有前途的去中心化检测平台，因为它提供了相当快速的结果和出色的分析性能。即时检测流感检测可以辅助初级保健中的治疗决策。cobas® Liat® POCT 是初级保健中流感 A/B 和 RSV 的一种很有前途的去中心化检测平台，因为它提供了相当快速的结果和出色的分析性能。
