Merrick B, Noronha M, Batra R, Douthwaite S, Nebbia G, Snell L B, Pickering S, Galao R P, Whitfield J, Jahangeer A, Gunawardena R, Godfrey T, Laifa R, Webber K, Cliff P R, Cunningham E, Neil S J D, Gettings H, Edgeworth J D, Harrison H L
Centre for Clinical Infection and Diagnostics Research, Department of Infectious Diseases, School of Immunology and Microbial Sciences, King's College London, UK.
Directorate of Infection, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Infect Prev Pract. 2021 Dec;3(4):100186. doi: 10.1016/j.infpip.2021.100186. Epub 2021 Nov 18.
Point-of-care (POC) SARS-CoV-2 lateral-flow antigen detection (LFD) testing in the emergency department (ED) could inform rapid infection control decisions but requirements for safe deployment have not been fully defined.
Review of LFD test results, laboratory and POC-RT-PCR results and ED-performance metrics during a two-week high SARS-CoV-2 prevalence period followed by several months of falling prevalence.
Determine whether LFD testing can be safely deployed in ED to provide an effective universal SARS-CoV-2 testing capability.
93% (345/371) of COVID-19 patients left ED with a virological diagnosis during the 2-week universal LFD evaluation period compared to 77% with targeted POC-RT-PCR deployment alone, on background of approximately one-third having an NHS Track and Trace RT-PCR test-result at presentation. LFD sensitivity and specificity was 70.7% and 99.1% respectively providing a PPV of 97.7% and NPV of 86.4% with disease prevalence of 34.7%. ED discharge-delays (breaches) attributable to COVID-19 fell to 33/3532 (0.94%) compared with the preceding POC-RT-PCR period (107/4114 (2.6%); p=<0.0001). Importantly, LFD testing identified 1 or 2 clinically-unsuspected COVID-19 patients/day. Three clinically-confirmed LFD false positive patients were appropriately triaged based on LFD action-card flowchart, and only 5 of 95 false-negative LFD results were inappropriately admitted to non-COVID-19 areas where no onward-transmission was identified. LFD testing was restricted to asymptomatic patients when disease prevalence fell below 5% and detected 1-3 cases/week.
Universal SARS-CoV-2 LFD testing can be safely and effectively deployed in ED alongside POC-RT-PCR testing during periods of high and low disease prevalence.
急诊科（ED）的即时护理（POC）严重急性呼吸综合征冠状病毒2（SARS-CoV-2）侧向流动抗原检测（LFD）可指导快速感染控制决策，但安全部署的要求尚未完全明确。
回顾在SARS-CoV-2高流行期的两周以及随后几个月流行率下降期间的LFD检测结果、实验室和POC逆转录聚合酶链反应（RT-PCR）结果以及急诊科绩效指标。
确定LFD检测是否可在急诊科安全部署，以提供有效的通用SARS-CoV-2检测能力。
在为期两周的通用LFD评估期内，93%（345/371）的新冠肺炎患者在离开急诊科时获得了病毒学诊断，而在仅进行有针对性的POC-RT-PCR检测时这一比例为77%，在此背景下，约三分之一的患者在就诊时已有英国国家医疗服务体系（NHS）追踪与追溯RT-PCR检测结果。LFD的敏感性和特异性分别为70.7%和99.1%，在疾病患病率为34.7%时，阳性预测值为97.7%，阴性预测值为86.4%。与之前的POC-RT-PCR时期相比，由新冠肺炎导致的急诊科出院延迟（违规）降至33/3532（0.94%），之前为107/4114（2.6%）；p<0.0001。重要的是，LFD检测每天发现1或2例临床未怀疑的新冠肺炎患者。根据LFD行动卡流程图，对3例临床确诊的LFD假阳性患者进行了适当分诊，95例假阴性LFD结果中只有5例被不恰当地收治到未发现进一步传播的非新冠肺炎区域。当疾病患病率降至5%以下时，LFD检测仅限于无症状患者，每周检测到1 - 3例病例。
在疾病高流行期和低流行期，通用的SARS-CoV-2 LFD检测可与POC-RT-PCR检测一起在急诊科安全有效地部署。
