Big Data Institute, Nuffield Department of Population Health, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK; NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, University of Oxford, Oxford, UK.
UK Health Security Agency, London, UK; School of Biomedical Sciences, Faculty of Health, University of Plymouth, Plymouth, UK.
Lancet Infect Dis. 2023 Aug;23(8):922-932. doi: 10.1016/S1473-3099(23)00129-9. Epub 2023 Mar 28.
Antigen lateral flow devices (LFDs) have been widely used to control SARS-CoV-2. We aimed to improve understanding of LFD performance with changes in variant infections, vaccination, viral load, and LFD use, and in the detection of infectious individuals.
In this diagnostic study, paired LFD and RT-PCR test results were prospectively collected from asymptomatic and symptomatic participants in the UK between Nov 4, 2020, and March 21, 2022, to support the National Health Service (NHS) England's Test and Trace programme. The LFDs evaluated were the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the Orient Gene Rapid Covid-19 (Antigen) Self-Test, and the Acon Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). Test results were collected across various community testing settings, including predeployment testing sites, routine testing centres, homes, schools, universities, workplaces, targeted community testing, and from health-care workers. We used multivariable logistic regression to analyse LFD sensitivity and specificity using RT-PCR as a reference standard, adjusting for viral load, LFD manufacturer, test setting, age, sex, test assistance, symptom status, vaccination status, and SARS-CoV-2 variant. National contact tracing data from NHS Test and Trace (Jan 1, 2021, to Jan 11, 2022) were used to estimate the proportion of transmitting index patients (with ≥1 RT-PCR-positive or LFD-positive contact) potentially detectable by LFDs (specifically Innova, as the most widely used LFD) with time, accounting for index viral load, variant, and symptom status.
We assessed 75 382 pairs of LFD and RT-PCR tests. Of these, 4131 (5·5%) were RT-PCR-positive. LFD sensitivity versus RT-PCR was 63·2% (95% CI 61·7-64·6) and specificity was 99·71% (95% CI 99·66-99·74). Increased viral load was independently associated with being LFD positive (adjusted odds ratio [aOR] 2·85 [95% CI 2·66-3·06] per 1 log copies per mL increase; p<0·0001). There was no evidence that LFD sensitivity differed for delta (B.1.617.2) infections versus alpha (B.1.1.7) or pre-alpha (B.1.177) infections (aOR 1·00 [0·69-1·45]; p=0·99), whereas omicron (BA.1 or BA.2) infections appeared more likely to be LFD positive (aOR 1·63 [1·02-2·59]; p=0·042). Sensitivity was higher in symptomatic participants (68·7% [95% CI 66·9-70·4]) than in asymptomatic participants (52·8% [50·1-55·4]). Among 347 374 unique index patients with probable onward transmission, 78·3% (95% CI 75·3-81·2) were estimated to have been detectable with LFDs (Innova), and this proportion was mostly stable with time and for successive variants. Overall, the estimated proportion of infectious index patients detectable by the Innova LFD was lower in asymptomatic patients (57·6% [53·6-61·9]) versus symptomatic patients (79·7% [76·7-82·5]).
LFDs remained able to detect most SARS-CoV-2 infections throughout vaccine roll-out and across different viral variants. LFDs can potentially detect most infections that transmit to others and reduce the risk of transmission. However, performance is lower in asymptomatic individuals than in symptomatic individuals.
UK Health Security Agency, the UK Government Department of Health and Social Care, National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, and the University of Oxford NIHR Biomedical Research Centre.
抗原侧向流动设备（LFD）已广泛用于控制 SARS-CoV-2。我们旨在通过变体感染、疫苗接种、病毒载量和 LFD 使用的变化，以及对传染性个体的检测，提高对 LFD 性能的理解。
在这项诊断研究中，我们前瞻性地从英国无症状和有症状的参与者那里收集了 LFD 和 RT-PCR 测试结果，从 2020 年 11 月 4 日至 2022 年 3 月 21 日，以支持英国国民保健制度（NHS）英格兰的测试和追踪计划。评估的 LFD 是 Innova SARS-CoV-2 抗原快速定性测试、东方基因快速 Covid-19（抗原）自测和 Acon Flowflex SARS-CoV-2 抗原快速测试（自测）。测试结果是在各种社区测试环境中收集的，包括部署前测试点、常规测试中心、家庭、学校、大学、工作场所、有针对性的社区测试和医护人员。我们使用多变量逻辑回归分析了 LFD 的敏感性和特异性，使用 RT-PCR 作为参考标准，调整了病毒载量、LFD 制造商、测试环境、年龄、性别、测试辅助、症状状态、疫苗接种状态和 SARS-CoV-2 变体。利用 NHS 测试和追踪（2021 年 1 月 1 日至 2022 年 1 月 11 日）的国家接触者追踪数据，估计了 Innova（最广泛使用的 LFD）等 LFD 检测到有潜在传染性的指数患者（≥1 个 RT-PCR 阳性或 LFD 阳性接触者）的比例，同时考虑了指数病毒载量、变体和症状状态。
我们评估了 75382 对 LFD 和 RT-PCR 测试。其中，4131 例（5.5%）为 RT-PCR 阳性。与 RT-PCR 相比，LFD 的敏感性为 63.2%（95%CI 61.7-64.6），特异性为 99.71%（95%CI 99.66-99.74）。病毒载量的增加与 LFD 阳性独立相关（调整后的优势比[aOR]每 1 对数增加 2.85 [95%CI 2.66-3.06]；p<0.0001）。没有证据表明 delta（B.1.617.2）感染与 alpha（B.1.1.7）或 pre-alpha（B.1.177）感染的 LFD 敏感性不同（aOR 1.00 [0.69-1.45]；p=0.99），而 omicron（BA.1 或 BA.2）感染似乎更有可能为 LFD 阳性（aOR 1.63 [1.02-2.59]；p=0.042）。在有症状的参与者中，敏感性（68.7%[95%CI 66.9-70.4]）高于无症状参与者（52.8%[50.1-55.4]）。在 347374 名具有潜在传播能力的独特指数患者中，估计 78.3%（95%CI 75.3-81.2%）可以通过 LFD（Innova）检测到，而且随着时间的推移和不同变体的出现，这个比例基本保持稳定。总体而言，无症状患者中，Innova LFD 检测到的传染性指数患者的比例（57.6%[53.6-61.9]）低于有症状患者（79.7%[76.7-82.5]）。
LFD 在疫苗推出和不同病毒变体期间仍能检测到大多数 SARS-CoV-2 感染。LFD 可以潜在地检测到大多数传染给他人的感染，并降低传播的风险。然而，无症状患者的性能低于有症状患者。
英国卫生安全局、英国卫生部和社会保健部、国家卫生研究院（NIHR）与医疗保健相关感染和抗生素耐药性相关的卫生保健相关感染预防和控制研究单位以及牛津大学 NIHR 生物医学研究中心。
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