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Performance of the Innova SARS-CoV-2 antigen rapid lateral flow test in the Liverpool asymptomatic testing pilot: population based cohort study
The BMJ ( IF 105.7 ) Pub Date : 2021-07-07 , DOI: 10.1136/bmj.n1637
Marta García-Fiñana 1 , David M Hughes 2 , Christopher P Cheyne 2 , Girvan Burnside 2 , Mark Stockbridge 3 , Tom A Fowler 3, 4 , Veronica L Fowler 3 , Mark H Wilcox 5 , Malcolm G Semple 6, 7 , Iain Buchan 8
Affiliation  

Objective To assess the performance of the SARS-CoV-2 antigen rapid lateral flow test (LFT) versus polymerase chain reaction testing in the asymptomatic general population attending testing centres. Design Observational cohort study. Setting Community LFT pilot at covid-19 testing sites in Liverpool, UK. Participants 5869 asymptomatic adults (≥18 years) voluntarily attending one of 48 testing sites during 6-29 November 2020. Interventions Participants were tested using both an Innova LFT and a quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) test based on supervised self-administered swabbing at testing sites. Main outcome measures Sensitivity, specificity, and predictive values of LFT compared with RT-qPCR in an epidemic steady state of covid-19 among adults with no classic symptoms of the disease. Results Of 5869 test results, 22 (0.4%) LFT results and 343 (5.8%) RT-qPCR results were void (that is, when the control line fails to appear within 30 minutes). Excluding the void results, the LFT versus RT-qPCR showed a sensitivity of 40.0% (95% confidence interval 28.5% to 52.4%; 28/70), specificity of 99.9% (99.8% to 99.99%; 5431/5434), positive predictive value of 90.3% (74.2% to 98.0%; 28/31), and negative predictive value of 99.2% (99.0% to 99.4%; 5431/5473). When the void samples were assumed to be negative, a sensitivity was observed for LFT of 37.8% (26.8% to 49.9%; 28/74), specificity of 99.6% (99.4% to 99.8%; 5431/5452), positive predictive value of 84.8% (68.1% to 94.9%; 28/33), and negative predictive value of 93.4% (92.7% to 94.0%; 5431/5814). The sensitivity in participants with an RT-qPCR cycle threshold (Ct) of <18.3 (approximate viral loads >106 RNA copies/mL) was 90.9% (58.7% to 99.8%; 10/11), a Ct of <24.4 (>104 RNA copies/mL) was 69.4% (51.9% to 83.7%; 25/36), and a Ct of >24.4 (<104 RNA copies/mL) was 9.7% (1.9% to 23.7%; 3/34). LFT is likely to detect at least three fifths and at most 998 in every 1000 people with a positive RT-qPCR test result with high viral load. Conclusions The Innova LFT can be useful for identifying infections among adults who report no symptoms of covid-19, particularly those with high viral load who are more likely to infect others. The number of asymptomatic adults with lower Ct (indicating higher viral load) missed by LFT, although small, should be considered when using single LFT in high consequence settings. Clear and accurate communication with the public about how to interpret test results is important, given the chance of missing some cases, even at high viral loads. Further research is needed to understand how infectiousness is reflected in the viral antigen shedding detected by LFT versus the viral loads approximated by RT-qPCR. Data sharing: Data are accessible through Combined Intelligence for Population Health Action. Requests can be made to the data access committee for extracts of the larger scale data, which cannot be released openly owing to information governance requirements. All R code is accessible from the corresponding author.

中文翻译:

Innova SARS-CoV-2 抗原快速横向流动测试在利物浦无症状测试试点中的表现:基于人群的队列研究

目的 评估 SARS-CoV-2 抗原快速侧向流动检测 (LFT) 与聚合酶链反应检测在无症状普通人群参加检测中心的性能。设计观察性队列研究。在英国利物浦的 covid-19 测试站点设置社区 LFT 试点。参与者 5869 名无症状成人(≥18 岁)在 2020 年 11 月 6 日至 29 日期间自愿参加 48 个测试站点之一。干预 参与者使用 Innova LFT 和基于监督的定量逆转录酶聚合酶链反应 (RT-qPCR) 测试进行测试在测试地点自行进行擦拭。主要结果测量在没有典型疾病症状的成年人中,在 COVID-19 流行稳定状态下,LFT 与 RT-qPCR 相比的敏感性、特异性和预测值。结果 5869 份检测结果中,22 份(0.4%)LFT 结果和 343 份(5.8%)RT-qPCR 结果无效(即当控制线未能在 30 分钟内出现时)。排除无效结果,LFT 与 RT-qPCR 的敏感性为 40.0%(95% 置信区间 28.5% 至 52.4%;28/70),特异性为 99.9%(99.8% 至 99.99%;5431/5434),阳性预测值为 90.3%(74.2% 至 98.0%;28/31),阴性预测值为 99.2%(99.0% 至 99.4%;5431/5473)。当假设无效样本为阴性时,观察到 LFT 的敏感性为 37.8%(26.8% 至 49.9%;28/74),特异性为 99.6%(99.4% 至 99.8%;5431/5452),阳性预测值84.8%(68.1% 至 94.9%;28/33),阴性预测值为 93.4%(92.7% 至 94.0%;5431/5814)。RT-qPCR 循环阈值 (Ct) <18 的参与者的敏感性。3(大约病毒载量 >106 RNA 拷贝/mL)为 90.9%(58.7% 至 99.8%;10/11),Ct <24.4(>104 RNA 拷贝/mL)为 69.4%(51.9% 至 83.7%; 25/36),>24.4(<104 RNA 拷贝/mL)的 Ct 为 9.7%(1.9% 至 23.7%;3/34)。LFT 可能会在每 1000 名 RT-qPCR 检测结果呈阳性且病毒载量高的人中检测到至少五分之三,最多 998 人。结论 Innova LFT 可用于识别没有报告 covid-19 症状的成年人的感染,特别是那些病毒载量高且更有可能感染他人的人。LFT 遗漏的 Ct 较低(表明病毒载量较高)的无症状成人的数量虽然很少,但在高后果环境中使用单一 LFT 时应予以考虑。与公众就如何解释测试结果进行清晰准确的沟通很重要,即使在病毒载量很高的情况下,也有可能漏掉一些病例。需要进一步的研究来了解传染性如何反映在 LFT 检测到的病毒抗原脱落与 RT-qPCR 近似的病毒载量之间。数据共享:数据可通过人口健康行动联合情报访问。可向数据访问委员会提出请求,提取更大规模的数据,由于信息治理要求,这些数据不能公开发布。所有 R 代码都可以从相应的作者处获得。数据可通过人口健康行动的综合情报访问。可向数据访问委员会提出请求,提取更大规模的数据,由于信息治理要求,这些数据不能公开发布。所有 R 代码都可以从相应的作者处获得。数据可通过人口健康行动的综合情报访问。可向数据访问委员会提出请求,提取更大规模的数据,由于信息治理要求,这些数据不能公开发布。所有 R 代码都可以从相应的作者处获得。
更新日期:2021-07-07
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