Ellis Jayne E, Guest Poppy, Lawson Vicki, Loecherbach Julia, Lindner Nigel, McCulloch Andrew
LumiraDx Ltd, Stirling, UK.
LumiraDx Ltd, 3 More London Riverside, London, SE1 2AQ, UK.
Infect Dis Ther. 2022 Dec;11(6):2099-2109. doi: 10.1007/s40121-022-00696-8. Epub 2022 Sep 24.
Coronavirus disease 2019 (COVID-19) and influenza share similar symptoms, which hampers diagnosis. Given that they require different containment and treatment strategies, fast and accurate distinction between the two infections is needed. This study evaluates the sensitivity and specificity of the microfluidic antigen LumiraDx SARS-CoV-2 and Flu A/B Test for simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B from a single nasal swab.
Nasal samples were collected from patients as part of the ASPIRE (NCT04557046) and INSPIRE (NCT04288921) studies at point-of-care testing sites in the USA. ASPIRE study participants were included after developing COVID-19 symptoms in the last 14 days or following a positive SARS-CoV-2 test in the last 48 h. INSPIRE study participants were included after developing influenza symptoms in the last 4 days. Samples were extracted into proprietary buffer and analysed using the LumiraDx SARS-CoV-2 and Flu A/B Test. A reference sample was taken from each subject, placed into universal transport medium and tested using reference SARS-CoV-2 and influenza reverse transcription polymerase chain reaction (RT-PCR) tests. The test and reference samples were compared using the positive percent agreement (PPA) and negative percent agreement (NPA), together with their 95% confidence intervals (CIs).
Analysis of the data from the ASPIRE (N = 124) and INSPIRE (N = 159) studies revealed high levels of agreement between the LumiraDx SARS-CoV-2 and Flu A/B Test and the reference tests in detecting SARS-CoV-2 (PPA = 95.5% [95% CI 84.9%, 98.7%]; NPA = 96.0% [95% CI 90.9%, 98.3%]), influenza A (PPA = 83.3% [95% CI 66.4%, 92.7%]; NPA = 97.7% [95% CI 93.4%, 99.2%]) and influenza B (PPA = 80.0% [95% CI 62.7%, 90.5%]; NPA = 95.3% [95% CI 90.2%, 97.9%]).
The LumiraDx SARS-CoV-2 and Flu A/B Test shows a high agreement with the reference RT-PCR tests while simultaneously detecting and differentiating between SARS-CoV-2 and influenza A/B.
ClinicalTrials.gov identifiers NCT04557046 and NCT04288921.
2019年冠状病毒病（COVID-19）和流感有相似症状，这妨碍了诊断。鉴于它们需要不同的防控和治疗策略，因此需要快速、准确地区分这两种感染。本研究评估了微流控抗原LumiraDx SARS-CoV-2和流感A/B检测法从单一鼻拭子中同时检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）和流感A/B的敏感性和特异性。
作为美国即时检测点的ASPIRE（NCT04557046）和INSPIRE（NCT04288921）研究的一部分，从患者中采集鼻拭子样本。ASPIRE研究的参与者是在过去14天内出现COVID-19症状或在过去48小时内SARS-CoV-2检测呈阳性之后纳入的。INSPIRE研究的参与者是在过去4天内出现流感症状之后纳入的。样本被提取到专用缓冲液中，并使用LumiraDx SARS-CoV-2和流感A/B检测法进行分析。从每个受试者采集一份参考样本，置于通用运输培养基中，并使用参考SARS-CoV-2和流感逆转录聚合酶链反应（RT-PCR）检测法进行检测。使用阳性百分一致性（PPA）和阴性百分一致性（NPA）及其95%置信区间（CI）对检测样本和参考样本进行比较。
对ASPIRE（N = 124）和INSPIRE（N = 159）研究的数据进行分析后发现，LumiraDx SARS-CoV-2和流感A/B检测法与参考检测法在检测SARS-CoV-2方面具有高度一致性（PPA = 95.5% [95% CI 84.9%，98.7%]；NPA = 96.0% [95% CI 90.9%，98.3%]），在检测甲型流感方面（PPA = 83.3% [95% CI 66.4%，9
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