Institute of Virology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; German Centre for Infection Research, Berlin, Germany.
Institute of Virology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Lancet Microbe. 2021 Jul;2(7):e311-e319. doi: 10.1016/S2666-5247(21)00056-2. Epub 2021 Apr 7.
Antigen point-of-care tests (AgPOCTs) can accelerate SARS-CoV-2 testing. As some AgPOCTs have become available, interest is growing in their utility and performance. Here we aimed to compare the analytical sensitivity and specificity of seven commercially available AgPOCT devices.
In a single-centre, laboratory evaluation study, we compared AgPOCT products from seven suppliers: the Abbott Panbio COVID-19 Ag Rapid Test, the RapiGEN BIOCREDIT COVID-19 Ag, the Healgen Coronavirus Ag Rapid Test Cassette (Swab), the Coris BioConcept COVID-19 Ag Respi-Strip, the R-Biopharm RIDA QUICK SARS-CoV-2 Antigen, the nal von minden NADAL COVID-19 Ag Test, and the Roche-SD Biosensor SARS-CoV Rapid Antigen Test. Tests were evaluated on recombinant SARS-CoV-2 nucleoprotein, cultured endemic and emerging coronaviruses, stored respiratory samples with known SARS-CoV-2 viral loads, stored samples from patients with respiratory pathogens other than SARS-CoV-2, and self-sampled swabs from healthy volunteers. We estimated analytical sensitivity in terms of approximate viral concentrations (quantified by real-time RT-PCR) that yielded positive AgPOCT results, and specificity in terms of propensity to generate false-positive results.
In 138 clinical samples with quantified SARS-CoV-2 viral load, the 95% limit of detection (concentration at which 95% of test results were positive) in six of seven AgPOCT products ranged between 2·07 × 10 and 2·86 × 10 copies per swab, with an outlier (RapiGEN) at 1·57 × 10 copies per swab. The assays showed no cross-reactivity towards cell culture or tissue culture supernatants containing any of the four endemic human coronaviruses (HCoV‑229E, HCoV‑NL63, HCoV‑OC43, or HCoV‑HKU1) or MERS-CoV, with the exception of the Healgen assay in one repeat test on HCoV-HKU1 supernatant. SARS-CoV was cross-detected by all assays. Cumulative specificities among stored clinical samples with non-SARS-CoV-2 infections (n=100) and self-samples from healthy volunteers (n=35; cumulative sample n=135) ranged between 98·5% (95% CI 94·2-99·7) and 100·0% (97·2-100·0) in five products, with two outliers at 94·8% (89·2-97·7; R-Biopharm) and 88·9% (82·1-93·4; Healgen). False-positive results did not appear to be associated with any specific respiratory pathogen.
The sensitivity range of most AgPOCTs overlaps with SARS-CoV-2 viral loads typically observed in the first week of symptoms, which marks the infectious period in most patients. The AgPOCTs with limit of detections that approximate virus concentrations at which patients are infectious might enable shortcuts in decision making in various areas of health care and public health.
EU's Horizon 2020 research and innovation programme, German Ministry of Research, German Federal Ministry for Economic Affairs and Energy, German Ministry of Health, and Bill & Melinda Gates Foundation.
抗原即时检测（AgPOCT）可加速 SARS-CoV-2 的检测。随着一些 AgPOCT 的出现，人们对其效用和性能的兴趣日益增加。在此，我们旨在比较七种市售 AgPOCT 设备的分析灵敏度和特异性。
在一项单中心实验室评估研究中，我们比较了来自 7 家供应商的 AgPOCT 产品：Abbott Panbio COVID-19 Ag 快速检测试剂盒、RapiGEN BIOCREDIT COVID-19 Ag、Healgen 冠状病毒 Ag 快速检测试剂盒（拭子）、Coris BioConcept COVID-19 Ag Respi-Strip、R-Biopharm RIDA QUICK SARS-CoV-2 抗原、nal von minden NADAL COVID-19 Ag 检测试剂盒和 Roche-SD Biosensor SARS-CoV 快速抗原检测试剂盒。这些检测试剂盒分别在重组 SARS-CoV-2 核蛋白、培养的地方和新兴冠状病毒、具有已知 SARS-CoV-2 病毒载量的储存呼吸道样本、储存的非 SARS-CoV-2 呼吸道病原体患者样本以及来自健康志愿者的自我采样拭子上进行了评估。我们根据产生阳性 AgPOCT 结果的近似病毒浓度（通过实时 RT-PCR 定量）来估计分析灵敏度，并根据产生假阳性结果的倾向来估计特异性。
在 138 份具有定量 SARS-CoV-2 病毒载量的临床样本中，七种 AgPOCT 产品中的六种在 2.07×10 和 2.86×10 个拷贝/拭子之间的 95%检测限（产生 95%检测结果阳性的浓度），一个产品（RapiGEN）的检测限为 1.57×10 个拷贝/拭子。这些检测试剂盒对含有四种地方人类冠状病毒（HCoV-229E、HCoV-NL63、HCoV-OC43 或 HCoV-HKU1）或 MERS-CoV 的细胞培养或组织培养上清液没有交叉反应性，除了在一个重复试验中 Healgen 检测试剂盒对 HCoV-HKU1 上清液有一个检测结果。所有检测试剂盒都能检测到 SARS-CoV。在非 SARS-CoV-2 感染的储存临床样本（n=100）和来自健康志愿者的自我样本（n=35；累积样本 n=135）中，五种产品的累积特异性在 98.5%（95%CI 94.2-99.7）和 100.0%（97.2-100.0）之间，两种产品的特异性为 94.8%（89.2-97.7；R-Biopharm）和 88.9%（82.1-93.4；Healgen）。假阳性结果似乎与任何特定的呼吸道病原体无关。
大多数 AgPOCT 的灵敏度范围与大多数患者感染期的症状出现后的第一周内通常观察到的 SARS-CoV-2 病毒载量相重叠。那些检测限接近患者具有传染性的病毒浓度的 AgPOCT 可能会使医疗保健和公共卫生领域的各种决策变得更加快捷。
该研究由欧盟地平线 2020 研究和创新计划、德国研究部、德国联邦经济事务和能源部、德国卫生部和比尔及梅琳达·盖茨基金会共同资助。
