Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study.
Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study.
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DOI：
10.1016/s2666-5247(21)00056-2
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发表时间：
2021-07
期刊：
影响因子：
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通讯作者：
Drosten C
中科院分区：
文献类型：
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作者：
Corman VM;Haage VC;Bleicker T;Schmidt ML;Mühlemann B;Zuchowski M;Jo WK;Tscheak P;Möncke-Buchner E;Müller MA;Krumbholz A;Drexler JF;Drosten C
抗原即时检测（AgPOCT）可以加速SARS-CoV-2检测。随着一些AgPOCT的出现，人们对其实用性和性能的兴趣越来越大。在这里，我们的目的是比较分析的灵敏度和特异性的七个市售AgPOCT设备。在一项单中心实验室评价研究中，我们比较了来自七家供应商的AgPOCT产品：Abbott Panbio COVID-19 Ag Rapid Test、RapiGEN BIOCREDIT COVID-19 Ag、Healgen Coronavirus Ag Rapid Test Cassette（拭子）、Coris BioConcept COVID-19 Ag Respi-Strip、R-Biopharm RIDA QUICK SARS-CoV-2 Antigen、nal von明登NADAL COVID-19 Ag Test，Roche-SD生物传感器SARS-CoV快速抗原检测。对重组SARS-CoV-2核蛋白、培养的地方性和新发冠状病毒、储存的已知SARS-CoV-2病毒载量的呼吸道样本、储存的非SARS-CoV-2呼吸道病原体患者样本以及健康志愿者的自采样拭子进行了检测。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）估计分析灵敏度，并根据产生假阳性结果的倾向估计特异性。在138份具有定量SARS-CoV-2病毒载量的临床样本中，7种AgPOCT产品中有6种的95%检测限（95%检测结果为阳性的浓度）范围在2.07 × 106和2.86 × 107拷贝/拭子之间，离群值（RapiGEN）为1.57 × 1010拷贝/拭子。除在对HCoV-HKU 1上清液进行的一次重复检测中的Healgen检测外，检测结果显示，对含有四种地方性人冠状病毒（HCoV-229 E、HCoV-NL 63、HCoV-OC 43或HCoV-HKU 1）或MERS-CoV的细胞培养物或组织培养物上清液无交叉反应性。SARS-CoV被所有检测试剂交叉检测。储存的非SARS-CoV-2感染临床样本（n=100）和健康志愿者自身样本的累积特异性（n=35;累积样本n=135）范围为98.5%（95% CI 94·2-99·7）和100·0%（97·2-100·0），两个离群值分别为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的敏感性范围与通常在症状的第一周观察到的SARS-CoV-2病毒载量重叠，这标志着大多数患者的感染期。AgPOCT的检测限接近患者具有传染性的病毒浓度，这可能会为医疗保健和公共卫生各个领域的决策提供捷径。欧盟的地平线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，德国卫生部和比尔和梅林达盖茨基金会。
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 × 106 and 2·86 × 107 copies per swab, with an outlier (RapiGEN) at 1·57 × 1010 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.