The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro.
The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro.
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DOI：
10.3390/jcm10020328
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发表时间：
2021-01-17
影响因子：
3.9
通讯作者：
Rabenau HF
中科院分区：
文献类型：
--
作者：
Kohmer N;Toptan T;Pallas C;Karaca O;Pfeiffer A;Westhaus S;Widera M;Berger A;Hoehl S;Kammel M;Ciesek S;Rabenau HF
由于全球严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）感染人数不断上升，基于实时逆转录聚合酶链反应（rRT-PCR）的检测资源已经耗尽。为满足检测需求和减少传播，正在考虑采用SARS-CoV-2抗原检测快速诊断测试（Ag-RDTs）。这些检测快速、廉价且使用简单，但它们是否能检测到潜在的传染性病例尚未得到很好的研究。我们使用100份临床样本评估了三种侧流检测（RIDA®QUICK SARS-CoV-2抗原检测（R-Biopharm）、SARS-CoV-2快速抗原检测（罗氏））和纳达尔®COVID-19抗原检测（Nal von Minden GmbH，德国雷根斯堡）和一种微流控免疫荧光检测（SARS-CoV-2抗原检测（LumiraDx GmbH，德国科隆））。诊断性rRT-PCR和细胞培养检测作为感染性标志物同时进行。对于rrt - pcr阳性样本，Ag-RDT的总体敏感性在24.3%至50%之间。然而，对于病毒载量超过6 log10 RNA拷贝/mL（22/100）的样本（通常见于感染性个体），Ag-RDT阳性在81.8%至100%之间。只有51.6%（33/64）的rrt - pcr阳性样本在细胞培养中具有传染性。相比之下，三个ag - rdt与细胞培养感染性的相关性更为显著（61.8-82.4%）。我们的研究结果表明，可以考虑大规模的基于SARS-CoV-2 ag - rdt的检测来检测潜在的感染个体并减少病毒的传播。
Due to globally rising numbers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, resources for real-time reverse-transcription polymerase chain reaction (rRT-PCR)-based testing have been exhausted. In order to meet the demands of testing and reduce transmission, SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs) are being considered. These tests are fast, inexpensive, and simple to use, but whether they detect potentially infectious cases has not been well studied. We evaluated three lateral flow assays (RIDA®QUICK SARS-CoV-2 Antigen (R-Biopharm), SARS-CoV-2 Rapid Antigen Test (Roche)), and NADAL® COVID-19 Ag Test (Nal von Minden GmbH, Regensburg, Germany) and one microfluidic immunofluorescence assay (SARS-CoV-2 Ag Test (LumiraDx GmbH, Cologne, Germany)) using 100 clinical samples. Diagnostic rRT-PCR and cell culture testing as a marker for infectivity were performed in parallel. The overall Ag-RDT sensitivity for rRT-PCR-positive samples ranged from 24.3% to 50%. However, for samples with a viral load of more than 6 log10 RNA copies/mL (22/100), typically seen in infectious individuals, Ag-RDT positivity was between 81.8% and 100%. Only 51.6% (33/64) of the rRT-PCR-positive samples were infectious in cell culture. In contrast, three Ag-RDTs demonstrated a more significant correlation with cell culture infectivity (61.8–82.4%). Our findings suggest that large-scale SARS-CoV-2 Ag-RDT-based testing can be considered for detecting potentially infective individuals and reducing the virus spread.
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影响因子：
11.8
作者：
Perera RAPM;Tso E;Tsang OTY;Tsang DNC;Fung K;Leung YWY;Chin AWH;Chu DKW;Cheng SMS;Poon LLM;Chuang VWM;Peiris M
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作者：
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DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
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影响因子：
1.9
作者：
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通讯作者：
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DOI：
10.1001/jama.2020.21694
发表时间：
2020-12-01
期刊：
JAMA
影响因子：
--
作者：
Manabe YC;Sharfstein JS;Armstrong K
通讯作者：
Armstrong K