Target specific serologic analysis of COVID-19 convalescent plasma.
Target specific serologic analysis of COVID-19 convalescent plasma.
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DOI：
10.1371/journal.pone.0249938
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Gniadek TJ
中科院分区：
文献类型：
--
作者：
Ikegami S;Benirschke RC;Fakhrai-Rad H;Motamedi MH;Hockett R;David S;Lee HK;Kang J;Gniadek TJ
本研究比较了 2019 年冠状病毒病 (COVID-19) 的四种血清学检测的性能，并调查了 COVID-19 病史与检测性能是否相关。在 Northshore 使用 Elecsys Anti-SARS-CoV-2 (Roche Diagnostics)、Access SARS-CoV-2 IgG anti-RBD (Beckman Coulter) 和 LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) 以及在 Genalyte 使用 Maverick 多抗原血清学面板对样本进行了测试。该研究包括 2019 年 12 月之前收集的 100 份临床样本，以及从最初通过 PCR 诊断为 COVID-19 的恢复期血浆捐献者收集的 97 份样本。 COVID-19 病史由血浆捐献者自行报告。测试的测定之间的特异性没有差异。这四项测试的临床敏感性分别为 98% (Genalyte)、96% (Roche)、92% (DiaSorin) 和 87% (Beckman)。临床敏感性方面唯一具有统计学显着性差异的是 Beckman 测定法与 Genalyte 和 Roche 测定法之间的差异。恢复期血浆供体特征和疾病症状与贝克曼和迪亚索林检测的假阴性结果无关。所有四项测试均显示出高特异性 (100%) 和不同的敏感性 (89-98%)。没有观察到疾病史和血清学结果之间的相关性。 Genalyte Multiplex 检测方法与之前经 FDA 紧急使用授权验证的其他三种检测方法相比，表现出良好或更好的灵敏度。
This study compared the performance of four serology assays for Coronavirus Disease 2019 (COVID-19) and investigated whether COVID-19 disease history correlates with assay performance. Samples were tested at Northshore using the Elecsys Anti-SARS-CoV-2 (Roche Diagnostics), Access SARS-CoV-2 IgG anti-RBD (Beckman Coulter), and LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) as well as at Genalyte using Maverick Multi-Antigen Serology Panel. The study included one hundred clinical samples collected before December 2019 and ninety-seven samples collected from convalescent plasma donors originally diagnosed with COVID-19 by PCR. COVID-19 disease history was self-reported by the plasma donors. There was no difference in specificity between the assays tested. Clinical sensitivity of these four tests was 98% (Genalyte), 96% (Roche), 92% (DiaSorin), and 87% (Beckman). The only statistically significant differences in clinical sensitivity was between the Beckman assay and both Genalyte and Roche assays. Convalescent plasma donor characteristics and disease symptoms did not correlate with false negative results from the Beckman and DiaSorin assays. All four tests showed high specificity (100%) and varying sensitivities (89–98%). No correlations between disease history and serology results were observed. The Genalyte Multiplex assay showed as good or better sensitivity to three other previously validated assays with FDA Emergency Use Authorizations.
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DOI：
10.1001/jama.2020.7869
发表时间：
2020-06-09
期刊：
JAMA
影响因子：
--
作者：
Kirkcaldy RD;King BA;Brooks JT
通讯作者：
Brooks JT
影响因子：
2.2
作者：
Mudumba, Sasi;de Alba, Sophia;Burlingame, Rufus W.
通讯作者：
Burlingame, Rufus W.
DOI：
10.1016/j.bjoms.2020.06.021
发表时间：
2020-10-01
影响因子：
1.8
作者：
Herron, J. B. T.;Dennis, J.;Brennan, P. A.
通讯作者：
Brennan, P. A.
影响因子：
24.3
作者：
Lou, Bin;Li, Ting-Dong;Chen, Yu
通讯作者：
Chen, Yu
影响因子：
64.5
作者：
Hoffmann, Markus;Kleine-Weber, Hannah;Poehlmann, Stefan
通讯作者：
Poehlmann, Stefan