Comparison of SARS-CoV-2 serological tests with different antigen targets.

Comparison of SARS-CoV-2 serological tests with different antigen targets.
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DOI:
10.1016/j.jcv.2020.104690
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发表时间:
2021-01
期刊:
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子:
--
通讯作者:
Croxatto A
Croxatto A
中科院分区:
其他
文献类型:
--
作者:
Coste AT;Jaton K;Papadimitriou-Olivgeris M;Greub G;Croxatto A

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在过去的几个月里,已经有几十种SARS-CoV-2血清学检测方法,它们的性能各不相同。瑞士完成了一项重大工作,对2020年4月可用的17种血清学检测进行了比较。在初步阶段,我们比较了182份血清中的17种IgG、IgM、IgA和pan Ig血清学检测,包括ELISA、LFA、CLIA和ECLIA,其中113份来自RT-PCR阳性住院患者的血清,69份来自2019年11月1日之前的样本,预计分别给出阳性和阴性结果。在第二阶段,对总共582份血清(分别为178份和404份预期呈阳性和阴性)进一步评估了表现最好和最可用的5种检测方法,从而评估了20种可能与其他病毒发生的交叉反应。在初步阶段,8项IgG/pan-Ig ELISA或CLIA/ECLIA检测中,5项检测的敏感性和特异性分别高于90%和98%,6项IgM/IgA检测中,只有1项可接受。只有一种LFA检测对IgG和IgM均有良好的效果。所有试验均伴有IgM和IgG的出现。在第二阶段,没有测试显示出特别的交叉反应。我们在抗体反应的发展中观察到一个重要的异质性。在检测中至危重病人的血清学反应时,大多数评估的检测方法表现出较高的IgG/pan-Ig敏感性和特异性。在本研究中,IgM和IgA检测大多表现不佳,对测试队列的早期诊断没有附加价值。
These last months, dozens of SARS-CoV-2 serological tests have become available with varying performances. A major effort was completed to compare 17 serological tests available in April 2020 in Switzerland. In a preliminary phase, we compared 17 IgG, IgM, IgA and pan Ig serological tests including ELISA, LFA, CLIA and ECLIA on a panel of 182 sera, comprising 113 sera from hospitalized patients with a positive RT-PCR, and 69 sampled before 1st November 2019, expected to give a positive and negative results, respectively. In a second phase, the five best performing and most available tests were further evaluated on a total of 582 sera (178 and 404 expected positive and negative, respectively), allowing the assessment of 20 possible cross-reactions with other viruses. In the preliminary phase, among eight IgG/pan-Ig ELISA or CLIA/ECLIA tests, five had a sensitivity and specificity above 90 % and 98 % respectively, and on six IgM/IgA tests, only one was acceptable. Only one LFA test on three showed good performances for both IgG and IgM. For all the tests IgM and IgG aroused concomitantly. In the second phase, no test showed particular cross-reaction. We observed an important heterogeneity in the development of the antibody response. The majority of the evaluated tests exhibited high performances of IgG/pan-Ig sensitivity and specificity to detect the serological response of moderately to critically ill hospitalized patients. The IgM and IgA tests showed mostly insufficient performances with no added value for the early diagnostic on the cohort tested in this study.
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