Limited specificity of commercially available SARS-CoV-2 IgG ELISAs in serum samples of African origin.

Limited specificity of commercially available SARS-CoV-2 IgG ELISAs in serum samples of African origin.
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DOI:
10.1111/tmi.13569
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发表时间:
2021-06
期刊:
Tropical medicine & international health : TM & IH
影响因子:
--
通讯作者:
Deschermeier C
Deschermeier C
中科院分区:
其他
文献类型:
--
作者:
Emmerich P;Murawski C;Ehmen C;von Possel R;Pekarek N;Oestereich L;Duraffour S;Pahlmann M;Struck N;Eibach D;Krumkamp R;Amuasi J;Maiga-Ascofaré O;Rakotozandrindrainy R;Asogun D;Ighodalo Y;Kann S;May J;Tannich E;Deschermeier C

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特异性血清学检测对于可靠的SARS-CoV-2诊断和血清阳性率研究是强制性的。在此,我们评估了四种市售SARS-CoV-2 IgG ELISA在来自非洲、南美和欧洲的血清/血浆样本组中的特异性。采用三种基于核衣壳的ELISA(Euroimmun抗SARS-CoV-2-NCP IgG、EDI™新型冠状病毒COVID-19 IgG、Mikrogen recomWell SARS-CoV-2 IgG)、一种基于加标/S1的ELISA(Euroimmun抗SARS-CoV-2 IgG)和内部普通感冒CoV ELISA,分析了在COVID-19大流行之前从三个非洲国家(加纳、马达加斯加、尼日利亚)、哥伦比亚和德国的无症状供体中采集的882份血清/血浆样本。对于马达加斯加(93.4-99.4%)、哥伦比亚(97.8-100.0%)和德国(95.9-100.0%)样本,证实了所有SARS-CoV-2 IgG ELISA的高特异性。相比之下,加纳和尼日利亚血清样本组的特异性要低得多(加纳:基于NCP的检测试剂盒为77.7- 89.7%,基于加标物/S1的检测试剂盒为94.3%;尼日利亚:基于NCP的检测试剂盒为39.3- 82.7%,基于加标物/S1的检测试剂盒为90.7%)。在基于NCP和基于加标/S1的Euroimmun ELISA中,600份非洲血清中有15份一致归类为阳性,但在替代病毒中和试验中未抑制加标/ACE 2结合。在所有样本组中均发现了由先前感染普通感冒CoV引起的IgG抗体,包括来自马达加斯加、哥伦比亚和德国的样本组,因此不会不可避免地妨碍检测特异性。然而,在所有15份SARS-CoV-2 NCP/spike/S1 ELISA阳性血清中均发现了高水平的与OC 43 NCP相互作用的IgG抗体。根据所选择的抗原和检测方案,SARS-CoV-2 IgG ELISA特异性在某些人群中可能会显著降低,这可能是由于对地方性病原体(如其他病毒或寄生虫)的免疫反应的干扰。
Specific serological tests are mandatory for reliable SARS‐CoV‐2 diagnostics and seroprevalence studies. Here, we assess the specificities of four commercially available SARS‐CoV‐2 IgG ELISAs in serum/plasma panels originating from Africa, South America, and Europe. 882 serum/plasma samples collected from symptom‐free donors before the COVID‐19 pandemic in three African countries (Ghana, Madagascar, Nigeria), Colombia, and Germany were analysed with three nucleocapsid‐based ELISAs (Euroimmun Anti‐SARS‐CoV‐2‐NCP IgG, EDI™ Novel Coronavirus COVID‐19 IgG, Mikrogen recomWell SARS‐CoV‐2 IgG), one spike/S1‐based ELISA (Euroimmun Anti‐SARS‐CoV‐2 IgG), and in‐house common cold CoV ELISAs. High specificity was confirmed for all SARS‐CoV‐2 IgG ELISAs for Madagascan (93.4–99.4%), Colombian (97.8–100.0%), and German (95.9–100.0%) samples. In contrast, specificity was much lower for the Ghanaian and Nigerian serum panels (Ghana: NCP‐based assays 77.7–89.7%, spike/S1‐based assay 94.3%; Nigeria: NCP‐based assays 39.3–82.7%, spike/S1‐based assay 90.7%). 15 of 600 African sera were concordantly classified as positive in both the NCP‐based and the spike/S1‐based Euroimmun ELISA, but did not inhibit spike/ACE2 binding in a surrogate virus neutralisation test. IgG antibodies elicited by previous infections with common cold CoVs were found in all sample panels, including those from Madagascar, Colombia, and Germany and thus do not inevitably hamper assay specificity. Nevertheless, high levels of IgG antibodies interacting with OC43 NCP were found in all 15 SARS‐CoV‐2 NCP/spike/S1 ELISA positive sera. Depending on the chosen antigen and assay protocol, SARS‐CoV‐2 IgG ELISA specificity may be significantly reduced in certain populations probably due to interference of immune responses to endemic pathogens like other viruses or parasites.
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