N-protein presents early in blood, dried blood and saliva during asymptomatic and symptomatic SARS-CoV-2 infection.

N-protein presents early in blood, dried blood and saliva during asymptomatic and symptomatic SARS-CoV-2 infection.
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DOI:
10.1038/s41467-021-22072-9
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发表时间:
2021-03-26
影响因子:
16.6
通讯作者:
Ball AJ
Ball AJ
中科院分区:
综合性期刊1区
文献类型:
--
作者:
Shan D;Johnson JM;Fernandes SC;Suib H;Hwang S;Wuelfing D;Mendes M;Holdridge M;Burke EM;Beauregard K;Zhang Y;Cleary M;Xu S;Yao X;Patel PP;Plavina T;Wilson DH;Chang L;Kaiser KM;Nattermann J;Schmidt SV;Latz E;Hrusovsky K;Mattoon D;Ball AJ

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COVID-19疫情继续对全球社会及经济造成前所未有的影响。目前仍然需要高性能的SARS-CoV-2检测,可以广泛用于感染监测。在这里,我们报告了一种高灵敏度的单分子阵列(Simoa)的免疫分析,用于检测静脉和毛细血管血液和唾液中的SARS-CoV-2核衣壳蛋白(N-蛋白)。在迄今为止进行的研究中的所有基质中,我们观察到在有症状、无症状和症状前PCR+个体中第1-7天与分子检测的>98%阴性百分比一致性和>90%阳性百分比一致性。N-蛋白负荷随着抗SARS-CoV-2加标IgG的增加而减少,并且N-蛋白水平与唾液中以及匹配的唾液和毛细血管血液样品之间的RT-PCR Ct值相关。Simoa SARS-CoV-2 N蛋白检测试剂盒通过测量血液或唾液中的抗原水平,使用非侵入性、不依赖拭子的采集方法,有效检测SARS-CoV-2感染,为在家和护理点样本采集提供了可能性。在这里,作者开发了一种单分子阵列(Simoa)免疫测定法,用于检测静脉和干燥毛细血管血以及唾液中的SARS-CoV-2核衣壳蛋白。该检测试剂盒在有症状、无症状和症状前PCR+个体中表现出良好的性能。
The COVID-19 pandemic continues to have an unprecedented impact on societies and economies worldwide. There remains an ongoing need for high-performance SARS-CoV-2 tests which may be broadly deployed for infection monitoring. Here we report a highly sensitive single molecule array (Simoa) immunoassay in development for detection of SARS-CoV-2 nucleocapsid protein (N-protein) in venous and capillary blood and saliva. In all matrices in the studies conducted to date we observe >98% negative percent agreement and >90% positive percent agreement with molecular testing for days 1–7 in symptomatic, asymptomatic, and pre-symptomatic PCR+ individuals. N-protein load decreases as anti-SARS-CoV-2 spike-IgG increases, and N-protein levels correlate with RT-PCR Ct-values in saliva, and between matched saliva and capillary blood samples. This Simoa SARS-CoV-2 N-protein assay effectively detects SARS-CoV-2 infection via measurement of antigen levels in blood or saliva, using non-invasive, swab-independent collection methods, offering potential for at home and point of care sample collection. Here the authors develop a single molecule array (Simoa) immunoassay for detection of SARS-CoV-2 nucleocapsid protein in venous and dried capillary blood as well as saliva. The assay shows good performance in symptomatic, asymptomatic, and pre-symptomatic PCR+ individuals.
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