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.
【저자키워드】 SARS-CoV-2, viral infection, Diagnostic markers, 【초록키워드】 Saliva, SARS-COV-2 infection, COVID-19 pandemic, point of care, Infection, RT-PCR, anti-SARS-CoV-2, nucleocapsid protein, Antigen, Protein, immunoassay, Asymptomatic, pre-symptomatic, symptomatic, Ct-value, Swab, molecular, Blood, Simoa, Non-invasive, Increases, positive, SARS-CoV-2 nucleocapsid, N-protein, SARS-CoV-2 test, capillary blood, capillary blood samples, venous, decrease, observé, detect, develop, conducted, individuals, 【제목키워드】 Blood, symptomatic SARS-CoV-2 infection,