期刊
CLINICAL & TRANSLATIONAL IMMUNOLOGY
卷 10, 期 7, 页码 -出版社
WILEY
DOI: 10.1002/cti2.1312
关键词
COVID-19; IgG; multiplex; SARS-CoV-2; serological assay
类别
资金
- Region Stockholm
- Region Skane
- Knut and Alice Wallenberg Foundation
- Science for Life Laboratory (SciLifeLab)
- Erling Persson family foundation
- Atlas Copco
- EU grant (CoroNab)
A high-throughput multiplex bead-based serological assay was developed and validated, using three selected antigens with high sensitivity and specificity. The best assay performance was achieved with a combination of two antigens, providing a sensitivity of 99.7% and a specificity of 100%.
Objective. The COVID-19 pandemic poses an immense need for accurate, sensitive and high-throughput clinical tests, and serological assays are needed for both overarching epidemiological studies and evaluating vaccines. Here, we present the development and validation of a high-throughput multiplex bead-based serological assay. Methods. More than 100 representations of SARS-CoV-2 proteins were included for initial evaluation, including antigens produced in bacterial and mammalian hosts as well as synthetic peptides. The five best-performing antigens, three representing the spike glycoprotein and two representing the nucleocapsid protein, were further evaluated for detection of IgG antibodies in samples from 331 COVID-19 patients and convalescents, and in 2090 negative controls sampled before 2020. Results. Three antigens were finally selected, represented by a soluble trimeric form and the S1-domain of the spike glycoprotein as well as by the C-terminal domain of the nucleocapsid. The sensitivity for these three antigens individually was found to be 99.7%, 99.1% and 99.7%, and the specificity was found to be 98.1%, 98.7% and 95.7%. The best assay performance was although achieved when utilising two antigens in combination, enabling a sensitivity of up to 99.7% combined with a specificity of 100%. Requiring any two of the three antigens resulted in a sensitivity of 99.7% and a specificity of 99.4%. Conclusion. These observations demonstrate that a serological test based on a combination of several SARS-CoV-2 antigens enables a highly specific and sensitive multiplex serological COVID-19 assay.
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