Abstract
Serological tests play an essential role in monitoring and combating the COVID-19 pandemic. Recombinant spike protein (S protein), especially the S1 protein, is one of the major reagents used for serological tests. However, the high cost of S protein production and possible cross-reactivity with other human coronaviruses pose unavoidable challenges. By taking advantage of a peptide microarray with full spike protein coverage, we analyzed 2,434 sera from 858 COVID-19 patients, 63 asymptomatic patients and 610 controls collected from multiple clinical centers. Based on the results, we identified several S protein-derived 12-mer peptides that have high diagnostic performance. In particular, for monitoring the IgG response, one peptide (aa 1148–1159 or S2–78) exhibited a sensitivity (95.5%, 95% CI 93.7–96.9%) and specificity (96.7%, 95% CI 94.8–98.0%) comparable to those of the S1 protein for the detection of both symptomatic and asymptomatic COVID-19 cases. Furthermore, the diagnostic performance of the S2–78 (aa 1148–1159) IgG was successfully validated by ELISA in an independent sample cohort. A panel of four peptides, S1–93 (aa 553–564), S1–97 (aa 577–588), S1–101 (aa 601–612) and S1–105 (aa 625–636), that likely will avoid potential cross-reactivity with sera from patients infected by other coronaviruses was constructed. The peptides identified in this study may be applied independently or in combination with the S1 protein for accurate, affordable, and accessible COVID-19 diagnosis.
Highlights
COVID-19, which is caused by SARS-CoV-2,1,2 is a global pandemic.By November 28, 2020, 61,592,095 cases has been diagnosed, with 1,441,936 deaths.[3]
Four independent cohorts of samples were collected and designed To fully evaluate the diagnostic potential of spike-derived peptides, sera from four cohorts of COVID-19 patients and controls from multiple medical centers in China were collected (Table 1). (1) Cohort 1 consisted of 55 sera from convalescent COVID-19 patients and 18 controls.[19] (2) Cohort 2 included 2360 sera from 784 in-hospital COVID-19 patients and 542 sera from a variety of controls
The group of autoimmune disease patients was composed of 72 systemic lupus erythematosus (SLE), 7 rheumatoid arthritis (RA), 9 dermatomyositis (DM), Behcet’s disease (BD), ankylosing spondylitis, and 9 Sjogren syndrome patients
Summary
COVID-19, which is caused by SARS-CoV-2,1,2 is a global pandemic.By November 28, 2020, 61,592,095 cases has been diagnosed, with 1,441,936 deaths (https://coronavirus.jhu.edu/map.html).[3]. COVID-19, which is caused by SARS-CoV-2,1,2 is a global pandemic. COVID-19 with high sensitivity and accuracy, false negative results are commonly observed.[4,5] Immunological/serological tests for monitoring SARS-CoV-2-specific IgG and IgM responses provide important information to improve the accuracy of diagnosis.[4,5] In addition, serological tests are suitable for population screening in high-risk regions or among close contacts of patients as well as for surveillance of pandemic spread and assessment of the infection rate in the general population.[6,7,8] the antibody response has been reported to be associated with disease severity and clinical outcomes.[9,10]
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