Title

Diagnostic Value of Nucleocapsid Protein in Blood for SARS-CoV-2 Infection

UMMS Affiliation

Department of Pathology

Publication Date

2021-12-30

Document Type

Article

Disciplines

Amino Acids, Peptides, and Proteins | Biological Factors | Diagnosis | Immunology and Infectious Disease | Infectious Disease | Microbiology | Virus Diseases

Abstract

BACKGROUND: Biomarkers have been widely explored for coronavirus disease 2019 diagnosis. Both viral RNA or antigens (Ag) in the respiratory system and antibodies (Ab) in blood are used to identify active infection, transmission risk, and immune response but have limitations. This study investigated the diagnostic utility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein (N-Ag) in serum.

METHODS: We retrospectively studied 208 randomly selected cases with SARS-CoV-2 infection confirmed by viral RNA test in swabs. N-Ag concentrations were measured in remnant serum samples, compared to viral RNA or Ab results, and correlated to electronic health records for clinical value evaluation.

RESULTS: Serum N-Ag was detected during active infection as early as day 2 from symptom onset with a diagnostic sensitivity of 81.5%. Within 1 week of symptom onset, the diagnostic sensitivity and specificity reached 90.9% (95% CI, 85.1%-94.6%) and 98.3% (95% CI, 91.1%-99.9%), respectively. Moreover, serum N-Ag concentration closely correlated to disease severity, reflected by highest level of care, medical interventions, chest imaging, and the length of hospital stays. Longitudinal analysis revealed the simultaneous increase of Abs and decline of N-Ag.

CONCLUSIONS: Serum N-Ag is a biomarker for SARS-CoV-2 acute infection with high diagnostic sensitivity and specificity compared to viral RNA in the respiratory system. There is a correlation between serum N-Ag concentrations and disease severity and an inverse relationship of N-Ag and Abs. The diagnostic value of serum N-Ag, as well as technical and practical advantages it could offer, may meet unsatisfied diagnostic and prognostic needs during the pandemic.

Keywords

COVID-19, SARS-CoV-2, biomarker, serum nucleocapsid protein

DOI of Published Version

10.1093/clinchem/hvab148

Source

Zhang Y, Ong CM, Yun C, Mo W, Whitman JD, Lynch KL, Wu AHB. Diagnostic Value of Nucleocapsid Protein in Blood for SARS-CoV-2 Infection. Clin Chem. 2021 Dec 30;68(1):240-248. doi: 10.1093/clinchem/hvab148. PMID: 34358289; PMCID: PMC8436384. Link to article on publisher's site

Journal/Book/Conference Title

Clinical chemistry

Related Resources

Link to Article in PubMed

PubMed ID

34358289

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