A statistically established reference value determined for the Vaxarray Coronavirus (CoV) seroassay to characterize vaccination and natural infection.

Publication date: Nov 15, 2024

Serological diagnostic tests are available that measure antibody levels against SARS-CoV-2 antigens. We utilized the Vaxarray Coronavirus (CoV) seroassay, which measures SARS-CoV-2 IgG antibodies against the full-length spike protein (FLS), receptor binding domain (RBD), and S2 extracellular domain (ECD). Previous serological studies have used reference values that have not been validated and require many samples. Here, we show statistically established reference values determined using the upper tail of the Student t-distribution method. The target population was any personnel age 18 years and older working on a U. S. Navy ship, and vaccinated with Wuhan variant. The relative fluorescence mean (RFM) reference values for the full-length spike protein, RBD, and S2 ECD were 17,731, 13,990 and 9096, respectively. By using generalized non-parametric regression and reference values for the RBD spike protein and S2 ECD of SARS-CoV-2, this study was able to distinguish vaccine-mediated immune responses from natural infections. We provide the method and statistical code as a resource to determine future reference values for other serological assays.

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Concepts Keywords
18years Adolescent
Antibodies Adult
Coronavirus Antibodies, Viral
Student Antibodies, Viral
COVID-19
COVID-19 Serological Testing
COVID-19 Vaccines
COVID-19 Vaccines
Cutoff
Female
Humans
Immunoglobulin G
Immunoglobulin G
Male
Middle Aged
Military Personnel
Nucleocapsid protein
Reference value
Reference Values
SARS-CoV-2
SARS-CoV-2
Spike Glycoprotein, Coronavirus
Spike Glycoprotein, Coronavirus
spike protein, SARS-CoV-2
Student t- distribution
Vaccination
Young Adult

Semantics

Type Source Name
disease MESH infection
disease IDO protein
disease MESH Infectious Diseases
pathway REACTOME Reproduction
disease IDO assay
disease IDO nucleic acid
disease IDO host
disease MESH emergency
drug DRUGBANK Indoleacetic acid
drug DRUGBANK Amino acids
drug DRUGBANK Ademetionine
drug DRUGBANK Immune Globulin Human
drug DRUGBANK Ethanol
drug DRUGBANK Water
drug DRUGBANK Tretamine
drug DRUGBANK Pentaerythritol tetranitrate
disease MESH sid
pathway REACTOME Translation
drug DRUGBANK Methionine
disease MESH COVID 19
disease MESH influenza
disease IDO cell
drug DRUGBANK Etoperidone

Original Article

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