Abstract
A multi-component microarray, applying a novel analysis algorithm, was developed for quantitative evaluation of the SARS-CoV-2 vaccines’ immunogenicity. The array enables simultaneous quantitation of IgG, IgM, and IgA, specific to the SARS-CoV-2 spike, receptor binding domain, and nucleocapsid proteins. The developed methodology is based on calculating an apparent immunoglobulin signal from the linear range of the fluorescent read-outs generated by scanning the microarray slides at different exposure times. A dedicated algorithm, employing a rigorous set of embedded conditions, then generates a normalized signal for each of the unique assays. Qualification of the multi-component array performance (evaluating linearity, extended dynamic-range, specificity, precision, and accuracy) was carried out with an in-house COVID-19, qRT-PCR positive serum, as well as pre-pandemic commercial negative sera. Results were compared to the WHO international standard for anti-SARS-CoV-2 immunoglobulins. Specific IgG, IgM, and IgA signals obtained by this array enabled successful discrimination between SARS-CoV-2 q-RT-PCR positive (seroconverted SARS-CoV-2 patients) and negative (naïve) samples. This array is currently used for evaluation of the humoral response to BriLife, the VSV-based Israeli vaccine during phase I/II clinical trials.
【초록키워드】 COVID-19, SARS-CoV-2, IgG, IgM, Vaccine, immunoglobulins, qRT-PCR, clinical trials, SARS-CoV-2 vaccines, anti-SARS-CoV-2, Receptor binding domain, serum, specificity, Humoral response, Immunoglobulin, Accuracy, IgA, sera, International, Algorithm, Microarray, methodology, Quantitative, SARS-CoV-2 spike, international standard, SARS-CoV-2 patients, Analysis, humoral, linearity, Precision, exposure times, house, array, naïve, Nucleocapsid proteins, fluorescent, quantitation, positive, Specific, q-RT-PCR, Result, carried, assays, generate, linear, seroconverted, unique, the WHO, conditions, normalized, the microarray, the SARS-CoV-2, 【제목키워드】 SARS-CoV-2, novel,