CTI: Validation and performance of a multiplex serological method for quantitative detection of antibody responses following SARS-CoV-2 infection or vaccine

Background: Severe acute respiratory syndrome coronavirus 2 (novel coronavirus), an enveloped positive-sense RNA virus, was identified as the causative agent of coronavirus disease 2019 (COVID-19) in January 202 The novel coronavirus encodes various structural proteins, including the highly immunogenic spike protein that forms characteristic rod-shaped spikes from its surface, and the nucleocapsid protein that plays a key role in transcription and viral assemb.

Background: Severe acute respiratory syndrome coronavirus 2 (novel coronavirus), an enveloped positive-sense RNA virus, was identified as the causative agent of coronavirus disease 2019 (COVID-19) in January 202 The novel coronavirus encodes various structural proteins, including the highly immunogenic spike protein that forms characteristic rod-shaped spikes from its surface, and the nucleocapsid protein that plays a key role in transcription and viral assemb.

The development and availability of novel coronavirus diagnostics rapidly increased in the months after the outbreak was declared, followed by the development and launch of vaccines and monoclonal antibodies (mabs) against SARSCoV- To facilitate the development of vaccines and therapeutic antibodies and enable large-scale seroepidemiological studies, robust serological assays are requir.

Quantitative multiplex electrochemiluminescence (ECL)-based serological assays enable sensitive, high-throughput, and simultaneous quantification of immunoglobulin G (IgG) levels for multiple antigens and have been shown to be relevant for 2019-nCoV neutralization assa.

Objective: Reliable quantitative serological assays are required to accurately measure antibody levels following vaccination and natural infecti.

meth.

Results: The standard curve showed that the assay can quantify novel coronavirus antibody levels over a wide ran.

Figure 1 The standard curve precision curve of the 11-point dilution series of 2019-nCoV-specific S, RBD and N antibodies was tested 45 tim.

Figure 1 The standard curve precision curve of the 11-point dilution series of 2019-nCoV-specific S, RBD and N antibodies was tested 45 tim.

TableSummary Characteristics of Multiplex Novel Coronavirus ECL Serological Test Validation

 

Figure 2 Analytical specificity (a) and sensitivity (b) of multiplexed SARS-CoV-2 ECL serology tests to measure antibodies against heterologous and homologous antige.

Figure 2 Analytical specificity (a) and sensitivity (b) of multiplexed SARS-CoV-2 ECL serology tests to measure antibodies against heterologous and homologous antige.

Figure2019-nCoV S, RBD and 2019-nCoV in blood donor samples by serostatus cut-off point (dotted line) according to known 2019-nCoV status (a) and the number of PCR-positive samples with S and N seronegative and seropositive (b) One measure of N-antibody distribution failed the operational validity criter.

Figure2019-nCoV S, RBD and 2019-nCoV in blood donor samples by serostatus cut-off point (dotted line) according to known 2019-nCoV status (a) and the number of PCR-positive samples with S and N seronegative and seropositive (b) One measure of N-antibody distribution failed the operational validity criter.

Conclusion: Multiplex 2019-nCoV ECL serological assay is suitable for efficient and reproducible measurement of 2019-nCoV antigen antibodies in human serum, supporting its application in clinical trials and seroepidemiological studi.

Original source: Wilkins D, Aksyuk AA, Ruzin A, et .
Validation and performance of a multiplex serology assay to quantify antibody responses following SARS-CoV-2 infection or vaccinati.
Clin Transl Immunology 2022;11(4) Validation and performance of a multiplex serology assay to quantify antibody responses following SARS-CoV-2 infection or vaccinati.
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