SARS-CoV-2 Serology for the Rapid Diagnosis of COVID-19

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "COVID-19 Vaccines and Vaccination".

Deadline for manuscript submissions: closed (31 December 2023) | Viewed by 2248

Special Issue Editor


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Guest Editor
59 MDW Science and Technology, Defense Health Agency, JBSA-Lackland, San Antonio, TX, USA
Interests: virology; filovirus; coronavirus; vaccine development; therapeutic repurposing

Special Issue Information

Dear Colleagues,

Serology tests, or antibody tests, use a variety of techniques to detect antibodies from the blood, revealing whether a person has been exposed to a particular pathogen by looking at their immune response.

Serological tests also vary according to the viral antigens measured. Spike proteins (S) and nucleocapsid proteins (N) are the viral antigens used to detect antibodies for SARS-CoV-2, with the intended use to identify whether an individual was recently or previously infected by the virus. These serology tests can be broadly categorized by their readout platforms used to detect SARS-CoV-2 antibodies: enzyme immunoassay, high-throughput; enzyme immunoassay, medium-throughput; lateral flow assay; and total neutralizing antibodies.

A reliable serology test to rapidly quantify neutralizing antibody levels in a high-throughput manner is essential for diagnosis, vaccine development, and antiviral development—especially once a minimal threshold of nAb has been defined for disease prevention in the near future. Even in a postvaccination era, serology tests will remain critical for studying both individuals’ and the community's protective immunity to safeguard public health around the world. Based on your extensive knowledge and experience, we invite you to contribute with an original report, original observation, or review to highlight the new trends in serology tests for COVID-19.

Dr. Jesus Alberto Silvas
Guest Editor

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Keywords

  • COVID-19
  • SARS-CoV-2
  • serology test
  • antibody test
  • diagnostic test
  • vaccination
  • immunization
  • antibody response

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Published Papers (1 paper)

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Research

21 pages, 1610 KiB  
Article
Validation and Suitability Assessment of Multiplex Mesoscale Discovery Immunogenicity Assay for Establishing Serological Signatures Using Vaccinated, Non-Vaccinated and Breakthrough SARS-CoV-2 Infected Cases
by Sushant Shengule, Shweta Alai, Sachin Bhandare, Sumant Patil, Manish Gautam, Bhushan Mangaonkar, Sumit Gupta, Umesh Shaligram and Sunil Gairola
Vaccines 2024, 12(4), 433; https://doi.org/10.3390/vaccines12040433 - 18 Apr 2024
Cited by 1 | Viewed by 1802
Abstract
Antibody responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are multi-targeted and variable over time. Multiplex quantitative serological assays are needed to provide accurate and robust seropositivity data for the establishment of serological signatures during vaccination and or infection. We describe here [...] Read more.
Antibody responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are multi-targeted and variable over time. Multiplex quantitative serological assays are needed to provide accurate and robust seropositivity data for the establishment of serological signatures during vaccination and or infection. We describe here the validation and evaluation of an electro-chemiluminescence (ECL)-based Mesoscale Discovery assay (MSD) for estimation of total and functional IgG relative to SARS-CoV-2 spike, nucleocapsid and receptor binding (RBD) proteins in human serum samples to establish serological signatures of SARS-CoV-2 natural infection and breakthrough cases. The 9-PLEX assay was validated as per ICH, EMA, and US FDA guidelines using a panel of sera samples, including the NIBSC/WHO reference panel (20/268). The assay demonstrated high specificity and selectivity in inhibition assays, wherein the homologous inhibition was more than 85% and heterologous inhibition was below 10%. The assay also met predetermined acceptance criteria for precision (CV < 20%), accuracy (70–130%) and dilutional linearity. The method’s applicability to serological signatures was demonstrated using sera samples (n = 45) representing vaccinated, infected and breakthrough cases. The method was able to establish distinct serological signatures and thus provide a potential tool for seroprevalence of SARS-CoV-2 during vaccination or infection. Full article
(This article belongs to the Special Issue SARS-CoV-2 Serology for the Rapid Diagnosis of COVID-19)
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