The Center of Excellence for Serology Development and Emergency Preparedness is dedicated to leading SARS-CoV-2 serology assay development and testing to mitigate the pathogen’s spread and to aid vaccine development in response to pandemic events.  

At the start of the COVID-19 pandemic there was an urgent need to understand how the immune system responds to SARS-CoV-2. The need to delineate the interaction between infection, disease, and immunity is still a major goal for the research community. At the onset of the pandemic, major challenges preventing a scientific rapid response were the lack of relevant available samples and standardized serological assays.

The Center of Excellence for Serology Development and Emergency Preparedness is addressing these issues by building a network of partners and enhancing internal capacity to create standardized methods for sample collection, processing, aliquoting, and serological testing. These samples are used to develop SARS-CoV-2 standards, evaluation and validation assays, and support T-cell and B-cell longitudinal assessments in healthy people and cancer patients.  

Tools for research and vaccine development 

The Center of Excellence for Serology Development and Emergency Preparedness provides well-characterized tools for research and vaccine development. These tools will enable assay development and allow developers to measure anti-SARS-CoV-2 immune responses and compare their results with confidence against other studies and laboratories.  

Rapid response for pandemic control 

The center develops strategies for rapid deployment and expansion of SARS-CoV-2 serological and other immunological testing for public health benefit and pandemic control. 

Collaboration Opportunities

VICD laboratories collaborate with partners across the globe. We have established strong technological capabilities and resources that support pre-clinical and clinical studies in immunology with in-house validated assays that generated a wealth of data in high-impact studies.

We work closely with National Institutes of Health and centers worldwide that are interested in conducting studies from preclinical to clinical trials, in vaccine development, assay development and validations, and critical reagents acquisition. VICD engages with external centers through partnership mechanisms, which are primarily Material Transfer Agreements (MTAs) and Cooperative Research and Development Agreement (CRADA).

To connect or collaborate with VICD, contact Bo Park, Director, Administrative and Finance.

Resources for pandemic preparedness 

The current efforts are concentrated in two areas. The first is building a reference materials bank to enable a rapid response to new outbreaks and the next pandemic, with a focus on SARS-CoV-2. 

The second area is focused on building a longitudinal sample collection to examine anti-viral immune responses from individuals with well-characterized vaccine and infection histories with novel and standard technologies. This area involves collaborations for qualification and validation of assays for investigation of cellular immune responses to SARS-CoV-2 vaccination and infection. 

Data collected will be aggregated into a single data system, the Clinical Data Repository. Samples and linked data will be made available to researchers to advance assay development and vaccine research. 

Our capabilities and specializations

Serology characterization 

We develop, qualify, and validate serology-based assays under Good Clinical Laboratory Practice (GCLP) Standards. 

  • Antibody assays – binding, avidity, and neutralization 

  • Development of new assays and discovery of novel biomarkers 

  • Standards development 

Center of Excellence for biospecimens, acquisition, and characterization  

The Center uses validated assays and processes to create the foundational basis for studies and focuses on building networks of excellence for biospecimen collections, testing, and infrastructure for data and resource management. 

  • Establish partnerships for high-quality, large-volume biospecimen collections 

  • Establish partnerships for biospecimen testing sites  

  • Build data infrastructure and data management systems 

Web portal in development for access to standards, reference materials, and samples 

Well-characterized samples and datasets will be made available to the scientific community. 

  • Serology standards, proficiency, and evaluation panels  

  • Develop proteins and other critical reagents for reference use by the scientific community 

  • Collection of biospecimens (serum, plasma, and PBMC) and associated data  

  • Longitudinal biospecimens collections to understand different markers of immunity to infection and vaccines