"The position statement that you have here is timely. We need to have this discussion and preparation ahead of vaccinating the general population. Serology status is incredibly important due to asymptomatic carriers, and as these vaccines are introduced the need for robust neutralizing antibody testing would become even more important to understand where we are both before and after vaccination."
University of Cambridge (UK), Department of Medicine/CITIID
Serology tests can inform vaccination utilization and status of vaccine response at multiple junctures:
- Data to establish a threshold for protection or immunity
- Determination of appropriate vaccine recipients, especially with limited vaccine availability
- Post-vaccination initial response1
- Duration of vaccination response2
Appropriate characteristics of a serology assay in the assessment of need to vaccinate and vaccine response:
- Quantitative results
- Spike protein receptor-binding domain (S1 RBD) neutralizing IgG antibody detection
- Very high specificity (≥99.5%)
Neutralizing Antibodies: Why the Spike Protein?
SARS-CoV-2 serology assays that utilize the receptor-binding domain (RBD) of the S1 spike antigen detect neutralizing antibodies that block the virus entry into cells.3-8 S1-RBD-specific assays are likely to prove advantageous over S1 and whole spike, especially if using a quantitative assay, as neutralizing versus binding antibodies might be expected to be enriched and therefore better correlate to immunity.
The utilization of the S1-RBD is aligned with the multiple vaccines in development that target or include the SARS-CoV-2 S1 RBD, with the goal of producing neutralizing (and therefore likely protective) antibodies in vaccinated subjects.9 The spike protein and particularly the RBD are the most common target of vaccine designs.
Webinar: SARS-CoV-2 Serology Testing in the Setting of Vaccination
Hear from Dr. Angela Rasmussen, Virologist, on why serology testing is necessary to help inform a long-term vaccination strategy and confirm vaccine effectiveness
Our Collaboration with the CDC & JRC
Siemens Healthineers collaboration with the Centers for Disease Control and Prevention (CDC) and the Joint Research Centre (JRC) of the European Commission will define a threshold for neutralizing antibody, with the goal of determining the level sufficient to confer immunity.
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