"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."
Serology tests can inform vaccination utilization and status of vaccine response at multiple junctures:
- Data to establish a threshold for protection or immunity
- 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%)
The role of antibody testing within a COVID-19 vaccination program*
A new report from Public Policy Projects (PPP) in the United Kingdom, in partnership with Siemens Healthineers, considers the potential antibody testing holds in increasing the efficiency of the COVID-19 vaccination program, as well as barriers that currently exist. The report recommends public health, NHS personnel, and the industry give consideration to collaborating on new and sustainable diagnostic and monitoring systems post-pandemic.
The report identifies series of key recommendations which include:
- Antibody testing should be regarded as an investigational tool, useful for population surveillance and testing those at risk of a sub-optimal vaccine response.
- Measuring antibody levels post-vaccination to determine eligibility for a booster vaccination has been proposed as a vaccine-sparing targeted strategy. The appropriateness of this approach needs urgent consideration.
- Nations, like the UK, should encourage a global effort, including bodies such as the Centers for Disease Control and Prevention (CDC) and the G7 countries, to work on developing COVID-19 antibody standards as a matter of urgency.
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.
View Press Release