SARS-CoV-2 Serology Testing in the Setting of Vaccination

Siemens Healthineers Position

To enable an effective vaccination strategy, we advocate for the use of accessible, automated, high-throughput SARS-CoV-2 serology testing to help confirm efficacy and promote public health. Siemens Healthineers formulated a position paper based on input from experts in the infectious disease, immunology and vaccine development fields and the currently available body of literature. 

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%)

Neutralization of the SARS-CoV-2 virus with S1-RBD

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.

Virologist Angela Rasmussen, PhD, presents webinar on 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

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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