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

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.

“In clinical practice, my patients who have either had the Covid-19 infection or have been vaccinated have been extremely interested in measuring their antibody response. I explain to them that this is the best surrogate we currently have to predict if they will likely be protected from future infection. Having had the vaccine myself and subsequently testing my own blood, I was immensely relieved to see I had developed anti-spike protein antibodies. It felt like I had put on an anti-Covid-19 Kevlar suit.”
Kevin Latinis, MD, PhD
Latinis Rheumatology, LLC, Kansas City (Harrisonville, MO and Leawood, KS)

"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."
Ankur Mutreja, PhD
University of Cambridge (UK), Department of Medicine/CITIID

“As an immunologist and clinician, I certainly see the value of serology testing in understanding the immune response to vaccines, as outlined in the position paper. With every Covid-19 vaccine targeting the spike protein, it just makes sense that measuring the immune response against spike protein is the focus going forward with serology testing. Further, scientifically I think we’re going to see a quantitative threshold for Covid-19 antibody levels that becomes apparent in which the Covid-19 immune response weakens enough that the risk of infection returns. In this respect, measuring Covid-19 antibodies after a natural infection or after vaccination will determine if someone has reached that protective threshold and remeasuring antibody levels over time will determine the need to reimmunize. In some cases, if people who have had Covid-19 infection or those who have been immunized didn’t produce sufficient antibodies, they may need to be revaccinated sooner rather than later.”
Kevin Latinis, MD, PhD
Latinis Rheumatology, LLC, Kansas City (Harrisonville, MO and Leawood, KS)

“In clinical practice, my patients who have either had the Covid-19 infection or have been vaccinated have been extremely interested in measuring their antibody response. I explain to them that this is the best surrogate we currently have to predict if they will likely be protected from future infection. Having had the vaccine myself and subsequently testing my own blood, I was immensely relieved to see I had developed anti-spike protein antibodies. It felt like I had put on an anti-Covid-19 Kevlar suit.”
Kevin Latinis, MD, PhD
Latinis Rheumatology, LLC, Kansas City (Harrisonville, MO and Leawood, KS)

"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."
Ankur Mutreja, PhD
University of Cambridge (UK), Department of Medicine/CITIID

“As an immunologist and clinician, I certainly see the value of serology testing in understanding the immune response to vaccines, as outlined in the position paper. With every Covid-19 vaccine targeting the spike protein, it just makes sense that measuring the immune response against spike protein is the focus going forward with serology testing. Further, scientifically I think we’re going to see a quantitative threshold for Covid-19 antibody levels that becomes apparent in which the Covid-19 immune response weakens enough that the risk of infection returns. In this respect, measuring Covid-19 antibodies after a natural infection or after vaccination will determine if someone has reached that protective threshold and remeasuring antibody levels over time will determine the need to reimmunize. In some cases, if people who have had Covid-19 infection or those who have been immunized didn’t produce sufficient antibodies, they may need to be revaccinated sooner rather than later.”
Kevin Latinis, MD, PhD
Latinis Rheumatology, LLC, Kansas City (Harrisonville, MO and Leawood, KS)

“In clinical practice, my patients who have either had the Covid-19 infection or have been vaccinated have been extremely interested in measuring their antibody response. I explain to them that this is the best surrogate we currently have to predict if they will likely be protected from future infection. Having had the vaccine myself and subsequently testing my own blood, I was immensely relieved to see I had developed anti-spike protein antibodies. It felt like I had put on an anti-Covid-19 Kevlar suit.”
Kevin Latinis, MD, PhD
Latinis Rheumatology, LLC, Kansas City (Harrisonville, MO and Leawood, KS)

Read more in the Siemens Healthineers position paper (pdf) 0.15 MB

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

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.

Learn about anitbody assays available from Siemens Healthineers

Virologist Angela Rasmussen, PhD, presents webinar on SARS-CoV-2 Serology Testing in the Setting of Vaccination

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

Services & Support Education & Training

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Approximately 3-4 weeks after each dose.

Approximately 3, 6, and 9 months and annually; need to boost

Rodda LB, et al. Functional SARS-CoV-2-specific immune memory persists after mild COVID-19. https://doi.org/10.1101/2020.08.11.20171843. This version posted August 15, 2020.

⁴

Piccoli L, et al. Mapping neutralizing and immunodominant sites on the SARS-CoV-2 spike receptor-binding domain by structure-guided high-resolution serology. Cell. 2020.

https://doi.org/10.1016/j.cell.2020.09.037.

⁵

Premkumar, et al. The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci Immunol. DOI: 10.1126/sciimmunol.abc8413 (2020).

⁶

Wajnberg A, et al. Robust neutralizing antibodies to SARS-CoV-2 infection persist for months. Science. 2020. DOI: 10.1126/science.abd7728.

⁷

Chen X, et al. Disease severity dictates SARS-CoV-2-specific neutralizing antibody responses in COVID-19. Sig Transduct Target Ther. 2020;5:180. https://doi.org/10.1038/s41392-020-00301-9

⁸

Iyer AS, et al. Persistence and decay of human antibody responses to the receptor binding domain of SARS-CoV- 2 spike protein in COVID-19 patients. Science Immunology. 2020 Oct 8;5(52):eabe0367. DOI: 10.1126/sciimmunol.abe0367

⁹

Mulligan, MJ et al. Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: InterimReporthttps://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1.full.pdf