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Role of Serology Tests in COVID-19

Antibody Testing Is Critical in Overcoming the COVID-19 Pandemic—Now and in the Future

Why Antibody Tests?

Antibody tests play an important role throughout the patient care pathway and are vital for the management and surveillance of the virus. They are critical in determining the full scope of the disease, combating the pandemic, and rebuilding public confidence. 

Highly accurate antibody tests help inform clinical and public health decisions as we look towards safely opening our communities. Antibody tests can be used for the following:

  • As an adjunct to PCR tests to aid in clinical assessment1,2
  • To help determine prior exposure to the virus, by detecting antibodies that may neutralize the virus3,4
  • To identify potential donors of convalescent plasma3-5
  • For epidemiological purposes including establishing prevalence of disease in populations
  • May help verify effectiveness of vaccines as they become available3,4 
     

Specificity in COVID-19 testing
For SARS-CoV-2 antibody testing, the CDC suggests use of tests with a specificity ≥99.5% to minimize the potential for false-positive results.2

There are numerous tests that claim to detect antibodies to the SARS-CoV-2 virus; only a few are highly accurate:

Specificity Matters

Which antibody tests?

When an individual is infected with the SARS-CoV-2 virus, unique antibodies will develop at different stages of the infection.

SARS-CoV-2 Total antibody tests detect both antibodies (IgM and IgG) that are present during current infection or early during the immune response. SARS-CoV-2 IgG antibody tests specifically detect IgG antibodies that persist and are the basis for an individual’s longer-term immune response.

Testing is key

Estimated time intervals and rates of viral detection are based on data from several published reports. Because of variability in values among studies, estimated time intervals should be considered approximations and the probability of detection of SARS-CoV-2 infection is presented qualitatively.

A robust portfolio of reliable antibody tests to detect neutralizing antibodies

We offer the SARS-CoV-2 IgG (sCOVG) assay*†§ and the SARS-CoV-2 Total assay*‡§ for the qualitative and quantitative detection of neutralizing antibodies to the SARS-CoV-2 virus. This allows clinicians to be able to assess and track patients’ neutralizing antibody levels. The detection of neutralizing antibodies is critical for potential convalescent donor identification as well as determining vaccine efficacy and monitoring post vaccination antibody titers in the future. 

Comparison of numerical results will help determine how the immune response develops in an individual and persists over time. The combination of these assays provides a more complete picture of a patient’s serological status for the most accurate results throughout his or her continuum of care.

Neutralizing Antibodies: Why the Spike Protein?

We smartly selected the receptor-binding domain (RBD) of the S1 spike antigen to detect antibodies that block the virus entry into the cells. This selection is aligned with the multiple vaccines that target or include the SARS-CoV-2 S1 RBD, with the goal of producing protective antibody.

The Siemens Healthineers SARS-CoV-2 antibody assays detect antibodies to the S1 RBD antigen. S1 RBD antibodies are relevant to vaccines incorporating this immunodominant region with the goal to elicit neutralizing (and therefore likely protective) antibodies in vaccinated subjects.6 The spike protein and particularly the RBD are the most common target of vaccine designs.**

GALLERY: Infographics to learn about COVID-19 Testing

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COVID-19 Testing Infographic 2020

Testing is key to reopening communities, businesses, and the economy

Combined testing to detect the virus and antibodies that may protect against it is essential to safely return employees to work.
COVID-19 Testing Infographic 2020
Total Assay Infographic lab version
Total Assay Infographic media version
COVID-19 infographic
CytokineStorm Infographic
Specificty Matters Infographic
Lab testing and frequent laboratory abnormalities in patients with COVID-19 infographic
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* This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting he presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to varying regulatory requirements.

† Claims for detection of neutralizing antibodies and correlation to neutralizing antibody tests have not been reviewed by the FDA and are not available in the U.S. Availability of these claims varies from country to country and is subject to varying regulatory requirements.

‡ Claims for detection of neutralizing antibodies and correlation to neutralizing antibody tests are under development and are not available for use.

§ Assays are for semi-quantitative use in the U.S. 

** The performance of Siemens Healthineers SARS-CoV-2 antibody tests has not been established in vaccinated subjects. Claims for measuring the immune response post-vaccination are under development and are not available for use.

References:

1
https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf Accessed July, 27, 2020
2
https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html Accessed July 27, 2020
3
Bao L, Deng W, Gao H, et al. Reinfection could not occur in SARS-CoV-2 infected rhesus macaques. Posted 2020 May 1. https://doi.org/10.1101/2020.03.13.990226
4
Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody. Pinto, D. et al. Nature https://doi.org/10.1038/s41586-020-2349-y (2020)
5
https://www.ama-assn.org/delivering-care/public-health/sars-cov-2-serology-tests-3-big-limitations-doctors-must-understand Accessed June 11, 2020
6
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: Interim Report https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1.full.pdf