COVID-19 Antibody Testing Research Assays

Responding to the needs of the COVID-19 pandemic requires flexibility, speed, and unparalleled research and industry collaboration. Our commitment to scientific research has never been stronger. 

Our COVID-19 serology research and development (R&D) team at Thermo Fisher Scientific has developed a comprehensive portfolio of research products, available worldwide to help solve the questions most relevant for this pandemic. 

Whether you are working to define COVID-19 immunity, exploring the biology of the vaccine response, understanding seroprevalence, or investigating the connection between COVID-19 and autoimmunity, we have the tools ready to support you.

 

 

 

 

 

The spike protein is a large, heavily glycosylated, trimeric complex of interlinked S1 and S2 subunits1

 

 

 


A flexible portfolio of COVID-19 serology research products

I. Immunity and antibody quantification:

The quantification of antibody responses to SARS-CoV-2 is critical for many research efforts, including understanding COVID-19 immunity. We know that not all individuals mount the same antibody response to SARS-CoV-2.2 Similar to how certain antibody titers correlate with immunity for other viral infections3, it is reasonable to assume that antibody quantification will identify an immunity titer threshold, thus allowing the identification of individuals who are most likely to have immune protection.

A diverse menu of quantitative antibody tests to meet your research needs:

A diverse menu of quantitative antibody tests to meet your research needs:


  • Thermo Scientific™ EliA™ SARS-CoV-2-Sp1 IgG, Thermo Scientific™ EliA™ SARS-CoV-2-Sp1 IgM, and Thermo Scientific™ EliA™ SARS-CoV-2-Sp1 IgA: A three test toolbox* for semi-quantitative detection of IgG, IgM, and IgA recognizing an identical spike S1 antigen, using the fully automated Phadia™ 250 laboratory instrument.
  • Thermo Scientific™ OmniPATH™ 96 Combi SARS-CoV-2 IgG ELISA kit: An open platform enzyme-linked immunosorbent assay (ELISA) for the semi-quantiative detection of SARS-CoV-2 IgG antibodies against the trimeric spike protein in human serum or plasma (including capillary draw). Available in both 96 and 384 well formats.  

 

Understanding immunity requires not only the measurement of antibodies that recognize SARS-CoV-2, but also the understanding of whether the antibodies measured are neutralizing (able to interfere with the virus’ ability to be infectious).4 A primary target of neutralizing antibodies to SARS-CoV-2 is the spike RBD, likely because antibodies that detect this region often have the ability to disrupt the binding of SARS-CoV-2 to the ACE2 receptor, a critical step for virus access into the cell.1, 5-7

In development: A new surrogate neutralization assay

Thermo Scientific™ EliA SARS-CoV-2-Sp1 ACE2 receptor binding inhibition assay (ARBIA): This RUO test detects neutralizing antibodies that inhibit the interaction of the spike S1 protein with the ACE2 receptor, using the fully automated Phadia 250 instrument. This easy-to-use approach can replace the PRNT assay, is suitable for all antibody isotypes and can be beneficial for vaccine development and evaluation, seroprevalence studies, herd immunity assessment research, and determination of protective immunity duration.


II: Semi-Quantitative isotype differentiation and its possible relevance for clinical prognosis and management

There are three predominant antibody isotypes relevant to the body’s reaction to SARS-CoV-2: IgA, IgM, and IgG. Learn more about the role of the isotypes in COVID-19 disease to understand how detecting the individual isotypes can improve the power of serology testing throughout the course of COVID-19 disease and recovery.

The differing characteristics between isotypes means that certain types of antibody tests can have specific use cases. Studying how these isotypes behave is valuable for understanding COVID-19 disease and patients’ vaccine response.

Dynamics of COVID-19 patients’ antibody response

Weeks Past Positive PCR

A total of 463 samples from moderately to severely ill RT-PCR+ patients were collected 0 to 24 weeks after a positive RT-PCR result. Samples were analyzed by EliA SARS-CoV-2-Sp1 IgG, IgM, and IgA [EliA U/ml]. Thermo Scientific; data on file.

 

A solution for isotype differentiation

EliA SARS-CoV-2-Sp1 IgG, EliA SARS-CoV-2-Sp1 IgM, and EliA SARS-CoV-2-Sp1 IgA: A three test toolbox* for semi-quantitative detection of IgG, IgM, and IgA recognizing an identical spike S1 antigen, using the fully automated Phadia 250 laboratory instrument.


III. Seroprevalence

Given the wide range of symptoms observed with COVID-19, serology testing is needed to get a more accurate picture of what proportion of a region has seen COVID-19.4, 8 For patients who are unable to acquire a positive RT-PCR test, either because of sampling errors or because they are too far out from symptom onset, antibody testing can help confirm a COVID-19 diagnosis. Antibody studies will also aid in our understanding of the variation in antibody levels observed among populations, how these levels trend over time, and how they may correlate to potential immunity to SARS-CoV-2.4, 9

A diverse menu of antibody tests to meet your seroprevalence needs:
  • EliA SARS-CoV-2-Sp1 IgG, EliA SARS-CoV-2-Sp1 IgM, and EliA SARS-CoV-2-Sp1 IgA: A three test toolbox* for semi-quantitative detection of IgG, IgM, and IgA recognizing an identical spike S1 antigen, using the fully automated Phadia 250 laboratory instrument.

  • OmniPath COVID-19 Total Antibody ELISA test: A qualitative, open platform ELISA test recognizing total antibodies that recognize the RBD of the spike protein.
  • OmniPATH 96 Combi SARS-CoV-2 IgG ELISA kit: An open platform enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of SARS-CoV-2 IgG antibodies against the trimeric spike protein in human serum or plasma (including capillary draw). Available in both 96 and 384 well formats. 
  • Coronavirus Ig Total Human 11-Plex ProcartaPlex Panel: Total antibody detection of antibodies that recognize the trimeric spike protein, spike S1 subunit, spike protein receptor binding domain (RBD), and nucleocapsid, as well as six anti-coronavirus strains (SARS-CoV-1, MERS, CoV-NL63, CoV-KHU1, CoV-229E, CoV-OC43) in a single well, using Luminex xMAP technology.

  • Human SARS-CoV-2 Spike (Trimer) ELISA kit: A solid-phase sandwich ELISA test designed for semi-quantitative detection of total antibodies that recognize the trimeric spike protein.

IV. Autoantibodies in COVID-19 patients

Emerging evidence suggests that monitoring autoimmune markers may be important for understanding acute and long term COVID-19 immune dysregulation. Autoantibodies have been detected in a significant portion of severe COVID-19 patients, including type I IFN-α2 and IFN-ω, ANAs, anti-cardiolipin, and anti-β2-glycoprotein antibodies.10-12 With over 57 clinically relevant autoimmune diagnostic tests, our EliA portfolio enables you to explore the COVID-19 connection to autoimmunity.

 

* EliA SARS-CoV-2-Sp1 IgM and EliA SARS-CoV-2-Sp1 IgA are RUO only.

References

1.Pillay TS. Gene of the month: the 2019-nCoV/SARS-CoV-2 novel coronavirus spike protein. Journal of clinical pathology. 2020;73(7):366-9.

2.Long QX, et al. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nature medicine. 2020.

3.Krammer F, et al. Serology assays to manage COVID-19. Science (New York, NY). 2020;368(6495):1060-1.

4.Hanson KE, et al. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serological Testing. Infectious Diseases Society of America. 2020.

5.Wan J, et al. Human-IgG-Neutralizing Monoclonal Antibodies Block the SARS-CoV-2 Infection. Cell reports. 2020;32(3):107918.

6.Rogers TF, et al. Isolation of potent SARS-CoV-2 neutralizing antibodies and protection from disease in a small animal model. Science (New York, NY). 2020.

7.Yu F, et al. Receptor-binding domain-specific human neutralizing monoclonal antibodies against SARS-CoV and SARS-CoV-2. Signal transduction and targeted therapy. 2020;5(1):212.

8.Petersen E, et al. Comparing SARS-CoV-2 with SARS-CoV and influenza pandemics. The Lancet Infectious Diseases. 2020;20(9):e238-e44.

9.Lerner AM, et al. The COVID-19 Serology Studies Workshop: Recommendations and Challenges. Immunity. 2020.

10.Bastard P, et al. Autoantibodies against type I IFNs in patients with life-threatening COVID-19. Science (New York, NY). 2020;370(6515).

11.Pascolini S, et al. COVID-19 and immunological dysregulation: can autoantibodies be useful? Clinical and translational science. 2020.

12.Zuo Y, et al. Prothrombotic autoantibodies in serum from patients hospitalized with COVID-19. Science translational medicine. 2020.