Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA Test

OmniPATH COVID-19 Total Antibody ELISA Test

With the OmniPATH COVID-19 Total Antibody ELISA Test, you can feel confident that you’re monitoring the body’s response to the most biologically relevant antigen for neutralizing antibodies to SARS-CoV-2.1-4

Your Path to Trusted COVID-19 Total Antibody Detection

COVID-19 is a rapidly evolving pandemic—and we’re here to support the diagnostic needs of patients with reliable antibody serology testing. The Thermo Scientific™ OmniPATH™ COVID-19 Total Antibody ELISA Test provides:

  • 100% specificity* to the main target of biologically relevant neutralizing antibodies: the receptor binding domain (RBD) of the S1 subunit of the spike (S) protein.Learn about the science of COVID-19 antibody testing. 
  • 100% sensitivity in as few as 15 days post-symptom onset.*
  • An open-platform approach that allows for a highly scalable and cost-effective means to support testing initiatives.

With the OmniPATH COVID-19 Total Antibody ELISA Test, you can feel confident that you’re monitoring the body’s response to the most biologically relevant antigen for neutralizing antibodies to SARS-CoV-2.1-4

 
*100% specificity and 100% sensitivity in 15 days post-symptom onset demonstrated in the Thermo Fisher Scientific Clinical Agreement Study for Emergency Use Authorization.


OmniPATH COVID-19 Total Antibody ELISA Test

OmniPATH COVID-19 Total Antibody ELISA Test

Method: ELISA

Measurement: Qualitative

Detection: Total Antibody

Instrument: Open ELISA

Protein: S1 (RBD)

Sensitivity: 100*

Specificity: 100* 

 
*100% specificity and 100% sensitivity in 15 days post-symptom onset demonstrated in the Thermo Fisher Scientific Clinical Agreement Study for Emergency Use Authorization.


What’s Inside?

 

  • Positive control (ready to use): Solution containing horse anti-SARS-CoV-2
  • Low positive control (ready to use): Solution containing horse anti-SARS-CoV-2
  • Negative control (ready to use): Proteinaceous solution
  • Chromogenic reagent A (ready to use): Hydrogen peroxide solution (H2O2)
  • Chromogenic reagent B (ready to use): 3, 3’, 5, 5’ – tetramethylbenzidine (TMB) solution
  • Enzyme conjugate (ready to use): Recombinant antigen conjugated to horseradish peroxidase (HRP) in a protein-based buffer
  • Microtiter plate (ready to use): Coated with recombinant SARS-CoV-2 antigen protein
  • Microplate sealers
  • Stop solution (ready to use): Diluted sulfuric acid (H2SO4)
  • Wash buffer concentrate (20x concentrate): With NaCl, Tween, 20

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Test Benefits

 

Open ELISA system

Our total antibody test can run on any open ELISA platform, including the Dynex Agility automated ELISA workstation. Open platform flexibility enables you to run this test at the speed and throughput your lab needs on your existing automated instruments*, minimizing initial costs and time needed to bring the test into your laboratory. You also gain efficiency, due to:

  • No patient sample dilution necessary.
  • One qualitative total result per well, detecting IgA, IgG, and IgM all at once.
  • 88 patient sample results per plate.
  • All-in-one test with all-in-one test kit.
  • Option for manual assay procedure.

 

*On automated instrument platforms, assay performance must be established. Assay performance has not been established for use on other automated instrument platforms.

 

Fast and accurate results

The OmniPATH COVID-19 Total Antibody ELISA test is designed for total antibody detection, thus capturing the body’s production of IgA, IgM, and IgG all in one well.1 By measuring for isotypes produced throughout the entire cycle of infection, from acute to recovered, the test can detect immunological response to SARS-CoV-2 within the first eight days of symptom onset in some patients, reaching 100% sensitivity by 15 days after symptom onset.*

That means providers can begin monitoring patients’ antibody levels earlier in the course of COVID-19 disease. The high sensitivity also comes with 100% specificity*, giving you confidence in the positive results, whether you’re conducting an epidemiological study or trying to detect an adaptive immune response in a patient with a high suspicion of COVID-19.

*100% specificity and 100% sensitivity in 15 days post-symptom onset demonstrated in the Thermo Fisher Scientific Clinical Agreement Study for Emergency Use Authorization.

Why choose total antibody?

  • Combined detection of IgG with other isotypes may improve serology sensitivity early in course of COVID-19.1,5
  • IgA is the most abundant immunoglobulin in mucosal surfaces6 and may play an important role in COVID-19 defense in addition to IgG.7
  • Median peak neutralization activity occurs about a month after symptom onset,8 a time when IgA is likely present and able to provide important neutralizing activity in addition to IgG.5,9
  • Total antibody testing captures the fullest picture of adaptive immune antibody response.

 

Learn about the science of COVID-19 antibody testing.

Optimal specificity with spike-protein diagnostics

There are several types of antibody tests on the market, each designed to identify the immune response to different SARS-CoV-2 viral proteins.

OmniPATH measures antibodies that bind to the spike glycoprotein (S protein)—the major surface protein that SARS-CoV-2 uses to bind to a receptor and invade cells.10 Specifically, it targets the RBD of the S1 subunit of the S protein, which is a major target of neutralizing antibodies.2-4

Targeting the RBD—a unique region with less similarity to other coronaviruses11—helps to eliminate cross reactivity and improve assay specificity. OmniPATH has 100% specificity with no observed cross reactivity to Influenza A/B, HCoV-HKU1, HCoV-OC43, Cytomegalovirus (CMV), and Epstein-Barr Virus (EBV).*

SARS-CoV-2 viral proteins
Spike protein and RBD

More than 115 SARS-CoV-2 vaccine candidates are currently being explored.12 A major target of these vaccine approaches is the S protein, with the goal of eliciting neutralizing antibodies.12 With OmniPATH COVID-19 Total Antibody ELISA testing, you can feel confident that you’re monitoring the body’s response to the most biologically relevant antigen for neutralizing antibodies to SARS-CoV-2.1-4

*Demonstrated in experiments for Emergency Use Authorization.

Safety Data Sheets (SDS)

The Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate (automated method) or high (manual and automated method) complexity tests. The OmniPATH COVID-19 Total Antibody ELISA test has been authorized only for the presence of total 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 diagnostic tests for detection of and/ or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

The Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA Test is CE-IVD.

References
  1. Hanson KE, et al. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serological Testing. IDSA. 2020.
  2. Wan J, et al. Human-IgG-Neutralizing Monoclonal Antibodies Block the SARS-CoV-2 Infection. Cell Rep. 2020;32(3):107918. doi: 10.1016/.  \u2028   j.celrep.2020.107918.
  3. Wu Y, et al. A noncompeting pair of human neutralizing antibodies block COVID-19 virus binding to its receptor ACE2. Science. \u2028   2020;368(6496):1274-8. doi: 10.1126/science.abc2241.
  4. Cao Y, et al. Potent Neutralizing Antibodies against SARS-CoV-2 Identified by High-Throughput Single-Cell Sequencing of Convalescent \u2028    Patients' B Cells. Cell. 2020;182(1):73-84.e16. doi: 10.1016/j.cell.2020.05.025.
  5. Huang Z, et al. Characteristics and roles of SARS-CoV-2 specific antibodies in patients with different severities of COVID-19. Clin Exp \u2028    Immunol. 2020. doi: 10.1111/cei.13500.
  6. Breedveld A, et al. IgA and FcαRI: Pathological Roles and Therapeutic Opportunities. Front Immunol. 2019;10:553. doi: 10.3389/\u2028   fimmu.2019.00553.
  7. Theel ES, et al. The Role of Antibody Testing for SARS-CoV-2: Is There One? Journal of Clinical Microbiology. 2020;58(8):e00797-20. doi: \u2028   10.1128/jcm.00797-20.
  8. Wang K, et al. Longitudinal dynamics of the neutralizing antibody response to SARS-CoV-2 infection. Clin Infect Dis. 2020. doi: 10.1093/cid/\u2028   ciaa1143.
  9. Padoan A, et al. IgA-Ab response to spike glycoprotein of SARS-CoV-2 in patients with COVID-19: A longitudinal study. Clin Chim Acta. \u2028   2020;507:164-6. doi: 10.1016/j.cca.2020.04.026.
  10. Pillay TS. Gene of the month: the 2019-nCoV/SARS-CoV-2 novel coronavirus spike protein. J Clin Pathol. 2020;73(7):366-9. doi: 10.1136/\u2028     jclinpath-2020-206658.
  11. Chia WN, et al. Serological differentiation between COVID-19 and SARS infections. Emerg Microbes Infect. 2020;9(1):1497-505. doi: \u2028     10.1080/22221751.2020.1780951.
  12. Thanh Le T, et al. The COVID-19 vaccine development landscape. Nat Rev Drug Discov. 2020;19(5):305-6. doi: 10.1038/\u2028      d41573-020-00073-5.