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