Thermo Scientific EliA SARS-CoV-2-Sp1 IgG Test

Your path to semi-quantitative COVID-19 IgG 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™ EliA™ SARS-CoV-2-Sp1 IgG test provides results you can trust*:

  • 100% sensitivity eight days after a positive PCR test in 65 subjects who presented with moderate-to-severe COVID-19 symptoms.
  • 99.7% specificity in 340 ethnically diverse samples from age- and gender-matched pre-pandemic blood donors, including ten pregnant women.
  • No cross-reactivity detected when using the EliA SARS-CoV-2-Sp1 IgG test to test 737 specimens from people with infectious or autoimmune diseases ranging from influenza and HIV to other human coronaviruses.

 
* The Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test has not been reviewed by the FDA. This product is distributed consistent with FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)". Data on file 


EliA SARS-CoV-2-Sp1 IgG Test

EliA SARS-CoV-2-Sp1 IgG Test

Method: FEIA

Measurement: Semi-Quantitative

Detection: IgG

Instrument: Phadia 250

Protein: S1

Sensitivity (95% CI): 100* (CI: 99.5-100)

Specificity (95% CI): 99.7* (CI: 98.4-100)

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Interpretation of Test Results

Negative: <7 U/ml

Equivocal: 7-10 U/ml

Positive: >10 U/ml

 
*>8 days post-RT-PCR+ test


What’s Inside?

 

The EliA SARS-CoV-2-Sp1 IgG test kit includes:

Product Article No. Kit Size Description
Thermo Scientific EliA SARS-CoV-2 Sp1 IgG Test 14-6663-02 4 carriers (16 wells each); sufficient for 64 determinations Fluoroenzymeimmunoassay (FEIA) intended for semiquantitative detection of IgG antibodies to SARS-CoV-2 spike 1 in human serum and plasma
EliA CoV Positive Control C1 250 83-1185-02 6 single-use vials (0.3 mL each); sufficient for 2 determinations per vial Control containing IgG antibodies to SARS-CoV-2 spike 1 protein
Product Article No. Kit Size Description
Thermo Scientific EliA SARS-CoV-2 Sp1 IgG Test 14-6663-02 4 carriers (16 wells each); sufficient for 64 determinations Fluoroenzymeimmunoassay (FEIA) intended for semiquantitative detection of IgG antibodies to SARS-CoV-2 spike 1 in human serum and plasma
EliA CoV Positive Control C1 250 83-1185-02 6 single-use vials (0.3 mL each); sufficient for 2 determinations per vial Control containing IgG antibodies to SARS-CoV-2 spike 1 protein

Ready to place an order?


Seamless integration onto the Phadia 250 laboratory system

 

Our semi-quantitative IgG test runs on the Phadia 250 instrument with benefits including:

  • Full automation, including dilutions.
  • Minimal hands-on system prep time and long walkaway times.
  • On-board reagent storage.
  • Ready-to-use reagents.
  • A shared 28-day stable calibration curve with over 20 other EliA IgG tests, including all tests for Connective Tissue Diseases and EliA CCP.

Semi-quantitative results

Unlike qualitative testing, a semi-quantitative antibody assay can be useful for:

  • Understanding the variation in antibody levels in COVID-19 patients.1
  • Tracking antibody trends in patients over time.1
  • Screening convalescent plasma and understanding potential immunity and vaccine response.2

Fast and accurate results

Results from internal experiments showed that in as few as eight days post-molecular test, the EliA SARS-CoV-2-Sp1 IgG test was able to achieve clinical specificity of 99.7% and clinical sensitivity of 100%.* That means providers can begin monitoring patients’ antibody levels earlier in the course of COVID-19 disease while having confidence in the positive results.

Clinical specificity

A set of 340 ethnically diverse samples from age- and gender-matched pre-pandemic blood donors**, including ten pregnant women, were collected from the Serum Bank at Phadia GmbH in Germany.

Samples Number of samples tested Positive results Negative results Specificity
(95% CI):
99.7% (98.4-100%)
Blood donors 330 1 329  
Pregnant women 10 0 10  
Total 340 1 339  
Samples Number of samples tested Positive results Negative results Specificity
(95% CI):
99.7% (98.4-100%)
Blood donors 330 1 329  
Pregnant women 10 0 10  
Total 340 1 339  

When using the EliA SARS-CoV-2-Sp1 IgG to test 737 specimens from people with infectious or autoimmune diseases, no cross-reactivity was detected.***

Antibody positive sera Number of samples tested Positive results Specificity
Human coronaviruses (OC43, HKU1, 229E, NL63) 20 0 100% (95% CI):
99.5-100% CI
Common respiratory viruses (Influenza A&B, RSV, Adenovirus, Enterovirus, Parainfluenza, Rubella, Influenza – vaccinated) 388 0  
Bacterial infections (Mycoplasma pneumoniae, Haemophilus influenzae, Legionella, Tuberculosis, Bordetella pertussis, Chlamydia pneumoniae) 270 0  
Herpesvirus family (CMV, HSV-1/2, EBV, VZV) 24 0  
Hepatitis viruses (HBV, HCV) 10 0  
Autoimmune-related (Rheumatoid factor, Antinuclear antibodies (ANA)) 10 0  
Other (Hypergammaglobumlinemia, Borrelia burgdorferi, HIV) 15 0  
Total number of specimens 737 0  

* Data on file


 ** The blood donor sera were initially obtained from a blood bank in the US and sampled prior to the first reports of SARS-CoV-2 infections in late 2019; data on file.


 *** Cross-reactivity was determined in accordance with CLSI Document EP07; data on file.

Antibody positive sera Number of samples tested Positive results Specificity
Human coronaviruses (OC43, HKU1, 229E, NL63) 20 0 100% (95% CI):
99.5-100% CI
Common respiratory viruses (Influenza A&B, RSV, Adenovirus, Enterovirus, Parainfluenza, Rubella, Influenza – vaccinated) 388 0  
Bacterial infections (Mycoplasma pneumoniae, Haemophilus influenzae, Legionella, Tuberculosis, Bordetella pertussis, Chlamydia pneumoniae) 270 0  
Herpesvirus family (CMV, HSV-1/2, EBV, VZV) 24 0  
Hepatitis viruses (HBV, HCV) 10 0  
Autoimmune-related (Rheumatoid factor, Antinuclear antibodies (ANA)) 10 0  
Other (Hypergammaglobumlinemia, Borrelia burgdorferi, HIV) 15 0  
Total number of specimens 747 0  

* Data on file


 ** The blood donor sera were initially obtained from a blood bank in the US and sampled prior to the first reports of SARS-CoV-2 infections in late 2019; data on file.


 *** Cross-reactivity was determined in accordance with CLSI Document EP07; data on file.

Why choose an IgG test?


  • Since IgG becomes measurable at around the same time as IgM, IgG tests can detect both recent and past infections.1,3,4
  • IgG is the main antibody isotype most likely implicated in long-term immunity.3
  • In other words, IgG testing measures the antibody isotype likely to be important for natural and vaccine immunity.1,3-5

 

Learn more about the types of antibody test.

Optimal specificity with spike-protein diagnostics

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

The EliA SARS-CoV-2-Sp1 IgG Test 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.6 Specifically, it targets the S1 subunit of the S protein, which includes the receptor binding domain (RBD), a major target of neutralizing antibodies.7-9

Targeting the RBD—a unique region with less similarity to other coronaviruses10—helps to eliminate cross reactivity and improve assay specificity. 

SARS-CoV-2 viral proteins
Spike protein and RBD

More than 115 SARS-CoV-2 vaccine candidates are currently being explored. A major target of these vaccine approaches is the S protein, with the goal of eliciting neutralizing antibodies.11 With EliA SARS-CoV-2-Sp1 IgG 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-2.1,7-9

Spike protein and RBD

The Thermo Scientific EliA SARS-CoV-2-Sp1 IgG 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 Thermo Scientific EliA SARS-CoV-2-Sp1 IgG  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. 

References
  • Hanson KE, et al. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serological Testing. IDSA. 2020.
  • Lerner AM, et al. The COVID-19 Serology Studies Workshop: Recommendations and Challenges. Immunity. 2020. Epub 2020/07/02. doi: 10.1016/j.immuni.2020.06.012.
  • Bohn, M., et al. Molecular, serological, and biochemical diagnosis and monitoring of COVID-19: IFCC taskforce evaluation of the latest evidence. Clin Chem Lab Med. 2020; https://doi.org/10.1515/cclm-2020-0722 
  • Sethuraman, N. et al., Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020;323(22):2249-2251. doi:10.1001/jama.2020.8259
  • Theel, E. S., et al. The Role of Antibody Testing for SARS-CoV-2: Is There One? Journal of Clinical Microbiology. 2020;58(8): e00797-00720.
  • 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/jclinpath-2020-206658.

  • Wan J, et al. Human-IgG-Neutralizing Monoclonal Antibodies Block the SARS-CoV-2 Infection. Cell Rep. 2020;32(3):107918. doi: 10.1016/j.celrep.2020.107918.

  • Wu Y, et al. A noncompeting pair of human neutralizing antibodies block COVID-19 virus binding to its receptor ACE2. Science. 2020;368(6496):1274-8. doi: 10.1126/science.abc2241.

  • Cao Y, et al. Potent Neutralizing Antibodies against SARS-CoV-2 Identified by High-Throughput Single-Cell Sequencing of Convalescent Patients' B Cells. Cell. 2020;182(1):73-84.e16. doi: 10.1016/j.cell.2020.05.025.

  • Chia WN, et al. Serological differentiation between COVID-19 and SARS infections. Emerg Microbes Infect. 2020;9(1):1497-505. doi: 10.1080/22221751.2020.1780951.

  • Thanh Le T, et al. The COVID-19 vaccine development landscape. Nat Rev Drug Discov. 2020;19(5):305-6. doi: 10.1038/d41573-020-00073-5.