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Salivary SARS-CoV-2 (IgG) Antibody Panel

Biomarkers

Technical Summary

Panel Summary
Optimum Collection Volume: 100 μL
Total Number of Samples Required: 1
Methodology: ECL
Target SARS-CoV-2 Antibodies
SARS-CoV-2 Spike Protein (S1)
SARS-CoV-2 Nucleocapsid Protein (N)
SARS-CoV-2 Receptor Binding Domain (RBD)
Assay Performance*
Sensitivity: 96.5%
Specificity: 98.8%
Predictive Value (at 5% Prevalance)*
PPV: 81%
NPV: 99.8%
*Table Updated: 04.07.21
Biomarkers

How to collect Salivary SARS-CoV-2 (IgG) Antibody Panel

APPROVED SARS-CoV-2 IgG SALIVA COLLECTION METHODS

SARS-CoV-2-Specific Antibody Responses in Saliva

By testing for coronavirus antibodies to a combination of SARS-CoV-2 antigens (Nucleocapsid Protein, Spike Protein, or Receptor Binding Domain in Spike) in the same saliva sample, this test can determine if a subject is:

 

Status of Individual Assay Results
Uninfected N, Spike and RBD negative
Infected naturally N, Spike and RBD positive
Vaccinated N negative, Spike and RBD positive

 

This assay can also effectively track the antibody response to vaccine or natural infection over time and provide relative levels by including a reference standard. Below is representative performance data of an individual sampled by passive drool from the first day of immunization with the Moderna vaccine through a week after receiving their second dose of the vaccine. The lack of N-protein reactivity (shown in green) distinguishes the SARS-CoV-2 vaccination, since the vaccine does not encode N-protein. Here, you can see a moderate increase in Spike Protein/RBD reactivity up to the second immunization (indicated by arrow) and the exponential increase in reactivity post second immunization.

ROC analysis summary

ROC analysis summary for SARS-CoV-2 IgG Antibody Assay, 3-Plex (S-Protein, N-Protein, & RBD) Panel on Passive Drool samples pre-COVID-19 and PCR confirmed positive

N-Protein Spike RBD
Area under the ROC curve
Area 0.994 0.9977 0.9762
Std. Error 0.00396 0.001899 0.01112
95% confidence interval 0.9862 to 1.002 0.9939 to 1.001 0.9544 to 0.9980
P value < 0.0001 < 0.0001 < 0.0001
Data
Controls (Negative N-protein) 84 84 84
Patients (Positive N-protein) 61 61 61

 

 

Note: Salimetrics is currently accepting both serum and saliva research samples for COVID-19 antibody testing. Detection of anti-SARS-CoV-2 IgA and IgM are also available upon request.

References & SARS-CoV-2 (IgG) Antibody Research

  1. Hoepel, et al., (2020). Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses. bioRxiv.
  2. Johnson, et al., (2020). Evaluation of a novel multiplexed assay for determining IgG levels and functional activity to SARS-CoV-2. Clinical Virology.
  3. Grandjean, et al., (2020). Humoral Response Dynamics Following Infection with SARS-CoV-2. medRxiv.
  4. Corbett, et al., (2020). Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. The New England Journal of Medicine.
  5. Folegatti, et al., (2020). Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet.
  6. Pollock, et al., (2021). Correlation of SARS-CoV-2 nucleocapsid antigen and RNA concentrations in nasopharyngeal samples from children and adults using an ultrasensitive and quantitative antigen assay. Journal of Clinical Microbiology.
  7. Majdoubi, et al., (2020). Antibody reactivity to SARS-CoV-2 is common in unexposed adults and infants under 6 months. medRxiv.
  8. Diorio, et al., (2020). Multisystem inflammatory syndrome in children and COVID-19 are distinct presentations of SARS–CoV-2. The Journal of Clinical Investigation.
  9. Huang, et al., (2020). Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet.
  10. Channappanvar R, Perlman S., (2017). Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopatholology.
  11. Li et al., (2020). Coronavirus infections and immune responses. Journal of Medical Virology.
  12. Handbook of Covid-19 Prevention and Treatment.

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