A novel approach is required to overcome inherent technical problems in existing assays to enhance specificity and sensitivity.
Principles of Universal EpitoGen® COVID-19 test
- Appreciation of the B-cell immunodominance phenomenon. This will enrich for the positive signal and improve sensitivity. Another advantage is that cross-reactive epitopes, especially those with homology with seasonal coronaviruses, can be eliminated, subsequently improving specificity.
- A platform to overcome population heterogeneity (i.e. HLA genetic variation, co-morbidities, age, ethnicity, etc).
- Universal EpitoGen is Differential EpitoGen amenable to combining multiple SARS-CoV-2 proteins (5 antigens) in one test, subsequently improving sensitivity of the assay.
- Universal EpitoGen overcomes SARS-CoV-2 genetic variability (i.e. mutations) by inclusion of prevalent mutations.
Using EpitoGen Technology, a set of 15 immunodominant epitopes, along with their corresponding major circulating mutants (45 prevalent mutations), from five (N, S, M, ORF3a and ORF7a) SARS-CoV-2 proteins were complexed to create a universal antigen. The mutations are present in the UK, South African, Brazilian and Indian variants.
Intended Use of EpitoGen® Universal
Detection of antibody response to SARS-CoV-2 resulting from vaccination and/or infection