ABOUT THE lmmuSAFE™ BIOCHIP
lmmuSAFE™ is a novel, lab-based biochip test for COVID-19 that enables highly quantitative determination of both the level and target location of SARS-CoV-2 antibodies in an individual. The tests answer 4 fundamental questions:
Scenario 1 – suspected COVID-19 positive individual
1. Confirming with high accuracy whether an individual has been infected with the virus that causes COVID-19.
2. Determine whether the level and target location of the antibodies in an individual are likely to offer protectivity.
Scenario 2 – following COVID-19 vaccination
3. Confirming that an individual has generated a sufficiently strong immune response to the vaccine to confer protection.
4. Retesting to confirm the status of ongoing protection and evaluating whether a booster vaccine is required.
lmmuSAFE™ utilises Sengenics’ patented KREX™ protein folding technology ensuring that viral antigens are correctly folded, preserving all conformational and linear antibody binding sites. Multiple domains of SARS-CoV-2 Nucleocapsid and Spike proteins including both full-length and numerous truncated versions are used in the tests.
The biochip enables the determination of the target epitopes, titres and immunoglobulin class/sub-class (IgG, IgA, IgM; IgG1-4) of antibodies produced across all stages of COVID-19 infection, from initial exposure, disease development, post-recovery or post-vaccination. lmmuSAFE™ can also enable quantitative assessment of patient response in vaccination trials, including differentiation of whether observed antibody responses are due directly to the vaccine or to prior SARS-CoV-2 exposure.
ImmuSAFE™ can be utilised for vaccine clinical trials or sero-prevalence research studies.
Population antibody profiling for sero-prevalence research
The target epitope of antibodies produced following infection exhibit a significant level of diversity across a population. ImmuSAFE™ provides a more accurate determination of sero-prevalence by targeting multiple domains of SARS-CoV-2 proteins.
Determine the protective quality and quantity of antibodies produced
Some individuals produce antibodies that target locations which are neutralising (protective), whereas others produce non-neutralising antibodies. ImmuSAFE™ can be used to identify individuals who have high titres of potentially neutralising antibodies against SARS-CoV-2.
Enable quantitative assessment of antigen-specific response by individuals in vaccine trials
Investigate SARS-CoV-2 specific immunoreactivity in patients and healthy individuals for vaccine development, safety and efficacy determination in clinical trials.
As shown below, data from ImmuSAFE™ tests enable 3 major conclusions to be inferred:
- There is a wide variation in antibody titres across SARS-CoV-2 infected individuals
- There is a high degree of variation in patient-specific antibody responses to the different domains of SARS-CoV-2 proteins
- Wider coverage of target epitopes leads to increased sensitivity and specificity
Relative IgG titres in convalescent COVID-19 patient and healthy sera against different domains of SARS-CoV-2 nucleocapsid [For illustration purposes only].
The ImmuSAFE™ product range also includes other biochip-based tests that incorporate additional viral antigens. Content can be customised based on individualised requirements for vaccine clinical trials or sero-prevalence research studies.
|39508H||ImmuSAFE™ COVID+ Protein Microarray
Contains multiple SARS-CoV-2 specific domains (Nucleocapsid and Spike proteins) including full-length and numerous truncated versions. Key applications are vaccine clinical trials and sero-prevalence research studies.
|39508V||ImmuSAFE™ Respiratory Virus Protein Microarray
Contains multiple SARS-CoV-2 proteins, Nucleocapsid proteins from 5 other human Coronaviruses (SARS-CoV, MERS-CoV, NL63, HKU1 and 229E) as well as Influenza A and B HA antigen subtypes. Key application is sero-prevalence research studies.
|39508R||ImmuSAFE™ Discovery Virus Protein Microarray
Contains multiple SARS-CoV-2 proteins, Nucleocapsid proteins from 13 other Coronaviruses including 5 human Coronaviruses (SARS-CoV, MERS-CoV, NL63, HKU1 and 229E) as well as Influenza A and B HA antigen subtypes. Key application is for research and development purposes.
All antigens are expressed in sf9 insect cells using the patented KREX functional proteomics technology. Viral antigens are full-length, correctly folded, functional, with both conformational and non-conformational antibody binding sites preserved. Each antigen is supplied as either lysate or purified protein.
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