Unmet Need / Invention Novelty To mitigate the spread of infectious diseases, rapid and widely available testing methods are needed to screen immunity at the population scale. Current antibody quantification assays often require lab-based instrumentation and methodology that can only be used/followed by skilled personnel. Unfortunately, at-home tests are not broadly available and are limited in their quantitative detection capabilities. There is thus an unmet need for a point of care diagnostic test for detection and monitoring of infectious disease immunity.
Technical Details: Johns Hopkins researchers developed a glucometer-based immunoassay as a point of care diagnostic for infectious disease antibodies. Researchers created a recombinant fusion protein consisting of an anti-human immunoglobulin G (IgG) symmetrically linked to two enzymes that detects serum antibodies and quantifies their presence through a readout that is detectable by commercial glucometers. Successful proof-of-concept measurements demonstrated detection of anti-SARS-CoV-2 spike protein antibodies in blinded clinical training sets with sensitivity comparable to gold standard commercial ELISA-based detection methods. The results of this study indicate that the immunoassay can deliver accurate readouts of serum antibody levels. This information can be useful in monitoring the spread of and protection against infectious diseases, and can be used to guide public health and vaccination measures.
Value Proposition:
- Quick and quantitative diagnostic immunoassay using a human antibody fusion protein
- Detects serum-circulating antibodies specific to a broad array of antigenic polypeptides
- Applicable diagnostic for infectious and autoimmune diseases and tool for monitoring disease protection (natural or vaccine-induced)
Looking for Partners to: Develop & commercialize a glucometer immunoassay as point of care diagnostic for infectious disease
Stage of Development: Pre-Clinical
Data Availability: Ex-vivo including proof-of-concept with clinical samples from COVID-19 patients
Publication(s): Leonard EK, Pellitero MA, Juelg B, Spangler JB†, Arroyo-Currás N†. Antibody-invertase fusion protein enables quantitiative detection of SARS-CoV-2 antibodies using widely available glucometers. Online ahead of print. J Am Chem Soc. https://pubs.acs.org/doi/full/10.1021/jacs.2c02537
