Our ultrasensitive immunosensors are based on principles of two fully developed technologies, enzyme-linked immunosorbent assay (ELISA) and self-assembly monolayer (SAM). The principle of ELISA is to bind the targets in samples by using the antibody or antigen (capture) coated inside the microplate and then wash away the nonspecific binding particles. After the washing process, detected antibodies are added to bind on the targets. At the end, add horseradish peroxidase (HRP)-modified secondary antibodies for color change in order to quantitate concentration of testing targets.
Despite the high accuracy of ELISA, it is a complex procedure and usually takes hours to complete. In order to simplify the procedure and shorten the turnaround time from hours to 15 minutes, we have developed antibody modified self-linkable dual-nanozyme that functions as detected antibodies, secondary antibodies and enzyme of oxidation to H2O2 and 3,3’,5,5’-tetramethylbenzidine (TMB) for color change. Furthermore, for the purpose of commercialization, our nanozyme was designed to be more stable than HRP. It can be stored at room temperature for at least 10 months and is not affected by pH value changes in various samples.
On the other hand, to increase the sensitivity and eliminate background signals when compared to ELISA, we chose glass vials to be our containers and fashioned the unique glass fabrication on the surface of the glass by adapting SAM technology. To further verify its scalability, we have conducted glass fabrication procedures in two different production sites with two manufacturing partners to identify issues in production and define check points in the process of manufacturing in order to be qualified in the quality management system and ISO13485 in the future. Above all, we have full control over our key components, including their formulas and production processes. The manufacturers only receive solutions comprising those key components and follow the protocols as designated.