SBIR/STTR Award attributes
Project Summary/Abstract:Millions have developed COVID-19 antibodies through infection or vaccines, and this number will continue to increase. However, antibodies (via infection or vaccines) decay rapidly and vary among individuals. Previous studies have shown decreased protection efficacy because of reduced antibody levels, which, in combination with muted strains, has led to recent wide spread of Delta variant (and other variants) worldwide. A third dose of vaccine is now recommended by the CDC. Regular monitoring of COVID-19 neutralizing antibodies can identify individuals requiring booster vaccines, inform incidence studies, and guide policies regarding vaccination frequency for the population. Although lateral flow assays can potentially be used for rapid COVID- 19 neutralizing antibody tests, they do not provide an accurate level of neutralizing antibodies and has large variations, making them a poor tool to track and predict susceptibility to future infections. More accurate antibody tests done at centralized labs take 2-3 days to turnaround and have a high cost ($150).OptoBio has developed a general purpose microfluidic 96-well ELISA plate (MicroFluere®) technology that reduces assay time 5-10 fold, reduces sample and reagent consumption 5-6 fold, and increases dynamic range by up to 10 fold as compared to traditional 96-well ELISA plate. The goal of Phase I study is to demonstrate the feasibility of leveraging MicroFluere® to develop an inexpensive (lt $10), rapid (20 min), and high throughput (240 tests/hour) assay for COVID-19 neutralizing antibodies of different variants. Currently no product exists that is able to quantify neutralizing antibody at a high throughput and low cost at point-of-care for mass screening. There are two specific aims in Phase 1.Aim #1. Design, test, and optimize neutralizing antibody assays for 6 types of COVID-19 strains. We will first select internal standards for all 6 types of SARS-CoV-2 variants. Then we will optimize the assay parameters such as the plate surface coating, sample dilution factors, and incubation time. Finally, we will evaluate the assay performance such as recovery rate and plate-to-plate repeatability.Aim #2. Validate applicability with human blood samples and benchmark. The assay developed in Aim #1 will be tested at a BSL-2 lab at OptoBio using 75 human serum samples purchased commercially. Five other virus infections will also be included for cross-reactivity evaluation. All the results will be compared with those obtained with SARS-CoV-2 neutralizing antibody kits commercially available.In Phase II, OptoBio will test more samples and add more variants, complete a high throughput automated system, develop pre-coated MicroFluere® plates with adequate shelf lifetime, and develop assays using more convenient matrices such as finger-prick whole blood. Our envisioned product will address the unmet need for rapid, accurate, and low cost COVID-19 antibody detection at clinical labs and point-of-care testing sites. The same product and technology can also be adapted for other viral pandemics that may occur.
