A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer.

Summary In response to the COVID-19 pandemic and the increasing need of serological testing we propose the development and clinical validation of a novel serological blood test, RapidQCT™, to aid in the diagnosis and management of the COVID-19 pandemic. As the case for other viral infections, the immune system responds to the COVID-19 infection by developing antibodies (IgG and IgM, among others) against the virus (SARS-COV-2). Antibody titer tests have been a valuable tool to determined individual immunity to several infection diseases, from rubella, to measles. More importantly, as COVID-19 vaccines become available, and a large-scale vaccination strategy will take place, the RapidQCT will help stratify potentially hundred of millions of people and identify who is most likely to benefit, and sparing those who will not. Because the test can be self-administered by patients, it will also promote mobile health management of the pandemic, expanding the breadth of testing, and protecting health care workers from exposure. Current serological tests are binary test, which only provide a yes/no answer, and therefore unable to provide a full picture of the development the immunity across the population. On the other hand, the RapidQCT is an easy to use and rapid test and the first quantitative Point-of-Care (POC) anti-COVID-19 antibody titer test. The size of credit card, it requires only one drop of blood from finger prick to asses the presence and titer level of anti- COVID-19 antibodies. The test companion mobile app enables the tracking of the disease spreading, progression, as well as development of the immunity throughout the population. This project will be completed in two Phases: Phase I - Aim 1: Fabrication Streamline, Scale-Up, and Assay Calibration. In this Aim, we will translate from the current lean development phase to the manufacturing phase. Phase I - Aim 2: Assay Calibration: Here we will determined the assay titer curve calibration. Phase II - Aim 1: Longitudinal monitoring of COVID-19 specific antibody titers. The RapidQCT tests will use to follow longitudinally to three groups: Symptomatic Infected (SI), Asymptomatic Infected (AI), and Not Infected (NI) (control). The trend of the antibody titer for each group will be stratified by gender, age, pre-conditions, and severity of infection. Phase II - Aim 2: Longitudinal monitoring of antibody titers in pregnancy. Immunological changes occurring in COVID-19 positive pregnancy versus the non-pregnant population will be monitored. This project is the result of an ongoing collaboration between Accel Diagnostics and The University of Texas Health Science Center at Houston (Houston, TX), and it is expected to deliver a clinically validated and novel tool to manage the COVID-19 pandemic.