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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AI157776-01
Agency Tracking Number: R44AI157776
Amount: $240,405.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA19-272
Timeline
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-02-03
Award End Date (Contract End Date): 2021-10-31
Small Business Information
5750 BAUM BLVD # 310
Pittsburgh, PA 15206-3793
United States
DUNS: 828862701
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ALBERTO GANDINI
 (832) 641-1900
 agandini@acceldx.com
Business Contact
 ALBERTO GANDINI
Phone: (832) 641-1900
Email: agandini@acceldx.com
Research Institution
N/A
Abstract

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.Narrative
Responding to the COVID-19 emergency, Accel Diagnostics is developing an inexpensive, easy to use, rapid,
and quantitative anti-COVID-19 antibody test, RapidQCT™ - The first fully disposable quantitative blood test,
the size of credit card, which require only one drop of blood from finger prick to quantify the COVID-19
antibody titer (concentration), and help monitoring the spreading of the disease and the individual and herd
immunity.

* Information listed above is at the time of submission. *

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