dbGaP Study Accession: phs002689

NIH Institute/Center: NHLBI

RADx Data Program: RADx-rad

DOI: 10.60773/bsnf-k280

Release Date: 07/21/2022

Study Description: The pandemic caused by COVID-19 has been associated with a very high disease burden as well as high global financial costs. With this pandemic came massive shut downs of both private and public businesses including schools, retail stores, and restaurants. In order to be able to safely open these places of business and have millions of workers return to work and children return to school safely, there is a dire need for a rapid, simple, and inexpensive test which can be administered in non-clinical settings including businesses, schools, and even at home. There are over 600 tests currently being developed, including potentially promising tests using saliva samples and nasopharyngeal swabs. However, these tests have several disadvantages including requirement of instruments, discomfort with nasopharyngeal swabs, and/or long processing times. A simple, low-cost, rapid saliva-based test was developed using test strips that incorporate novel high affinity SARS-CoV-2 binder nanodiscs. The aims of this study were focused on producing and optimizing the test strip components and performing a feasibility study on archived patient samples. By completing these goals, test strips that have the capability of use in office settings, schools, sports events, and potentially at home were produced. To achieve these goals, a partnership was established between bioActive Labs LLC, led by Dr. Jeff Hall who has more than 25 years of experience in design and development of medical diagnostics, and this study's lab, which has engineered the new binder proteins and developed the SARS-CoV-2 assays.

Updated Date: 12/09/2022

Principal Investigator: Loscalzo, Joseph

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Rapid Diagnostic Test (RDT)

Data Collection Method: Antigen Testing Device

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Other

Data Types, Other: Detection of spike protein using novel antigen binder protein

Study Start Date: 12/21/2020

Study End Date: 08/31/2022

Species: Non-Human Data

Estimated Cohort Size: 60

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 3U01HL146002-04S2, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx-rad program. A special acknowledgment of appreciation to our study team. Approved users should acknowledge the provision of data access by dbGaP for accession phs002689.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-272

NIH Grant or Contract Number(s): 3U01HL146002-04S2

Consent/Data Use Limitations: General Research Use