dbGaP Study Accession: phs002546

NIH Institute/Center: NIAAA

RADx Data Program: RADx-rad

Release Date: 06/06/2022

DOI: 10.60773/7th6-st50

Updated Date: 04/28/2023

Study Description: The devastation caused by emerging pathogens with fast transmission capacity, such as SARS-CoV-2, has demonstrated the importance of preparedness for future viral outbreaks; this includes the ability for fast deployment of in-situ testing tools and epidemiological surveillance with high temporal and spatial resolution; particularly in places that are most vulnerable to becoming reservoirs of infectious agents. This study involved the development of a versatile multiplexing detection platform for SARS-CoV-2 in saliva. The system integrated signals from different biorecognition elements. Aptamer, antibody, and ACE2 were immobilized onto laser inscribed graphene electrodes, and detection mechanisms targeting SARS-CoV-2 spike protein were studied under varying testing conditions (pH, temperature, ionic strength). After determining the operating conditions for enhanced performance of each biosensor, a self-referencing approach was used between complementary recognition elements (i.e., possible combinations of aptamers, antibodies, and ACE2 enzyme biosensors) to evaluate the effects on accuracy of test results (i.e., risk of false-positive and false-negative results). A saliva pre-treatment protocol was developed to facilitate SARS-CoV-2 testing in human saliva using the multiplex biosensor platform. An open channel microfluidics system was designed to automatically split and channel a single saliva sample into multiple streams to the biosensors without saturation, biofouling, and pump requirement. The development of a functional and reliable multiplex biosensor system is useful for addressing longstanding needs in public health as the respiratory Coronavirus family continues its seasonal visits, which may repeat over several decades, much like the occasional visits from the influenza virus, with varying degrees of virulence.

Principal Investigator: Vanegas-Gamboa, Diana Carolina

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Biosensor Technology

Data Collection Method: Electrochemical Testing Device; Antibody Testing / Other Adaptive Immune Response Test

Study Design: Device Validation Study

Multi-Center Study: TRUE

Study Sites: Clemson University; Iowa State University; University of Hawaii; University of Florida

Data Types: Questionnaires/Surveys; Other; Immunological

Data Types, Other: Biosensor Development

Study Start Date: 12/21/2020

Study End Date: 11/30/2022

Species: Human Data; Non-Human Data

Estimated Cohort Size: 100

Study Population Focus: N/A

Publication URL: https://pubmed.ncbi.nlm.nih.gov/37590297/; https://pubmed.ncbi.nlm.nih.gov/37590297/; https://pubmed.ncbi.nlm.nih.gov/35992634/; https://pubmed.ncbi.nlm.nih.gov/35200361/

Acknowledgement Statement: This study was supported through funding, 4U01AA029328-02, for the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as part of the RADx-rad program. Approved users should acknowledge the provision of data access by dbGaP for accession phs002546.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: RFA-OD-20-014

NIH Grant or Contract Number(s): 4U01AA029328-02

Consent/Data Use Limitations: General Research Use