dbGaP Study Accession: phs002729

NIH Institute/Center: NIDA

RADx Data Program: RADx-rad

DOI: 10.60773/md02-q556

Release Date: 11/07/2022

Study Description: Presently, the application of molecular technology such as RT-qPCR and digital PCR (dPCR) to quantify SARS-CoV-2 and related targets in wastewater is cumbersome, time-consuming, and costly. While progress has been made on the development of methods and the interpretation of data, much remains to be improved for the technology to be used as a public health management tool. A major drawback in the current approaches are: 1) the lack of streamlined and consistent pre-analytical processing steps, 2) coverage across the relevant targets requires a high number of reactions (>20) from any single sample to provide quantitative information, and 3) a lack of vision of the development of a pathogen/marker panel, much like those used in clinical arenas, for interpretation of the data across different states, regions and nations. The goal of this project was to successfully navigate these three limitations toward development of an advanced digital array PCR system as part of the development of public health warning system that is not dependent on clinical testing and has the ability to rapidly address novel pathogen thrust in the future.

Updated Date: 01/18/2024

Principal Investigator: Ramsey, J. Michael

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Wastewater Surveillance; Virological Testing

Data Collection Method: Wastewater Sampling

Keywords: Digital Droplet PCR; Digital Array PCR; RNA; DNA; Molecular, Protein

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Environmental (Physical); Genomic; Other

Data Types, Other: Environmental data includes reporting and operations data related to wastewater treatment plants in the context of determining community prevalence of SARS CoV-2, i.e. "flow", "wastewater treatment plant function", "population served", "sewershed dynamics" (e.g. rainfall), and "normalizing factors"; Data is according to wastewater concentration of SARS CoV-2 and related

Study Start Date: 01/01/2021

Study End Date: 05/31/2023

Species: Non-Human Data

Estimated Cohort Size: 20

Study Population Focus: N/A

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35749532/

Acknowledgement Statement: This study was supported through funding, 4U01DA053899-02, for the National Institute on Drug Abuse (NIDA) as part of the RADx-rad program. We acknowledge the support of the CDC and the NC DHHS who are willing to share the WWTP data and publicly related information such as sewershed population served, and for forth. Approved users should acknowledge the provision of data access by dbGaP for accession phs002729.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-20-015

NIH Grant or Contract Number(s): 4U01DA053899-02

Consent/Data Use Limitations: General Research Use