SARS-CoV-2 wastewater variant surveillance: pandemic response leveraging FDA’s GenomeTrakr network

Author:

Timme Ruth E.1ORCID,Woods Jacquelina2,Jones Jessica L.2ORCID,Calci Kevin R.2,Rodriguez Rachel2,Barnes Candace2,Leard Elizabeth2ORCID,Craven Mark3,Chen Haifeng3,Boerner Cameron3,Grim Christopher1ORCID,Windsor Amanda M.1,Ramachandran Padmini1ORCID,Muruvanda Tim4,Rand Hugh4,Tesfaldet Bereket4,Amirzadegan Jasmine5,Kayikcioglu Tunc6,Walsky Tamara5ORCID,Allard Marc1ORCID,Balkey Maria1,Bias C. Hope5ORCID,Brown Eric1,Judy Kathryn1,Pfefer Tina1ORCID,Tallent Sandra M.1ORCID,Hoffmann Maria1, ,Pettengill James4,Jacox Ward7,Engelthaler Dave7,Valentine Michael7,Hepp Crystal7,Kiang David8,Li Zhirong8,Gentry Ryan9,Hagerman Mary Ann9,Robinson Mary9,Knibbs Jesse9,Asbell Madi9,Johnson Beth10,Burns Logan10,Aurand-Cravens Ashley10,Stacy Joshua10,Stiles Tracy11,Fortes Esther11,Doucette Matthew11,Sabina Brandon11,Gagne Luc11,Binns Kelly11,Pandori Mark12,Gorzalski Andrew12,Massic Lauryn12,Dasgupta Sarmila13,Patil Amar13,Panyi Apryle13,Acheampong Edward14,Kirn Thomas14,Palmateer Nicholas14,Fedio Willis15,Preciado Yatziri15,Paladugu Srikanth16,Thakur Siddhartha17,Harden-Plumley Lyndy17,Raymond Luke17,Prarat Melanie18,Sawyer Ashley18,Perkins Jonah18,Dudley Edward19,Kovac Jasna19,M’ikanatha Nkuchia M.19,Nawrocki Erin M.19,Fu Yezhi19,Mbogo Nyduta19,Carpenter-Azevedo Kristin20,Huard Richard C.20,Sierra-Patev Sean20,Davis Megan21,Lane Laura M.21,Jeffcoat Christy A.21,Goodwin Gregory21,Godfrey Gabrielle21,Smith Andrew21,Aroh Chukwuemika N.21,Gilmore Kirsti R.21,Freeman Jessica21,Scaria Joy22,Hennings Jane22,Nelson Eric22,Sun Yan23,Oh Bonnie23,Jost Michael23,Brooks Bryan24,Langan Laura24,Turner Lauren25,Cruz Stephanie Dela25,Maitland Jessica25,Bennett Shelby25,Fink Logan25,Toothman Mary25,Moon Hyunsook25,Liu Yong26,Hendrickson Mychal26,Lucas Darren27,Dykema Phillip27,Meek Roxanne27,Melly Geoff27,Sickles Paige27,McArdle Breanna27,Jansen Anneke27,Young Megan28,Arbaugh Josh28,Kuhl Zachary28,King Ewa29

Affiliation:

1. Office of Regulatory Science, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland, USA

2. Gulf Coast Seafood Laboratory, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Dauphin Island, Alabama, USA

3. Office of Applied Research and Safety Assessment, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Laurel, Maryland, USA

4. Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland, USA

5. Oak Ridge Institute for Science and Education, U.S. Department of Energy, Oak Ridge, Tennessee, USA

6. Joint Institute for Food Safety and Applied Nutrition, University of Maryland, College Park, Maryland, USA

7. Arizona State Department of Health Services and TGen North, Phoenix, Arizona, USA

8. California Department of Public Health, Richmond, California, USA

9. Indiana Department of Health, Indianapolis, Indiana, USA

10. Kentucky State Cabinet for Health and Family Services, Frankfort, Kentucky, USA

11. Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA

12. Nevada State Public Health Laboratory, Reno, Nevada, USA

13. Animal Health Diagnostic Laboratory, New Jersey Department of Agriculture, Ewing, New Jersey, USA

14. New Jersey State Department of Health, Ewing, New Jersey, USA

15. New Mexico State University-Las Cruces, Las Cruces, New Mexico, USA

16. New Mexico Department of Health, Albuquerque, New Mexico, USA

17. College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA

18. Animal Diseases Diagnostic Laboratory (ADDL), Ohio Department of Agriculture, Reynoldsburg, Ohio, USA

19. The Pennsylvania State University, University Park, Pennsylvania, USA

20. State Health Laboratory, Rhode Island Department of Health, Providence, Rhode Island, USA

21. South Carolina Department of Health and Environmental Control, Columbia, South Carolina, USA

22. Department of Veterinary & Biomedical Sciences, South Dakota State University, Brookings, South Dakota, USA

23. Texas Department of State Health Services, Austin, Texas, USA

24. Baylor University, Waco, Texas, USA

25. Virginia Division of Consolidated Laboratory Services, Richmond, Virginia, USA

26. Washington State Department of Agriculture, Olympia, Washington, USA

27. Washington State Department of Health, Shoreline, Washington, USA

28. West Virginia Department of Agriculture, Charleston, West Virginia, USA

29. Association of Public Health Laboratories, Bethesda, Maryland, USA

Abstract

ABSTRACT Wastewater surveillance has emerged as a crucial public health tool for population-level pathogen surveillance. Supported by funding from the American Rescue Plan Act of 2021, the FDA‘s genomic epidemiology program, GenomeTrakr, was leveraged to sequence SARS-CoV-2 from wastewater sites across the United States. This initiative required the evaluation, optimization, development, and publication of new methods and analytical tools spanning sample collection through variant analyses. Version-controlled protocols for each step of the process were developed and published on protocols.io. A custom data analysis tool and a publicly accessible dashboard were built to facilitate real-time visualization of the collected data, focusing on the relative abundance of SARS-CoV-2 variants and sub-lineages across different samples and sites throughout the project. From September 2021 through June 2023, a total of 3,389 wastewater samples were collected, with 2,517 undergoing sequencing and submission to NCBI under the umbrella BioProject, PRJNA757291 . Sequence data were released with explicit quality control (QC) tags on all sequence records, communicating our confidence in the quality of data. Variant analysis revealed wide circulation of Delta in the fall of 2021 and captured the sweep of Omicron and subsequent diversification of this lineage through the end of the sampling period. This project successfully achieved two important goals for the FDA’s GenomeTrakr program: first, contributing timely genomic data for the SARS-CoV-2 pandemic response, and second, establishing both capacity and best practices for culture-independent, population-level environmental surveillance for other pathogens of interest to the FDA. IMPORTANCE This paper serves two primary objectives. First, it summarizes the genomic and contextual data collected during a Covid-19 pandemic response project, which utilized the FDA’s laboratory network, traditionally employed for sequencing foodborne pathogens, for sequencing SARS-CoV-2 from wastewater samples. Second, it outlines best practices for gathering and organizing population-level next generation sequencing (NGS) data collected for culture-free, surveillance of pathogens sourced from environmental samples.

Funder

American Rescue Plan Act of 2021

Publisher

American Society for Microbiology

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