Standardized Data Quality Acceptance Criteria for a Rapid E. Coli Qpcr Method (Draft Method C) for Water Quality Monitoring at Recreational Beaches

Mano Sivaganesan, U.S. Environmental Protection Agency, National Risk Management Research Laboratory
Tiong Gim Aw, Tulane UniversityFollow
Shannon Briggs, Water Resources Division, Michigan Department of Environmental QualityFollow
Erin Dreelin, Michigan State UniversityFollow
Asli Aslan, Georgia Southern University, Jiann-Ping Hsu College of Public HealthFollow
Samuel Dorevitch, University of Illinois at ChicagoFollow
Abhilasha Shrestha, University of Illinois at ChicagoFollow
Natasha Isaccs, U.S. Geological Survey, Upper Midwest Water Science CenterFollow
Julie Kinzelman, City of Racine Public Health DepartmentFollow
Greg Kleinheinz, University of Wisconsin-OshkoshFollow
Rachel Noble, University of North Carolina at Chapel HillFollow
Rick Rediske, Annis Water Resources Institute, Lake Michigan CenterFollow
Brian Scull, Annis Water Resources Institute, Lake Michigan Center
Susan Rosenberg, Oakland County Health Division LaboratoryFollow
Barbara Weberman, Oakland County Health Division Laboratory
Tami Sivy, Saginaw Valley State University
Ben Southwell, Lake Superior State University
Shawn Siefring, U.S. Environmental Protection Agency, Office of Research and Development, National Exposure Research Laboratory
Kevin Oshima, U.S. Environmental Protection Agency, Office of Research and Development, National Exposure Research LaboratoryFollow
Richard Haugland, U.S. Environmental Protection Agency, Office of Research and Development, National Exposure Research LaboratoryFollow

Document Type

Article

Publication Date

3-15-2019

Publication Title

Water Research

DOI

10.1016/j.watres.2019.03.011

ISSN

0043-1354

Abstract

There is growing interest in the application of rapid quantitative polymerase chain reaction (qPCR) and other PCR-based methods for recreational water quality monitoring and management programs. This interest has strengthened given the publication of U.S. Environmental Protection Agency (EPA)-validated qPCR methods for enterococci fecal indicator bacteria (FIB) and has extended to similar methods for Escherichia coli (E. coli) FIB. Implementation of qPCR-based methods in monitoring programs can be facilitated by confidence in the quality of the data produced by these methods. Data quality can be determined through the establishment of a series of specifications that should reflect good laboratory practice. Ideally, these specifications will also account for the typical variability of data coming from multiple users of the method. This study developed proposed standardized data quality acceptance criteria that were established for important calibration model parameters and/or controls from a new qPCR method for E. coli (EPA Draft Method C) based upon data that was generated by 21 laboratories. Each laboratory followed a standardized protocol utilizing the same prescribed reagents and reference and control materials. After removal of outliers, statistical modeling based on a hierarchical Bayesian method was used to establish metrics for assay standard curve slope, intercept and lower limit of quantification that included between-laboratory, replicate testing within laboratory, and random error variability. A nested analysis of variance (ANOVA) was used to establish metrics for calibrator/positive control, negative control, and replicate sample analysis data. These data acceptance criteria should help those who may evaluate the technical quality of future findings from the method, as well as those who might use the method in the future. Furthermore, these benchmarks and the approaches described for determining them may be helpful to method users seeking to establish comparable laboratory-specific criteria if changes in the reference and/or control materials must be made.

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Copyright belongs to Elsevier. Information regarding the dissemination and usage of journal articles can be accessed through the following links.

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