title: Next-generation sequencing workflows in veterinary infection biology: towards validation and quality assurance.
abstract: Recent advancements in DNA sequencing methodologies and sequence data analysis have revolutionised research in many areas of biology and medicine, including veterinary infection biology. New technology is poised to bridge the gap between the research and diagnostic laboratory. This paper defines the potential diagnostic value and purposes of next-generation sequencing (NGS) applications in veterinary infection biology and explores their compatibility with the existing validation principles and methods of the World Organisation for Animal Health. Critical parameters for validation and quality control (quality metrics) are suggested, with reference to established validation and quality assurance guidelines for NGS-based methods of diagnosing human heritable diseases. Although most currently described NGS applications in veterinary infection biology are not primary diagnostic tests that directly result in control measures, this critical reflection on the advantages and remaining challenges of NGS technology should stimulate discussion on its diagnostic value and on the potential to validate NGS methods and monitor their diagnostic performance.
authors.affiliation: Operational Directorate of Viral Diseases, Veterinary and Agrochemical Research Center (CODA-CERVA), Groeselenberg 99, B1180 Ukkel, Belgium
authors.forename: S
authors.initials: S
authors.lastname: Van Borm
authors.affiliation: Australian Animal Health Laboratory, CSIRO, Private Bag 24, Geelong, VIC 3220, Australia
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.affiliation: Swedish University of Agricultural Sciences (SLU), Dept. Biomedical Sciences and Veterinary Public Health, Box 7028, 750 07 Uppsala, Sweden
authors.forename: F
authors.initials: F
authors.lastname: Granberg
authors.affiliation: Australian Animal Health Laboratory, CSIRO, Private Bag 24, Geelong, VIC 3220, Australia
authors.forename: A
authors.initials: A
authors.lastname: Colling
mesh_terms: D000820:Animal Diseases / Q000175:diagnosis* / Q000382:microbiology / Q000821:virology; D000818:Animals; D059014:High-Throughput Nucleotide Sequencing; D021141:Nucleic Acid Amplification Techniques / Q000379:methods* / Q000639:trends; D011786:Quality Control; D015203:Reproducibility of Results; D057188:Workflow
keywords: Validation; Molecular diagnostics; Next-generation sequencing; Quality assurance