title: Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.
abstract: Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials.
authors: Division of Preparedness and Emerging Infections, Centers for Disease Control and Prevention, Atlanta, Georgia, USA AGargis@cdc.gov.
authors: Amy S
authors: AS
authors: Gargis
authors: Division of Laboratory Systems, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors: Lisa
authors: L
authors: Kalman
authors: Division of Laboratory Systems, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors: Ira M
authors: IM
authors: Lubin
mesh_terms: D000068:Accreditation; D059014:High-Throughput Nucleotide Sequencing / Q000379:methods*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D059021:Laboratory Proficiency Testing / Q000379:methods*; D017410:Practice Guidelines as Topic; D011634:Public Health; D011785:Quality Assurance, Health Care / Q000379:methods*; D011786:Quality Control