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J Clin Microbiol. 2016 Dec;54(12):2857-2865. Epub 2016 Aug 10.

Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

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Division of Preparedness and Emerging Infections, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Division of Laboratory Systems, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.


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.

[Indexed for MEDLINE]
Free PMC Article

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