URL: http://www.cdc.gov/osels/lspppo/Genetic_Testing_Quality_Practices/Nex-StoCT.html
Proper Citation: Nex-StoCT (RRID:SCR_006777)
Description: National workgroup to define platform-independent approaches for establishing technical process elements of a quality management system (QMS) to assure the analytical validity and compliance of next-generation sequencing (NGS) tests with existing regulatory and professional quality standards. The workgroup identified and addressed gaps in quality practices that could compromise the quality of both clinical laboratory services and translational efforts needed to advance the implementation and utility of NGS in clinical settings. The workgroup was composed of experts with knowledge of and experience with NGS and included clinical laboratory directors, clinicians, platform and software developers and informaticians, as well as individuals actively engaged in NGS guideline development from accreditation bodies and professional organizations. Representatives from US government agencies also participated. These guidelines address four topics that are components of quality management in a clinical environment: (i) test validation, (ii) quality control (QC) procedures to assure and maintain accurate test results, (iii) the independent assessment of test performance through proficiency testing (PT) or alternative approaches and (iv) reference materials (RMs). Discussions were limited to the analytic and informatics processes required for accurate variant calling. The workgroup did not address how variants are prioritized, interpreted or reported.
Abbreviations: Nex-StoCT
Synonyms: Next Generation Sequencing: Standardization of Clinical Testing, Nex-StoCT Working Groups, Next Generation Sequencing: Standardization of Clinical Testing Working Groups, Next Generation Sequencing - Standardization of Clinical Testing
Resource Type: narrative resource, standard specification, data or information resource, knowledge environment
Defining Citation: PMID:23138292
Keywords: next-generation sequencing, clinical, testing, test result
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