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• W2892618871 abstract "The use of next-generation sequencing (NGS) has expanded from biomedical research settings to clinical laboratories where test results are used to inform medical decision making. Some international, national, local, and professional standards require the validation of clinical tests prior to patient testing. Test validation establishes and documents the analytic performance specifications that describe attributes such as accuracy, precision, analytical sensitivity, and analytical specificity, among other characteristics. The validation process also establishes the cutoffs and other criteria that must be met by the quality control (QC) procedures used during patient testing. Although general criteria for clinical test validation have been well described in regulatory requirements and professional standards, their application to NGS has been challenging because of the unique nature of this technology. For example, the output from a typical NGS sequencing platform during a clinical analysis is thousands or millions of short sequence reads that must be aligned to a reference sequence and further analyzed to generate a reportable result. Metrics unique to NGS are used to describe the quality of these processes. Relating the quality metrics to accepted definitions of the analytic performance characteristics has been challenging. The capacity to validate a clinical test requires the development and use of reference materials to evaluate assay performance over large regions of the human genome, which represents a new paradigm. This chapter discusses the challenges and approaches to meeting regulatory and professional standards for test validation relevant to NGS and the development of QC procedures." @default.
• W2892618871 created "2018-10-05" @default.
• W2892618871 creator A5008018734 @default.
• W2892618871 creator A5042146839 @default.
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• W2892618871 date "2015-01-01" @default.
• W2892618871 modified "2023-10-17" @default.
• W2892618871 title "Assay Validation**Disclaimer: The findings and conclusions in this chapter are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention/The Agency for Toxic Substances and Disease Registry." @default.
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• W2892618871 doi "https://doi.org/10.1016/b978-0-12-404748-8.00021-6" @default.
• W2892618871 hasPublicationYear "2015" @default.
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