Design and Analytical Validation of Clinical DNA Sequencing Assays

作者: Genevieve Pont-Kingdon , Friederike Gedge , Whitney Wooderchak-Donahue , Iris Schrijver , Karen E Weck

DOI: 10.5858/ARPA.2010-0623-OA

关键词:

摘要: N Context.—DNA sequencing is the method of choice for mutation detection in many genes. Objectives.—To demonstrate analytical accuracy and reliability DNA assays developed clinical laboratories. Only general guidelines exist validation these tests. We provide examples assay strategies Design.—We discuss important design considerations.

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