CLSI MM17
Validation and Verification of Multiplex Nucleic Acid Assays
Nucleic acid testing is one of the fastest-growing fields in laboratory medicine. This guideline includes recommendations for the analytical validation and verification of multiplex assays, along with a review of biological and synthetic reference materials.
The document is available exclusively in electronic format.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline MM17—Validation and Verification of Multiplex Nucleic Acid Assays discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical validity and utility are briefly reviewed. Because of the variety and breadth of multiplex testing, specific protocols for validation and verification are not included. However, detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided.
This document is available in electronic format only.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
Clinical and Laboratory Standards Institute guideline MM17—Validation and Verification of Multiplex Nucleic Acid Assays discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical validity and utility are briefly reviewed. Because of the variety and breadth of multiplex testing, specific protocols for validation and verification are not included. However, detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided.
This document is available in electronic format only.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.