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.
Document identifier
CLSI MM17
Title
Verification and Validation of Multiplex Nucleic Acid Assays, 2nd Edition, MM17Ed2E
Publication date
2018-05-31
International Relationship
History of version
CLSI MM17 * CLSI MM17-A
| Price |
140 vnd |
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