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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.

Product Details

Edition:
2nd
Published:
05/31/2018
ISBN(s):
9781684400041
Number of Pages:
118
File Size:
1 file , 2.6 MB