CLSI MM05-A2 (R2018)

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Analysis of nucleic acids is playing an increasing role in the diagnosis and management of patients with hematopoieticneoplasms. The tests include those for detection of clonality by analysis of gene rearrangements in the antigen receptor genes ordetection of nonrandom inactivation of the X chromosome, detection and quantification of junctions formed by chromosomaltranslocations, detection of micromutations, quantification of chimerism after allogeneic hematopoietic transplantation, andquantification of normal DNA or RNA sequences. The methods used in clinical molecular hematopathology include end-pointPCR, reverse-transcriptase PCR, real-time fluorescence-based PCR, DNA sequencing, FISH, and hybridization-based microarrayand microbead assays.

Clinical and Laboratory Standards Institute document MM05-A2 – Nucleic Acid Amplification Assays for MolecularHematopathology; Approved Guideline – Second Edition addresses the needs of the laboratory by providing recommendations ona variety of laboratory tests based on analysis of nucleic acids. It addresses preexamination and examination issues affectingassay performance, reporting of laboratory results, and QA. The guideline is designed to assist a molecular diagnostic laboratoryin acquiring a new assay or new technology, as well as serve as a refresher for those already experienced with a particular area ofanalysis.

Product Details

Published:

03/01/2012

ISBN(s):

156238791X

Number of Pages:

108

File Size:

1 file , 2.8 MB