CLSI MM05

Nucleic Acid Amplification Assays for Molecular Hematopathology, 2nd Edition

This guideline addresses the performance and application of assays for gene rearrangement and translocations by both polymerase chain reaction (PCR) and reverse-transcriptase PCR techniques, and includes information on specimen collection, sample preparation, test reporting, test validation, and quality assurance.

This document is available in electronic format only.

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Chairholder: Daniel E. Sabath, MD, PhD

Date of Publication: March 30, 2012

Order Code PDF: CLSI MM05A2E
ISBN Number: 1-56238-791-X

Order Code Print: print not available

Edition: Second

Pages: 108

CLSI MM05 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of July 2021. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI MM05 Abstract

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