CLSI MM07

Fluorescence In Situ Hybridization Methods for Clinical Laboratories, 2nd Edition

This document addresses fluorescence in situ hybridization methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification. Recommendations for probe and assay development, manufacture, qualification, verification, and validation; instrument requirements; quality assurance; and evaluation of results are also included.

This document is available in electronic format only.

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Chairholder: James T. Mascarello, PhD

Date of Publication: August 30, 2013

Order Code PDF: CLSI MM07A2E
ISBN Number: 1-56238-886-X

Order Code Print: print not available

Edition: Second

Pages: 60

CLSI MM07 Additional Details

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid of as June 2023. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI MM07 Abstract

Clinical and Laboratory Standards Institute document MM07-A2—Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—Second Edition provides information to ensure appropriate and reliable use of the FISH technology. FISH may be used to detect cytogenetic aberrations that are not readily evident by standard cytogenetic banding analyses. FISH technology allows for rapid identification of deletions, duplications, amplifications, and structural abnormalities of specific genes, loci, or chromosomal DNA/RNA sequences. The regions assessed by FISH are typically larger than those studied with PCR, yet smaller than those visualized microscopically with standard cytogenetics. FISH studies have become routine in medical laboratories.