Standard Document
First Edition
Molecular Diagnostics

CLSI MM12

Diagnostic Nucleic Acid Microarrays

This CLSI guideline provides best practices for operating diagnostic nucleic acid microarrays. It covers nucleic acid extraction, genetic material assessment, quality control, validation, and result interpretation. The guideline supports array-based detection of DNA variations, gene expression analysis, methylation profiling, pathogen detection, antibiotic resistance analysis, and comparative genomic hybridization.

May 30, 2006
Joseph L. Hackett, PhD

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Abstract

Clinical and Laboratory Standards Institute document MM12-A, Diagnostic Nucleic Acid Microarrays; Approved Guideline provides general recommendations for the operation of diagnostic nucleic acid microarrays. The recommendations cover nucleic acid extraction; preparation, handling, and assessment of genetic material; and interpretation and reporting of results. The guideline addresses array-based detection of variations in DNA sequence and gene expression analysis as it relates to: heritable variations, somatic changes, methylation profiling, pathogen profiling including antibiotic resistance analysis, expression profiling, and gene dosage/comparative genomic hybridization.

Scope

MM12—Diagnostic Nucleic Acid Microarrays addresses array-based detection of variations in DNA sequence and gene expression analysis as it relates to: 

• Heritable variations 

• Somatic changes

• Methylation profiling 

• Pathogen profiling, including antibiotic resistance analysis

• Expression profiling

• gene dosage/comparative genomic hybridization (CGH). 

This guideline provides recommendations for many aspects of the microarray process, including: a method overview; nucleic acid extraction; the preparation, handling, and assessment of genetic material; and interpretation and reporting of results. Quality control, as well as analytical and clinical validation, is also addressed. This guideline is limited to clinically relevant targets and does not address tissue and protein microarrays, non-nucleic acid microarrays, or research applications of microarrays.

Product Details
MM12AE
1-56238-608-5
124
Additional Details

This document is available in electronic format only.

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

A CLSI-IFCC joint project.

Authors
Joseph L. Hackett, PhD
Kellie J. Archer, PhD
Adolfas K. Gaigalas, PhD
Carleton T. Garrett, MD, PhD
Loren J. Joseph, MD
Walter H. Koch, PhD
L. J. Kricka, D Phil
Ronald C. McGlennen, MD
Vivianna Van Deerlin, MD, PhD
Gregory B. Vasquez, PhD
Abstract

Clinical and Laboratory Standards Institute document MM12-A, Diagnostic Nucleic Acid Microarrays; Approved Guideline provides general recommendations for the operation of diagnostic nucleic acid microarrays. The recommendations cover nucleic acid extraction; preparation, handling, and assessment of genetic material; and interpretation and reporting of results. The guideline addresses array-based detection of variations in DNA sequence and gene expression analysis as it relates to: heritable variations, somatic changes, methylation profiling, pathogen profiling including antibiotic resistance analysis, expression profiling, and gene dosage/comparative genomic hybridization.

Scope

MM12—Diagnostic Nucleic Acid Microarrays addresses array-based detection of variations in DNA sequence and gene expression analysis as it relates to: 

• Heritable variations 

• Somatic changes

• Methylation profiling 

• Pathogen profiling, including antibiotic resistance analysis

• Expression profiling

• gene dosage/comparative genomic hybridization (CGH). 

This guideline provides recommendations for many aspects of the microarray process, including: a method overview; nucleic acid extraction; the preparation, handling, and assessment of genetic material; and interpretation and reporting of results. Quality control, as well as analytical and clinical validation, is also addressed. This guideline is limited to clinically relevant targets and does not address tissue and protein microarrays, non-nucleic acid microarrays, or research applications of microarrays.

Additional Details

This document is available in electronic format only.

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

A CLSI-IFCC joint project.

Authors
Joseph L. Hackett, PhD
Kellie J. Archer, PhD
Adolfas K. Gaigalas, PhD
Carleton T. Garrett, MD, PhD
Loren J. Joseph, MD
Walter H. Koch, PhD
L. J. Kricka, D Phil
Ronald C. McGlennen, MD
Vivianna Van Deerlin, MD, PhD
Gregory B. Vasquez, PhD