CLSI MM21
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
CLSI MM21 offers comprehensive advice for the validation, verification, performance, and interpretation of nucleic acid microarrays used in cytogenetic applications. It covers the measurement of copy number imbalances and loss of heterozygosity, addressing both constitutional and oncology applications.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document MM21—Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications discusses nucleic acid microarray technologies for diagnostic testing that a growing number of medical laboratories have adopted. The different types of microarrays and their uses in various types of laboratories have grown tremendously. MM21 specifically addresses validation, verification, performance, and interpretation of nucleic acid microarrays used for cytogenetic applications to measure copy number imbalances and loss of heterozygosity. Both constitutional and oncology applications are discussed.
This guideline provides recommendations for the appropriate performance, validation or verification, and interpretation of nucleic acid microarrays used primarily for cytogenetic applications to measure copy number (CN) imbalances, traditional array-based comparative genomic hybridization (aCGH), and single nucleotide polymorphism (SNP) arrays for CN imbalances and absence of heterozygosity (AOH). Both constitutional (prenatal/postnatal) and oncology applications are addressed.
The intended users of this guideline are clinical genetics laboratorians who perform cytogenetics and molecular genetics testing. This guideline:
• Is not intended for research laboratorians
• Is not intended to provide guidance to manufacturers
• Does not address methylation arrays, RNA expression microarrays, resequencing and genotyping arrays not intended for CN detection, microarrays for the diagnosis and monitoring of infectious diseases, or non-nucleic acid microarrays (eg, protein arrays)
This document is available in electronic format only.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
Clinical and Laboratory Standards Institute document MM21—Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications discusses nucleic acid microarray technologies for diagnostic testing that a growing number of medical laboratories have adopted. The different types of microarrays and their uses in various types of laboratories have grown tremendously. MM21 specifically addresses validation, verification, performance, and interpretation of nucleic acid microarrays used for cytogenetic applications to measure copy number imbalances and loss of heterozygosity. Both constitutional and oncology applications are discussed.
This guideline provides recommendations for the appropriate performance, validation or verification, and interpretation of nucleic acid microarrays used primarily for cytogenetic applications to measure copy number (CN) imbalances, traditional array-based comparative genomic hybridization (aCGH), and single nucleotide polymorphism (SNP) arrays for CN imbalances and absence of heterozygosity (AOH). Both constitutional (prenatal/postnatal) and oncology applications are addressed.
The intended users of this guideline are clinical genetics laboratorians who perform cytogenetics and molecular genetics testing. This guideline:
• Is not intended for research laboratorians
• Is not intended to provide guidance to manufacturers
• Does not address methylation arrays, RNA expression microarrays, resequencing and genotyping arrays not intended for CN detection, microarrays for the diagnosis and monitoring of infectious diseases, or non-nucleic acid microarrays (eg, protein arrays)
This document is available in electronic format only.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.