CLSI MM22
Microarrays for Diagnosis and Monitoring of Infectious Diseases
CLSI MM22 offers expert advice for the laboratory development and use of qualitative nucleic acid microarray methods in the diagnosis and monitoring of infectious diseases. It also includes guidance on validation and verification, quality control, and the interpretation of results.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline MM22—Microarrays for Diagnosis and Monitoring of Infectious Diseases discusses the wide variety of nucleic acid microarray technologies that a growing number of medical laboratories have adopted for diagnostic testing. The different types of microarrays and their uses in various types of laboratories have grown tremendously. MM22 specifically discusses infectious diseases detection, identification, and genotyping, as well as drug resistance determinants. This guideline describes types of microarray platforms and general considerations in microarray development. It also provides recommendations for validation and verification of microarray performance and QC and QA considerations and discusses parameters for data analysis and interpretation.
This guideline replaces MM22-A, published in 2014. Several changes were made in this edition, including:
• Updating platform overview to include newer technologies now in use for microarray tests
• Adding a new subchapter to describe an individualized quality control plan, which permits the laboratory to customize its QC plan
• Reorganizing content to correspond to the path of workflow
• Adding a process flow chart
This guideline specifies the requirements and/or recommendations for the use of microarrays for diagnosis and monitoring of microbial infections. It covers infectious diseases pathogen detection and identification, genotyping (strain characterization), and virulence and resistance genetic markers. The intended users of this guideline are clinical and molecular microbiology laboratories, including bacteriology, mycobacteriology, mycology, parasitology, and virology.
This guideline may also serve as a reference for government agencies and industry. MM22 is not intended to provide manufacturing guidelines. Protein microarrays and microarray applications for unknown pathogen discovery, host gene expression profiling, or host genomic polymorphism determination related to microbial infections are not included. Sequencing as a detection and identification method is not covered by this guideline (see CLSI documents MM09 and MM18).
Clinical and Laboratory Standards Institute guideline MM22—Microarrays for Diagnosis and Monitoring of Infectious Diseases discusses the wide variety of nucleic acid microarray technologies that a growing number of medical laboratories have adopted for diagnostic testing. The different types of microarrays and their uses in various types of laboratories have grown tremendously. MM22 specifically discusses infectious diseases detection, identification, and genotyping, as well as drug resistance determinants. This guideline describes types of microarray platforms and general considerations in microarray development. It also provides recommendations for validation and verification of microarray performance and QC and QA considerations and discusses parameters for data analysis and interpretation.
This guideline replaces MM22-A, published in 2014. Several changes were made in this edition, including:
• Updating platform overview to include newer technologies now in use for microarray tests
• Adding a new subchapter to describe an individualized quality control plan, which permits the laboratory to customize its QC plan
• Reorganizing content to correspond to the path of workflow
• Adding a process flow chart
This guideline specifies the requirements and/or recommendations for the use of microarrays for diagnosis and monitoring of microbial infections. It covers infectious diseases pathogen detection and identification, genotyping (strain characterization), and virulence and resistance genetic markers. The intended users of this guideline are clinical and molecular microbiology laboratories, including bacteriology, mycobacteriology, mycology, parasitology, and virology.
This guideline may also serve as a reference for government agencies and industry. MM22 is not intended to provide manufacturing guidelines. Protein microarrays and microarray applications for unknown pathogen discovery, host gene expression profiling, or host genomic polymorphism determination related to microbial infections are not included. Sequencing as a detection and identification method is not covered by this guideline (see CLSI documents MM09 and MM18).