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Molecular Methods for Genotyping and Strain Typing of Infectious Organisms, 1st Edition

This guideline examines the biology behind molecular strain typing and genotyping, as well as characterization and validation of these systems. It also provides recommendations regarding criteria to be considered for design, validation, and determination of clinical utility of such testing.

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Chairholder: Ted E. Schutzbank, PhD, D(ABMM)

Date of Publication: September 30, 2021

Order Code PDF: CLSI MM24Ed1E
ISBN Number: 978-1-68440-127-7

Order Code Print: CLSI MM24Ed1
ISBN Number: 978-1-68440-126-0

Edition: First

Pages: 178

CLSI MM24 Abstract

Molecular genotyping and strain typing are essential tools for the analysis of infectious etiological agents of human diseases isolated during investigations of epidemiological outbreaks, laboratory contamination, and recurrent infection. A wide variety of genotyping and strain typing methods have been described using contemporary nucleic acid–based technologies. These methods are used for identifying virulence factors, drug resistance, markers of disease progression within an institution or a community, and in certain cases, patient prognosis. Clinical and Laboratory Standards Institute guideline MM24—Molecular Methods for Genotyping and Strain Typing of Infectious Organisms examines the biology behind molecular genotyping and strain typing and the process of characterizing and validating typing systems. The prevalent methods currently being used in laboratories that perform genotyping and strain typing include nucleic acid amplification tests, ribotyping, sequence-based typing (Sanger and next-generation sequencing), hybridization-based typing methods (microarrays, line-probe arrays), molecular fingerprinting (pulse-field gel electrophoresis, restriction fragment-length polymorphism analysis, multiple locus variable–number of tandem repeat analysis), and protein-based typing. Each of these areas is described in detail specific to the genotyping and strain typing of nucleic acid in clinical testing and monitoring, particularly in bacterial, fungal, and viral diseases. This guideline also includes an update on technologies used for molecular genotyping and strain typing, sample preparation, standards, calibrators, reference materials, analytical and clinical verification/validation, reporting and interpreting results, and clinical utility.