Table of Contents
Abstract
CommitteeMembership
Foreword
1Scope
2Introduction
3StandardPrecautions
4Terminology
5Safety
6StrategicPlanning
7PatientSamplesandNucleicAcidExtraction
8ImplementationPlan
9QualityManagementSystem
10DevelopingaQualityManagementSystem
11UniqueConsiderationsforDifferentLaboratory
Specialties
References
AppendixA-RegulatoryRequirements
AppendixB-TechnologyOverviewandPlatforms
AppendixC-ExamplesofTechnologyAvailableto
DetectInfectiousDiseases
TheQualityManagementSystemApproach
RelatedCLSIReferenceMaterials Abstract
Specifies comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics.
