OECD Guidelines for Quality Assurance in Genetic Testing

 

 

http://www.oecd.org/sti/biotech/oecdguidelinesforqualityassuranceingenetictesting.htm

 

 

OECD member countries have adopted an agreed set of Guidelines for Quality Assurance in Molecular Genetic Testing. The Guidelines address genetic testing for variations in germ line DNA sequences or products arising directly from changes in heritable genomic sequences that predict effects on the health, or influence the health management, of an individual. They focus on molecular genetic testing for the diagnosis of a particular disease or condition and predictive genetic testing often carried out before any clinical signs of the disease or condition appear. They are relevant to tests for heritable DNA variants that predict the response profile of an individual to a drug or course of therapy and that affect susceptibility to disease, patient prognosis, counselling, treatment and family planning. They do not address testing carried out only for research purposes.

 

 

Table of Contents

 

Background..............................................................................5

Preface ......................................................................................7

Part I. Principles and Best Practices for Quality Assurance of Molecular Genetic Testing......................11

   1. Scope............................................................................11

   2. Principles and best practices .............................13

  General principles and best practices for molecular genetic testing ..........................13

  Quality assurance systems in molecular genetic testing..............................................14

  Proficiency testing: monitoring the quality of laboratory performance......................16

  Quality of result reporting...........................................................................................17

  Education and training standards for laboratory personnel.......................................19

 

Part II. Annotations.........................................................................................................21

  Introduction..................................................................................................................23

  General terminology ....................................................................................................23

  General principles and practices for molecular genetic testing ..................................26

  Quality assurance systems in molecular genetic testing..............................................29

  Proficiency testing: Monitoring the quality of laboratory performance......................31

  Ensuring quality in molecular genetic test result reporting.........................................33

  Education and training standards for laboratory personnel .......................................35

 

Glossary ...........................................................................................................................37