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Retaining the Confidence of the Public in Molecular Genetic Testing – Quality Assurance

The introduction of molecular genetic techniques to clinical laboratories opens the possibility of public access to a wide range of tests for many different genetic disorders. This new diagnostic area is still in a transition phase from research to service. Mechanisms for ensuring the quality of genetic testing are not yet in place but need to be developed with some urgency to retain public confidence. External quality assessment (EQA), or proficiency testing, is an independent check on a laboratory’s performance. This paper describes EQA pilot schemes and guidelines for ‘best practice’ developed in Europe and some of the problems involved in introducing quality assurance measures to service providers so that these measures are sustainable. The introduction of accreditation may provide a means of sustaining these systems. Reasons to encourage an international approach to EQA and harmonisation and mutual recognition of national and regional EQA schemes are also discussed.