Workshop - Validation of diagnostic tests in clinical molecular genetics


Genetic tests must be validated before diagnostic use to ensure that they perform according to the laboratory's requirements, and test validation is a formal requirement of many accreditation standards including ISO 15189. In this workshop, we will examine the validation requirements of ISO 15189 and address practical ways of meeting them in your laboratory.

Topics will include:

  • terms and definitions
  • defining the elements to be validated
  • approaches to validating specific tests
  • approaches to validating general methods
  • determining uncertainty
  • writing a validation report
  • ongoing (follow-up) validation.

Common misunderstandings regarding validation will be discussed, and case studies and group discussion will be used to illustrate the theoretical aspects and to help you develop practical strategies for your laboratory.

Target group

The target audience of this workshop are lab directors, lab technicians, lab scientists and quality coordinators.
Focus is on clinical molecular genetics laboratories.
The number of participants is limited to 25.
The workshops are in English.

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Center for Human Genetics
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