Diagnostic validation

With respect to quality assurance and laboratory accreditation requirements, all laboratories have to generate and validate Standard Operating Procedures (SOPs), for all the methods in use. However, although validation is required for accreditation, there is little consensus on definitions or guidelines of what is acceptable or appropriate in the field of medical genetics.

A standardized framework for the validation and verification of clinical molecular genetic tests.

Publication pubmed link:" A standardized framework for the validation and verification of clinical molecular genetic tests."

The validation and verification of laboratory methods and procedures before their use in clinical testing is essential for providing a safe and useful service to clinicians and patients. This paper outlines the principles of validation and verification in the context of clinical human molecular genetic testing. We describe implementation processes, types of tests and their key validation components, and suggest some relevant statistical approaches that can be used by individual laboratories to ensure that tests are conducted to defined standards.

Validation reports

Multiplex Ligation-dependent Probe Amplification (MLPA)

Validation Report: Multiplex Ligation-dependent Probe Amplification (MLPA)

Achived/Related documents:


Automated DNA Extraction

Technology Assessment Report: Integration of the Chemagen Magnetic DNA Separator with the Perkin Elmer MultiProbe II Liquid Handler

Achived/Related documents:

High resolution melting (HRM)

Other documents

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