The importance of quality assurance in molecular genetic laboratories

Summary

Several challenges arise from the wide application of molecular genetic analyses, among them the need to introduce rules to evaluate molecular genetic test systems as well as test laboratories. This article specifically addresses laboratories performing molecular genetic tests for diagnosis, prevention and therapy of various diseases. The topics that will be discussed will support these laboratories to achieve and sustain a high quality and avoid mistakes and errors. The article covers important preanalytic, analytic and postanalytic aspects in regard to molecular genetic testing as well as quality management issues. In addition laboratory responsibilities, training of personnel, data protection issues, as well as informed consent aspects will be discussed. Beyond that, some molecular genetic methods will be dealt with in regard to potential quality criteria.

Zusammenfassung

Aus dem recht breiten Einsatz der molekularbiologischen Analytik ergeben sich eine Reihe von Herausforderungen wie z. B. die Notwendigkeit der Einführung von Regeln zur Überprüfung der Qualität der Tests sowie der Testlabors. Die nachstehenden Ausführungen des Artikels richten sich speziell an Labors, die genetische Untersuchungen zur Diagnose, Behandlung und Prävention von Erkrankungen einsetzen. Die vorgestellten Themen sollen zur Sicherstellung einer hohen Qualität von genetischen Testlabors und zur Vermeidung von Fehlern beitragen. Es werden wichtige präanalytische, analytische und postanalytische Aspekte sowie das Qualitätsmanagement der molekulargenetischen Diagnostik besprochen. Darüber hinaus werden Laborverantwortlichkeiten, Ausbildung des Personals, Datenschutz sowie Aufklärung bzw. Einverständnis der Patienten zum Test diskutiert. Weiters wird kurz auf molekulargenetische Testmethoden und deren Anforderungen eingegangen.

Keywords

Quality management - molecular genetic testing

Schlüsselwörter

Qualitätsmanagement - molekulargenetische Diagnostik

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