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Using standards and controls in molecular assays for infectious diseases
1Roche Molecular Systems, Inc, Pleasanton, CA, USA. Roberta_M.Madej@roche.com
Molecular Diagnosis : a Journal Devoted to the Understanding of Human Disease Through the Clinical Application of Molecular Biology
|January 5, 2002
Summary
Clinical laboratories now have more resources for molecular infectious disease diagnostics, including quality assurance programs and guidelines. Evaluating and integrating these new tools with existing regulations remains a key challenge for scientists.
Area of Science:
- Clinical diagnostics
- Molecular infectious diseases
Background:
- Limited resources existed 10 years ago for implementing molecular diagnostics in clinical settings.
- The need for quality assurance in molecular diagnostics has been recognized by various organizations.
Purpose of the Study:
- To present available resources for molecular diagnostics implementation.
- To discuss the harmonization of new practices with existing regulations.
Main Methods:
- Review of available standard reference materials.
- Overview of control materials and external quality assessment programs.
- Analysis of written guidelines for molecular diagnostics.
Main Results:
- Numerous resources like reference materials, controls, and guidelines are now available.
- Progress has been made in harmonizing new molecular diagnostic practices with established regulations.
Conclusions:
- Clinical laboratory scientists face challenges in evaluating and integrating new molecular diagnostic resources.
- Ongoing efforts are needed to address remaining questions in harmonizing new practices with regulations.