Molecular Diagnostics: Harmonization and Standardization: Abstract and Introduction

From Expert Review of Molecular Diagnostics

Molecular Diagnostics

Harmonization Through Reference Materials, Documentary Standards and Proficiency Testing

Marcia J Holden; Roberta M Madej; Philip Minor; Lisa V Kalman

Authors and Disclosures

Posted: 12/02/2011; Expert Rev Mol Diagn. 2011;11(7):741-755. © 2011 Expert Reviews Ltd.

 

• Abstract and Introduction
• The Need for Standardization in Molecular Genetics & Infectious Disease Testing
• Reference Materials
• Reference Materials With Established Quantitative Properties
• Reference Materials With Nominal Properties
• Documentary Standards
• Proficiency Testing: Ongoing Standardization & Assessment
• Expert Commentary
• Five-year View

• References
• Sidebar

Abstract and Introduction

Abstract

There is a great need for harmonization in nucleic acid testing for infectious disease and clinical genetics. The proliferation of assay methods, the number of targets for molecular diagnostics and the absence of standard reference materials contribute to variability in test results among laboratories. This article provides a comprehensive overview of reference materials, related documentary standards and proficiency testing programs. The article explores the relationships among these resources and provides necessary information for people practicing in this area that is not taught in formal courses and frequently is obtained on an ad hoc basis. The aim of this article is to provide helpful tools for molecular diagnostic laboratories.

 

Section 1 of 9

Next: The Need for Standardization in Molecular Genetics & Infectious Disease Testing  »

Molecular Diagnostics: Harmonization and Standardization: Abstract and Introduction