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Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing.

Marcia J Holden1, Roberta M Madej, Philip Minor

  • 1National Institute of Standards and Technology, 100 Bureau Drive, MS 8312, Gaithersburg, MD 20899-8312, USA. marcia.holden@nist.gov

Expert Review of Molecular Diagnostics
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Summary

Harmonizing nucleic acid testing is crucial due to diverse methods and lack of standards. This article offers tools on reference materials, standards, and proficiency testing for molecular diagnostic labs.

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Area of Science:

  • Molecular Diagnostics
  • Clinical Genetics
  • Infectious Disease Testing

Background:

  • Variability in nucleic acid testing results among laboratories is a significant challenge.
  • This variability stems from numerous assay methods, a wide range of diagnostic targets, and a lack of standard reference materials.

Purpose of the Study:

  • To provide a comprehensive overview of reference materials, documentary standards, and proficiency testing programs in nucleic acid testing.
  • To explore the interrelationships among these resources.
  • To offer practical tools and information for molecular diagnostic laboratories.

Main Methods:

  • Review and synthesis of existing literature and resources on reference materials, standards, and proficiency testing.
  • Exploration of the practical application and integration of these resources in laboratory settings.

Main Results:

  • Identification of key reference materials, documentary standards, and proficiency testing programs relevant to nucleic acid testing.
  • Explanation of the relationships and synergy between these components for improving test accuracy and consistency.
  • Provision of essential information often acquired informally, crucial for laboratory practice.

Conclusions:

  • Standardization through reference materials, documentary standards, and proficiency testing is essential for harmonizing nucleic acid testing.
  • This article serves as a valuable resource, consolidating critical information for molecular diagnostic laboratories to enhance their practices.
  • Implementing these tools can lead to more reliable and comparable test results across different laboratories.