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Preparation and Gene Modification of Nonhuman Primate Hematopoietic Stem and Progenitor Cells
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Genetic reference materials and their application to haematology.

J R Hawkins1, M Hawkins, J Boyle

  • 1National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN63QG, United Kingdom. ross.hawkins@nibsc.hpa.org.uk

Biologicals : Journal of the International Association of Biological Standardization
|March 30, 2010
PubMed
Summary

A global shortage of certified genetic reference materials hinders accurate genetic testing. This study developed internationally recognized human genomic DNA reference materials to improve genetic test validation and assay development worldwide.

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Area of Science:

  • Genomics
  • Biotechnology
  • Clinical Diagnostics

Background:

  • Genetic testing is crucial in human health but lacks certified reference materials.
  • This deficiency impedes test validation and the development of new genetic assays.
  • Existing genetic tests may be run without well-validated controls, impacting accuracy.

Purpose of the Study:

  • To address the worldwide lack of certified genetic reference materials (GRMs).
  • To establish internationally accredited GRMs for genetic testing.
  • To improve the development and validation of genetic assays and diagnostic tests.

Main Methods:

  • Established cell lines from phenotypically characterized patients for consistent DNA supply.
  • Bulk cultivation of cell lines for genomic DNA extraction (up to 100 mg).
  • Formulated, freeze-dried, and sealed DNA in glass ampoules for enhanced stability and transport.

Main Results:

  • Developed the first internationally recognized reference materials for human genomic DNA.
  • Created stable, easy-to-transport DNA reference materials.
  • Focused on genetic tests common in hematological and cardiovascular laboratories.

Conclusions:

  • The developed genetic reference materials provide essential tools for accurate genetic testing.
  • These materials facilitate international accreditation and worldwide distribution.
  • The program establishes a foundation for improved quality control in genetic diagnostics.