International Standards and Reference Materials for Quantitative Molecular Infectious Disease Testing
The utility of quantitative molecular diagnostics for patient management depends on the ability to relate patient results to prior results or to absolute values in clinical practice guidelines. To do this, those results need to be comparable across time and methods, either by producing the same valu...
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| Published in | The Journal of molecular diagnostics : JMD Vol. 12; no. 2; pp. 133 - 143 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.03.2010
ASIP American Society for Investigative Pathology |
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| Abstract | The utility of quantitative molecular diagnostics for patient management depends on the ability to relate patient results to prior results or to absolute values in clinical practice guidelines. To do this, those results need to be comparable across time and methods, either by producing the same value across methods and test versions or by using reliable and stable conversions. Universally available standards and reference materials specific to quantitative molecular technologies are critical to this process but are few in number. This review describes recent history in the establishment of international standards for nucleic acid test development, organizations involved in current efforts, and future issues and initiatives. |
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| AbstractList | The utility of quantitative molecular diagnostics for patient management depends on the ability to relate patient results to prior results or to absolute values in clinical practice guidelines. To do this, those results need to be comparable across time and methods, either by producing the same value across methods and test versions or by using reliable and stable conversions. Universally available standards and reference materials specific to quantitative molecular technologies are critical to this process but are few in number. This review describes recent history in the establishment of international standards for nucleic acid test development, organizations involved in current efforts, and future issues and initiatives. |
| Author | Madej, Roberta M Kwang, Stan Labourier, Emmanuel Holden, Marcia J Davis, Jack Schneider, George J |
| AuthorAffiliation | Quality Systems Division, Bio-Rad Laboratories, Diagnostics Group, San Ramon, California Quality Systems Division, Bio-Rad Laboratories, Irvine, California Development, Asuragen, Inc., Austin Texas Roche Molecular Diagnostics, Pleasanton, California Biochemical Science Division, National Institute of Standards and Technology, Gaithersburg, Maryland Research and Development, Abbott Molecular Inc., Des Plaines, Illinois |
| AuthorAffiliation_xml | – name: Research and Development, Abbott Molecular Inc., Des Plaines, Illinois – name: Development, Asuragen, Inc., Austin Texas – name: Quality Systems Division, Bio-Rad Laboratories, Irvine, California – name: Quality Systems Division, Bio-Rad Laboratories, Diagnostics Group, San Ramon, California – name: Roche Molecular Diagnostics, Pleasanton, California – name: Biochemical Science Division, National Institute of Standards and Technology, Gaithersburg, Maryland |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20075208$$D View this record in MEDLINE/PubMed |
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| Copyright | American Society for Investigative Pathology and Association for Molecular Pathology 2010 American Society for Investigative Pathology and Association for Molecular Pathology 2010 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved. 2010 American Society for Investigative Pathology and Association for Molecular Pathology |
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| Title | International Standards and Reference Materials for Quantitative Molecular Infectious Disease Testing |
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