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 inThe Journal of molecular diagnostics : JMD Vol. 12; no. 2; pp. 133 - 143
Main Authors Madej, Roberta M, Davis, Jack, Holden, Marcia J, Kwang, Stan, Labourier, Emmanuel, Schneider, George J
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.03.2010
ASIP
American Society for Investigative Pathology
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Summary: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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ISSN:1525-1578
1943-7811
DOI:10.2353/jmoldx.2010.090067