JMD GMP oligos for in vitro Diagnostics
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Originally published online as doi:10.2353/jmoldx.2009.080101 on June 12, 2009

Published online before print June 12, 2009
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Journal of Molecular Diagnostics 2009, Vol. 11, No. 4
Copyright © 2009 American Society for Investigative Pathology & Association for Molecular Pathology
DOI: 10.2353/jmoldx.2009.080101

Statistical Treatment of Fluorescence in Situ Hybridization Validation Data to Generate Normal Reference Ranges Using Excel Functions

Allison L. Ciolino, Mary E. Tang and Ron Bryant

From the Department of Pathology, University of Vermont College of Medicine/Fletcher Allen Health Care, Burlington, Vermont

Fluorescent in situ hybridization has become an essential tool for diagnosing and monitoring hematological disease. Testing for minimal residual disease requires precise and accurate normal cut-offs. There is no consensus in the field on the correct method of establishing a normal reference range. We discuss and compare several proposed statistical methods to calculate normal reference ranges, including Gaussian statistics, the β inverse function, and a binomial treatment of the data. We demonstrate that a binomial treatment of the data is an accurate and simple method to calculate a normal reference range.






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Copyright © 2009 by the American Society for Investigative Pathology and the Association for Molecular Pathology.