Statistical treatment of fluorescence in situ hybridization validation data to generate normal reference ranges using excel functions

Abstract

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