title: 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 beta 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.
authors.affiliation: Department of Pathology and Laboratory Medicine, Fletcher Allen Health Care, Burlington, Vermont 05401, USA.
authors.forename: Allison L
authors.initials: AL
authors.lastname: Ciolino
authors.forename: Mary E
authors.initials: ME
authors.lastname: Tang
authors.forename: Ron
authors.initials: R
authors.lastname: Bryant
mesh_terms: D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000379:methods / Q000592:standards*; D016011:Normal Distribution; D012016:Reference Values; D015203:Reproducibility of Results; D012984:Software