title: Quantitative Assessment of Commutability for Clinical Viral Load Testing Using a Digital PCR-Based Reference Standard.
abstract: Given recent advances in the development of quantitative standards, particularly WHO international standards, efforts to better understand the commutability of reference materials have been made. Existing approaches in evaluating commutability include prediction intervals and correspondence analysis; however, the results obtained from existing approaches may be ambiguous. We have developed a "deviation-from-ideal" (DFI) approach to evaluate commutability of standards and applied it to the assessment of Epstein-Bar virus (EBV) load testing in four quantitative PCR assays, treating digital PCR as a reference assay. We then discuss advantages and limitations of the DFI approach as well as experimental design to best evaluate the commutability of an assay in practice.
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: L
authors.initials: L
authors.lastname: Tang
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: D
authors.initials: D
authors.lastname: Buelow
authors.affiliation: Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Z
authors.initials: Z
authors.lastname: Gu
authors.affiliation: Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Caliendo
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: S
authors.initials: S
authors.lastname: Pounds
authors.affiliation: Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA randall.hayden@stjude.org.
authors.forename: R T
authors.initials: RT
authors.lastname: Hayden
mesh_terms: D004854:Herpesvirus 4, Human / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods* / Q000592:standards*; D012015:Reference Standards; D019562:Viral Load / Q000379:methods* / Q000592:standards*