A Comprehensive Statistical Framework for Determination of Commutability, Accuracy, and Agreement in Clinical DNAemia Assays.

Despite advances in the standardization of quantitative DNAemia tests and efforts to better understand and characterize the performance of reference materials in different assays, it remains unclear how the commutability performance of reference materials is related to intra- and interassay agreement. Building upon previous work, we describe a comprehensive framework to determine the relationship of commutability with assay accuracy and agreement. The use of this framework is illustrated using previously generated data regarding the performance of four quantitative Epstein-Bar virus (EBV) PCR assays with the WHO and ABI standards as examples. The use of these statistical tools can link the performance characteristics of one or more assays with predetermined clinical decision limits and may help improve the development, validation, and clinical utility of such DNAemia tests.