Fully Automated Quantification of Cytomegalovirus (CMV) in Whole Blood with the New Sensitive Abbott RealTi m e CMV Assay in the Era of the CMV International Standard

Fully standardized reproducible and sensitive quantification assays for cytomegalovirus (CMV) are needed to better define thresholds for antiviral therapy initiation and interruption. We evaluated the newly released Abbott RealTi m e CMV assay for CMV quantification in whole blood (WB) that includes automated extraction and amplification ( m 2000 RealTi m e system). Sensitivity, accuracy, linearity, and intra- and interassay variability were validated in a WB matrix using Quality Control for Molecular Diagnostics (QCMD) panels and the WHO international standard (IS). The intra- and interassay coefficients of variation were 1.37% and 2.09% at 5 log 10 copies/ml and 2.41% and 3.80% at 3 log 10 copies/ml, respectively. According to expected values for the QCMD and Abbott RealTi m e CMV methods, the lower limits of quantification were 104 and