An international multi-site study to evaluate the analytical and clinical performance of the quantitative high-throughput Alinity m CMV assay

Cytomegalovirus (CMV) has a high prevalence in the general population and lifelong latency once an individual is infected. Primary infection or reactivation of CMV in immunocompromised individuals can lead to serious illness, organ failure, and death. Precise and accurate quantification of CMV is a valuable tool to support clinical decision-making and prevent adverse outcomes in transplant recipients. This international multicenter study evaluated the analytical performance of the Alinity m CMV assay using a commercially available panel (2.30 to 6.60 Log IU/mL) and clinical performance compared to the Abbott RealTime CMV assay and Roche cobas CMV assay run on the cobas 6800 system using deidentified remnant plasma specimens. Analysis of analytical precision with the commercial panel revealed a %CV of ≤6.6% and a total SD of ≤0.18 Log IU/mL. Plasma specimens (n = 748) initially tested with the RealTime CMV assay and subsequently run on the Alinity m CMV assay demonstrated a correlation coefficient of 0.972 with a mean bias of -0.05 Log IU/mL. Comparison of the Alinity m CMV and cobas CMV assays utilizing a separate set of plasma specimens (n = 303) demonstrated a correlation coefficient of 0.979 with a mean bias of 0.09 Log IU/mL. The overall percent agreement between Alinity m CMV and RealTime CMV assay results and between Alinity m CMV and cobas CMV assay results at clinically relevant thresholds was ≥95.7% and ≥96.4%, respectively. The high precision, accuracy, and comparable clinical performance of the Alinity m CMV assay, combined with rapid results reporting, support its use in transplant patient management.IMPORTANCECytomegalovirus (CMV) in transplant patients can lead to adverse health consequences. Viral load monitoring is important in post-transplant patient care. Clinical diagnostic laboratories utilize various molecular diagnostic platforms. This study evaluated the Alinity m CMV assay with two commercially available assays: the Abbott RealTime CMV and Roche cobas CMV assays. Our results demonstrated a strong correlation between Alinity m CMV and the comparator assays, ensuring comparable results across these platforms.