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

ABSTRACT: 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

SUBMITTER: Hirschhorn JW 

PROVIDER: S-EPMC12502681 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature