Performance evaluation of the NeuMoDx™ EBV Quant Assay 2.0 in Comparison with cobas® EBV for epstein-barr virus DNA quantification in immunocompromised patients, a multicenter study

The NeuMoDx™ EBV Quant Assay 2.0 is an automated test for measuring Epstein-Barr virus (EBV) DNA in plasma samples from immunocompromised transplant patients. This multicenter study aimed to compare the assay's performance with the cobas® EBV test, a widely accepted method for EBV quantification. The study was conducted at five clinical sites across the USA and Europe. A total of 999 samples were analyzed, including both fresh and frozen plasma from immunocompromised transplant patients, as well as contrived samples to cover the full assay dynamic range. The results demonstrated acceptable concordance between the NeuMoDx™ EBV Quant Assay and the cobas® test. Qualitatively, the NeuMoDx™ assay demonstrated a Positive Percent Agreement (PPA) of 95.3 % and a Negative Percent Agreement (NPA) of 95.1 % within the linear range of the assay. Overall, slope regression comparing the two assays was >0.90, but increased variability was observed at the upper and lower limits of the assay's dynamic range. These findings support its use for monitoring EBV in transplant patients, reinforcing the assay's value in clinical diagnostics. The study is registered on clinicaltrials.gov - NCT06681025.