Evaluation of Alinity m CMV assay performance for detecting CMV in plasma, cerebrospinal fluid, and bronchoalveolar lavage specimens

Abstract

AbstractIntroductionRapid and accurate detection of cytomegalovirus (CMV) infection and reactivation is crucial to preventing adverse outcomes in immunocompromised individuals, especially in transplant recipients. Current PCR-based assays were developed for use with plasma specimens, but CMV is present in bronchoalveolar lavage fluid (BAL) in immunocompromised patients with CMV pneumonia and has also been detected in cerebrospinal fluid (CSF).ObjectivesWe evaluated the performance of the Abbott Alinity m CMV assay compared to the Abbott RealTime CMV assay for quantification of CMV in plasma, BAL, and CSF specimens.MethodsAnalytical performance, including linearity, precision, and limit of detection, was established for plasma, BAL, and CSF specimen types using reference CMV control material (SeraCare). To evaluate clinical performance, 190 plasma specimens, 78 BAL specimens, and 26 CSF specimens were tested with the Alinity m assay and compared to the RealTime CMV assay.ResultsThe Alinity m CMV assay showed high precision (SD <0.01 to 0.13) within the quantifiable range (1.49-8.00 log10 IU/mL) for all 3 specimen types, with strong clinical correlation to the RealTime CMV assay results (r2=0.9779 for plasma, r2=0.9373 for BAL, r2=0.9889 for CSF).ConclusionThe Alinity m CMV assay may be useful for rapid detection of CMV in plasma, BAL, and CSF specimens.