Performance evaluation of the high-throughput quantitative Alinity m Epstein-Barr virus assay.

Abstract

Molecular testing for Epstein-Barr virus (EBV) infection is a cornerstone of care to prevent adverse outcomes in immunocompromised patients, including transplant recipients. We evaluated the analytical and clinical performance of the quantitative Alinity m EBV assay for plasma sample testing on the fully automated Alinity m platform. Assay lower limit of detection and precision were determined using commercially available panels in plasma. Alinity m EBV detected 100% of panels at 1.3 Log IU/mL, and precision ranged from 1.9% to 5.2% coefficients of variance (SD ≤ 0.14 Log IU/mL). Remnant-de-identified specimens initially tested with the Eurofins Viracor EBV Laboratory Developed Test (LDT) (n = 357), ELITech EBV LDT (n = 113), University of Washington (UW) LDT (n = 151), or Roche cobas EBV assay (n = 148) were subsequently tested with the Alinity m EBV assay. Comparison of the Alinity m EBV assay and Eurofins Viracor EBV assay demonstrated a correlation coefficient of 0.762 and mean bias of -0.48 Log IU/mL, comparison of the Alinity m EBV assay with UW LDT demonstrated a correlation coefficient of 0.970 and mean bias of -0.24 Log IU/mL, and comparison of the Alinity m EBV assay with cobas EBV demonstrated a correlation coefficient of 0.964 and mean bias of 0.35 Log IU/mL. The Alinity m EBV assay demonstrated high precision across the analytical measurement range and produced comparable results to the EBV test of record assays. These findings support the utility of the fully automated Alinity m EBV assay in transplant patient management.

Importance: Epstein-Barr virus (EBV) infection and reactivation are associated with increased risk for post-transplant lymphoproliferative disorders (PTLD) in transplant recipients with the development of PTLD occurring predominantly within a year of transplant. Quantitative PCR for EBV is used to monitor the viral load of EBV with a negative result as a good negative predictor of PTLD. Nucleic acid amplification tests (NAATs) with high sensitivity and specificity are available on fully automated high-throughput instruments to provide accurate quantitation and improve test result turn-around time. This study evaluates the analytical and clinical performance of one such NAAT, the Alinity m EBV assay.