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

Area of Science:

• Virology
• Clinical Diagnostics
• Molecular Biology

Background:

• Epstein-Barr virus (EBV) reactivation poses a significant risk for post-transplant lymphoproliferative disorders (PTLD) in immunocompromised individuals, particularly within the first year post-transplant.
• Quantitative molecular testing for EBV viral load is crucial for monitoring and predicting PTLD risk.
• High-sensitivity and high-specificity nucleic acid amplification tests (NAATs) on automated platforms enhance diagnostic accuracy and turnaround time.

Purpose of the Study:

• To evaluate the analytical and clinical performance of the Alinity m EBV assay for quantitative Epstein-Barr virus detection.
• To assess the assay's precision, limit of detection, and correlation with established EBV testing methods.

Main Methods:

• Analytical performance, including limit of detection and precision, was determined using commercial panels.
• Clinical performance was evaluated by comparing the Alinity m EBV assay results with those from established laboratory-developed tests (LDTs) and a commercial assay (Roche cobas EBV) using remnant patient specimens.
• Statistical analysis included correlation coefficients and mean bias calculations.

Main Results:

• The Alinity m EBV assay demonstrated a limit of detection of 1.3 Log IU/mL and high precision (1.9%–5.2% CV).
• Correlations with reference assays were strong, with coefficients ranging from 0.762 to 0.970.
• Mean bias values indicated comparable performance across different comparison groups.

Conclusions:

• The Alinity m EBV assay exhibits high analytical precision and accuracy across its measurement range.
• Results are comparable to established EBV assays, supporting its utility in clinical settings.
• The Alinity m EBV assay is a valuable tool for managing EBV infection in transplant recipients, aiding in PTLD risk assessment.