Performance evaluation of the high-throughput quantitative Alinity m BK virus assay

Area of Science:

• Virology
• Immunology
• Clinical Diagnostics

Background:

• BK virus (BKV) infection or reactivation poses significant risks, including BKV-associated nephropathy (BKVAN) in kidney transplant recipients and BKV-associated hemorrhagic cystitis (BKV-HC) in stem cell transplant recipients.
• Monitoring BKV viral load is essential for effective post-transplant patient management and preventing adverse outcomes.

Purpose of the Study:

• To evaluate the performance characteristics of the Alinity m BKV Investigational Use Only (IUO) assay.
• To compare the Alinity m BKV IUO assay with existing BKV detection methods in clinical specimens.

Main Methods:

• Assessed linearity and precision of the Alinity m BKV IUO assay across a dynamic range (2.0-7.3 Log IU/mL).
• Determined the limit of detection at 50 IU/mL.
• Compared results with ELITech MGB Alert BKV LDT (using DNA and TNA extraction), Altona RealStar BKV, and Roche cobas BKV assays in plasma and urine specimens.

Main Results:

• The Alinity m BKV IUO assay exhibited excellent linearity (correlation coefficient of 1.000) and precision (SD ≤ 0.25 Log IU/mL).
• Achieved 100% detection rate at 50 IU/mL.
• Demonstrated strong correlation coefficients (0.900-0.980) and acceptable mean biases when compared to other BKV assays in plasma and urine.

Conclusions:

• The Alinity m BKV IUO assay performs with high precision across its dynamic range.
• The assay shows good correlation with established BKV detection methods, supporting its utility in clinical settings for viral load monitoring.