Alinity m BKV

The Alinity m BKV is an in vitro nucleic acid amplification test that quantifies BK virus DNA in human EDTA plasma and urine specimens stabilized using the Alinity m Urine Transport Kit. It is intended for use as an aid in diagnosis and management of BKV in transplant patients, with serial measurements helping guide treatment decisions.

The Alinity m BKV uses real-time PCR amplification with dual BKV genome targets (two highly conserved regions) and an internal control for sample validity, as opposed to the predicate device's small T-antigen and VP2 targets. Both employ automated magnetic microparticle-based nucleic acid extraction and automated liquid handling on their respective platforms.

The device was evaluated against the 1st World Health Organization International Standard for BK virus (NIBSC code: 14/212). Traceability to this WHO standard was established through primary calibrators and product calibrators at defined concentrations.

The Alinity m BKV is substantially equivalent because it shares the same intended use (quantitative BKV detection for transplant patient management), uses the same amplification technology (real-time PCR), processes the same specimen types (EDTA plasma and stabilized urine), employs similar automated sample preparation and detection methods, and demonstrates clinically acceptable analytical performance (LoD 50 IU/mL, linear range 50–1,000,000,000 IU/mL, high precision and specificity). Although the assay targets differ, both are dual-target approaches within the BKV genome, and clinical comparison studies with 579 plasma and 380 urine specimens showed strong agreement with the FDA-cleared predicate device.