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Alinity m BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma (K2 EDTA, K3 EDTA, and PPT) and urine stabilized using the Alinity m Urine Transport Kit on the automated Alinity m System.

In EDTA plasma (K2 EDTA, K3 EDTA, and PPT) and urine stabilized using the Alinity m Urine Transport Kit, Alinity m BKV is intended for use as an aid in the diagnosis and management of BKV in transplant patients.

In patients undergoing monitoring of BKV in EDTA plasma, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.

The results from Alinity m BKV must be interpreted in conjunction with clinical signs and other relevant laboratory findings. Alinity m BKV is not cleared as a screening test for blood or blood products or human cells, tissues, and cellular and tissue-based products.

Device Description

The Alinity m BKV assay utilizes real-time polymerase chain reaction (PCR) to amplify and detect BKV genomic DNA sequences that have been extracted from human EDTA plasma or urine specimens. The steps of the Alinity m BKV assay consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. One transfer step of urine specimens into the Alinity m Urine Transport Kit by the user is required prior to placing urine specimens on the Alinity m System. Remaining steps of the Alinity m BKV assay procedure are executed automatically by the Alinity m System. Manual dilutions may be performed for low-volume plasma specimens to meet the minimum volume requirement. The Alinity m System is designed to be a randomaccess analyzer that can perform the Alinity m BKV assay in parallel with other Alinity m assays on the same instrument.

Alinity m BKV requires three separate assay specific kits as follows:

. Alinity m BKV AMP Kit (List No. 09N85-095), consisting of 2 types of multi-well assay trays. The amplification tray (AMP TRAY 1) contains liquid, unit-dose PCR amplification/detection reagents and liquid, unit-dose Internal Control (IC) in separate wells; and the activation tray (ACT TRAY 2) contains liquid, unit-dose activation reagent. The intended storage condition for the Alinity m BKV AMP Kit is -25°C to -15°C.
. Alinity m BKV CTRL Kit (List No. 09N85-085), consisting of negative controls, low positive controls, and high positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m BKV CTRL Kit is -25°C to -15°C.
Alinity m BKV CAL Kit (List No. 09N85-075), consisting of 2 calibrator levels, . each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m BKV CAL Kit is -25°C to -15°C.

The Alinity m BKV assay requires a transport kit for testing all urine specimens:

Alinity m Urine Transport Kit (List No. 09N85-001) consisting of a transport tube . and transfer pipette. The transport tube contains transport buffer. The intended storage condition for the Alinity m Urine Transport Kit is 15℃ to 30℃.
BKV DNA from human plasma or urine is extracted automatically on board the Alinity m System using the Alinity m Sample Prep Kit 2, Alinity m Lysis Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified DNA is then combined with liquid unit-dose Alinity m BKV activation reagent and liquid unit-dose Alinity m BKV amplification/detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to the reaction vessel which is then transferred to an amplification/detection unit for PCR amplification and real-time fluorescence detection of BKV DNA.

At the beginning of the Alinity m BKV sample preparation process, a liquid unit-dose IC on the AMP Tray is transferred by the Alinity m System and delivered into each sample preparation reaction. The IC is then processed through the entire sample preparation and real-time PCR procedure along with the specimens, calibrators, and controls to demonstrate proper sample processing and validity.

The Alinity m BKV amplification/detection reagents consist of enzymes, primers, probes, and activation reagents that enable amplification and detection of dual targets in the BKV genome. Amplification and detection of the two BKV targets ensures sensitive detection of the viral genome even at low levels. In addition to the BKV primers and probes, the assay utilizes an IC primer/probe set for amplification and detection of the IC target sequence, which is not related to BKV. The IC probe is labeled with a different fluorophore than the BKV probes. This allows for simultaneous detection and discrimination of both the BKV and IC amplified products within the same reaction vessel.

A BKV calibration curve is required for determination of BKV DNA concentration. Two levels of calibrators are processed through sample preparation and PCR to generate the calibration curve. The concentration of BKV DNA in specimens and controls is then calculated from the stored calibration curve.

Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remains satisfactory. During each control event, a negative control, a low-positive control, and a high positive control are processed through sample preparation and PCR procedures that are identical to those used for specimens.

The Alinity m BKV assay also utilizes the following:

Alinity m BKV Application Specification File (List No. 09N85-05A) .
Alinity m System and System Software (List No. 08N53-002)
Alinity m Sample Prep Kit 2 (List No. 09N12-001)
. Alinity m Specimen Dilution Kit I (List No. 09N50-001)
. Alinity m System Solutions, (List No. 09N20):
- o Alinity m Lysis Solution (List No. 09N20-001)
- o Alinity m Diluent Solution (List No. 09N20-003)
- o Alinity m Vapor Barrier Solution, (List No. 09N20-004)
Alinity m Tubes and Caps (List No. 09N49): •
- Alinity m LRV Tube (List No. 09N49-001) o
- o Alinity m Transport Tubes Pierceable Capped (List No. 09N49-010)
- o Alinity m Transport Tube (List No. 09N49-011)
- o Alinity m Pierceable Cap (List No. 09N49-012)
- o Alinity m Aliquot Tube (List No. 09N49-013)

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Plasma Performance	Urine Performance
Limit of Detection (LoD) (95% detection probability)	Claimed LoD: 50 IU/mL (1.70 Log IU/mL)	Claimed LoD: 50 IU/mL (1.70 Log IU/mL)
(Genotypes Ia, Ic, II, III, IV detection at ≥95%)	All genotypes detected at ≥95% at 30 IU/mL (1.48 Log IU/mL)	All genotypes detected at ≥95% at 45 IU/mL (1.65 Log IU/mL)
Linear Range (Quantitation Range)	50 IU/mL (1.70 Log IU/mL) to 1,000,000,000 IU/mL (9.00 Log IU/mL) (r=1.000)	50 IU/mL (1.70 Log IU/mL) to 1,000,000,000 IU/mL (9.00 Log IU/mL) (r=1.000)
(Linearity for Genotypes)	Established for Ia, Ic, II, III, IV across the quantitation range	Established for Ia, Ic, II, III, IV across the quantitation range
Precision (Within-laboratory SD for Log IU/mL)	≤ 0.25 Log IU/mL for 2.70-9.00 Log IU/mL; ≤ 0.50 Log IU/mL for 1.70-0.4% w/v) and PBMCs (>1 × 10^5 cells/mL).
Carryover	0.0% (95% CI: 0.0% to 1.1%)	0.0% (95% CI: 0.0% to 1.1%)
Clinical Agreement (Plasma)	High agreement with comparator across viral load ranges: 100% for TND, 100% for

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