Multicenter evaluation of Alinity m BKV assay in plasma and urine: Comparison with laboratory-developed tests across three centers
6 affiliations
- 1Microbiology Laboratory, The Royal Melbourne Hospital, Australia
- 2Department of Laboratory Medicine, Seoul National University Hospital, Seoul, Republic of Korea
- 3Victorian Infectious Disease Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia
- 4Molecular Diagnostics of Abbott, Des Plaines, IL, USA
- 5Molecular Diagnostics, Abbott Laboratories (Singapore) Pte Ltd, Singapore
- 6Victorian Infectious Disease Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia; Corresponding author.
Abstract
Background: Historically, laboratories have relied on laboratory-developed tests (LDTs) for BK polyomavirus (BKPyV) monitoring; however, variation in assay designs and calibration hinder consistent interpretation across laboratories. Objective: To evaluate analytical performance of Alinity m BKV and compare qualitative, quantitative agreement and workflow with two clinically validated LDTs. Methods: Linearity, precision, and analytical specificity were assessed, along with plasma (n = 390) and urine (n = 57) remnant de-identified specimens. Qualitative agreement was evaluated using overall/positive/negative percent agreement (OPA/PPA/NPA) and Cohen’s kappa (κ). Quantitative comparison was assessed using Bland-Altman and Deming regression to characterize agreement and linear relationship. Workflow metrics were derived descriptively from Alinity m system logs and LDT’s standard operating times. Results: Alinity m BKV demonstrated linear response over the evaluated range, robust precision across matrices, and no cross-reactivity. In plasma, qualitative agreement was high versus both RealStar (OPA was 92.0%, κ = 0.77) and ELITe (OPA 97.1%, κ = 0.90) BKV LDTs. Bland-Altman analysis showed mean biases of -1.31 and -0.84 log 10 IU/mL versus RealStar and ELITe BKV LDT, respectively. In urine,qualitative agreement with RealStar was 100%, and the mean bias was +0.11 log 10 IU/mL among 25 quantifiable paired specimens. Total analytical processing time was shorter on Alinity m than the RealStar and ELITe workflows. Conclusion: Alinity m BKV assay demonstrated favorable analytical performance, high qualitative agreement and reduced processing time. Systematic quantitative differences were observed in plasma, and likely reflect multifactorial differences in assay design, calibration, processing, and pre-analytical conditions. These findings support laboratory implementation but do not establish clinical interchangeability across platforms.
Related
- Evaluation of the Alinity m HIV-1 assay for early infant diagnosis using dried blood spots in resource-limited settings
- Development and validation of a laboratory-developed test on Panther Fusion(R) system for detection of macrolide resistance in Bordetella pertussis
- Laboratory-Developed NGS Panel for Characterization of Advanced Colorectal Cancer, Real-World Data from a Tertiary Referral Centre.
- Evaluation of risk stratification at presentation using the Alinity high-sensitivity cardiac troponin I assay
- Laboratory-based nutritional risk assessment including GDF15 in cirrhosis: a multicenter retrospective study
BibTeX
@article{francis2026multicenter,
title = {{Multicenter evaluation of Alinity m BKV assay in plasma and urine: Comparison with laboratory-developed tests across three centers}},
author = {Michelle Francis and Jee-Soo Lee and Megan Gooey and Doris Chibo and Elaine Lee and Sung Im Cho and Katherine Bond and Rose Cotronei and Moon-Woo Seong and Danijela Lucic and Yan Chin Tai and Kathy Jackson},
journal = {Journal of Clinical Virology Plus},
year = {2026},
month = oct,
doi = {10.1016/j.jcvp.2026.100271},
url = {https://doi.org/10.1016/j.jcvp.2026.100271},
note = {CC BY},
}
RIS
TY - JOUR
TI - Multicenter evaluation of Alinity m BKV assay in plasma and urine: Comparison with laboratory-developed tests across three centers
AU - Michelle Francis
AU - Jee-Soo Lee
AU - Megan Gooey
AU - Doris Chibo
AU - Elaine Lee
AU - Sung Im Cho
AU - Katherine Bond
AU - Rose Cotronei
AU - Moon-Woo Seong
AU - Danijela Lucic
AU - Yan Chin Tai
AU - Kathy Jackson
PY - 2026
DA - 2026/10/30
JO - Journal of Clinical Virology Plus
DO - 10.1016/j.jcvp.2026.100271
UR - https://doi.org/10.1016/j.jcvp.2026.100271
AB - Background: Historically, laboratories have relied on laboratory-developed tests (LDTs) for BK polyomavirus (BKPyV) monitoring; however, variation in assay designs and calibration hinder consistent interpretation across laboratories. Objective: To evaluate analytical performance of Alinity m BKV and compare qualitative, quantitative agreement and workflow with two clinically validated LDTs. Methods: Linearity, precision, and analytical specificity were assessed, along with plasma (n = 390) and urine (n = 57) remnant de-identified specimens. Qualitative agreement was evaluated using overall/positive/negative percent agreement (OPA/PPA/NPA) and Cohen’s kappa (κ). Quantitative comparison was assessed using Bland-Altman and Deming regression to characterize agreement and linear relationship. Workflow metrics were derived descriptively from Alinity m system logs and LDT’s standard operating times. Results: Alinity m BKV demonstrated linear response over the evaluated range, robust precision across matrices, and no cross-reactivity. In plasma, qualitative agreement was high versus both RealStar (OPA was 92.0%, κ = 0.77) and ELITe (OPA 97.1%, κ = 0.90) BKV LDTs. Bland-Altman analysis showed mean biases of -1.31 and -0.84 log 10 IU/mL versus RealStar and ELITe BKV LDT, respectively. In urine,qualitative agreement with RealStar was 100%, and the mean bias was +0.11 log 10 IU/mL among 25 quantifiable paired specimens. Total analytical processing time was shorter on Alinity m than the RealStar and ELITe workflows. Conclusion: Alinity m BKV assay demonstrated favorable analytical performance, high qualitative agreement and reduced processing time. Systematic quantitative differences were observed in plasma, and likely reflect multifactorial differences in assay design, calibration, processing, and pre-analytical conditions. These findings support laboratory implementation but do not establish clinical interchangeability across platforms.
SN - 2667-0380
ER -