{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "Microbiology Laboratory, The Royal Melbourne Hospital, Australia",
    "Department of Laboratory Medicine, Seoul National University Hospital, Seoul, Republic of Korea",
    "Victorian Infectious Disease Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia",
    "Molecular Diagnostics of Abbott, Des Plaines, IL, USA",
    "Molecular Diagnostics, Abbott Laboratories (Singapore) Pte Ltd, Singapore",
    "Victorian Infectious Disease Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia; Corresponding author."
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Michelle Francis"
    },
    {
      "affs": [
        1
      ],
      "name": "Jee-Soo Lee"
    },
    {
      "affs": [
        2
      ],
      "name": "Megan Gooey"
    },
    {
      "affs": [
        2
      ],
      "name": "Doris Chibo"
    },
    {
      "affs": [
        2
      ],
      "name": "Elaine Lee"
    },
    {
      "affs": [
        1
      ],
      "name": "Sung Im Cho"
    },
    {
      "affs": [
        0
      ],
      "name": "Katherine Bond"
    },
    {
      "affs": [
        0
      ],
      "name": "Rose Cotronei"
    },
    {
      "affs": [
        1
      ],
      "name": "Moon-Woo Seong"
    },
    {
      "affs": [
        3
      ],
      "name": "Danijela Lucic"
    },
    {
      "affs": [
        4
      ],
      "name": "Yan Chin Tai"
    },
    {
      "affs": [
        5
      ],
      "name": "Kathy Jackson"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/8w7pk8qbt8w3h.bib",
  "cited_by": 0,
  "doi": "10.1016/j.jcvp.2026.100271",
  "fulltext_url": "http://www.sciencedirect.com/science/article/pii/S2667038026000311",
  "id": "8w7pk8qbt8w3h",
  "issns": [
    "2667-0380"
  ],
  "landing_url": "https://doi.org/10.1016/j.jcvp.2026.100271",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "lcc",
      "RC109-216"
    ],
    [
      "openalex",
      "2730|Polyomavirus and related diseases"
    ]
  ],
  "openalex": "W7222940639",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-30",
  "publisher": "Elsevier",
  "ris": "https://research.draconitic.com/paper/8w7pk8qbt8w3h.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T13:47:20Z",
      "native_id": "60094d3ca6f2488ea73425b9c1af867a",
      "source": "doaj",
      "url": "https://doi.org/10.1016/j.jcvp.2026.100271"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|Polyomavirus and related diseases",
      "subfield": "oncology"
    }
  ],
  "title": "Multicenter evaluation of Alinity m BKV assay in plasma and urine: Comparison with laboratory-developed tests across three centers",
  "title_text": "Multicenter evaluation of Alinity m BKV assay in plasma and urine: Comparison with laboratory-developed tests across three centers",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:47:20Z",
  "url": "https://research.draconitic.com/paper/8w7pk8qbt8w3h",
  "venue": "Journal of Clinical Virology Plus",
  "versions": []
}