{
  "abstract": "Background: Serum free light chain (sFLC) testing is central to the diagnosis and monitoring of plasma cell disorders, but assay availability and implementation can vary by laboratory setting. We evaluated a domestic latex-enhanced immunoturbidimetric Kehua serum sFLC assay against Freelite and N Latex systems.\n\nMethods: Residual serum samples from 133 adults with suspected or established monoclonal gammopathies were measured in parallel by Kehua and Freelite; 122 were also tested by N Latex. Precision was assessed with low- and high-level serum controls. Method agreement was evaluated using correlation, Passing-Bablok regression, Bland-Altman analysis, qualitative concordance and comparator-defined ROC analysis.\n\nResults: Kehua within-run CVs were <5% for κ and λ controls. Agreement with Freelite was excellent for FLC-κ, FLC-λ and κ/λ ratio (Pearson r = 0.988-1.000; CCC = 0.983-0.999), with Passing-Bablok slopes close to unity. Agreement with N Latex was also strong (r = 0.991-0.998), although κ/λ ratio showed proportional bias. Total qualitative concordance was 89.47-93.23% versus Freelite and 83.61-91.80% versus N Latex, with Cohen’s κ of 0.67-0.85. Comparator-defined ROC AUCs were 0.994-0.999 for elevated FLC-κ or FLC-λ and 0.796-0.869 for κ/λ ratio abnormality.\n\nConclusion: The Kehua serum assay demonstrated acceptable precision and good clinical agreement with two imported methods. It may serve as a domestic option for routine serum sFLC quantification, provided method-specific intervals are maintained and the same platform is used for serial monitoring.",
  "abstract_shown": true,
  "affiliations": [
    "State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College",
    "Shanghai Kehua Bio-Engineering Co., Ltd, Reagent R and D Center"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Yansong Ren"
    },
    {
      "affs": [
        0
      ],
      "name": "Shoulei Wang"
    },
    {
      "affs": [
        1
      ],
      "name": "Limin Han"
    },
    {
      "affs": [
        0
      ],
      "name": "Yansheng Wang"
    },
    {
      "affs": [
        0
      ],
      "name": "Qian Ren"
    },
    {
      "affs": [
        0
      ],
      "name": "Mengxin Wang"
    },
    {
      "affs": [
        0
      ],
      "name": "Yonghui Xia"
    },
    {
      "affs": [
        0
      ],
      "name": "Guoqing Zhu"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/addjbw1bcs77v.bib",
  "cited_by": 0,
  "doi": "10.3389/fonc.2026.1900671",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13716613/?tool=EBI",
  "id": "addjbw1bcs77v",
  "issns": [
    "2234-943X"
  ],
  "landing_url": "https://www.frontiersin.org/articles/10.3389/fonc.2026.1900671/full",
  "language": "eng",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Research"
    ],
    [
      "openalex",
      "2720|Multiple Myeloma Research and Treatments"
    ]
  ],
  "openalex": "W7221956738",
  "pdf_url": "https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2026.1900671/pdf",
  "pmcid": "PMC13716613",
  "pmid": "42959044",
  "published": "2026-10-15",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/addjbw1bcs77v.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:13Z",
      "native_id": "10.3389/fonc.2026.1900671",
      "source": "crossref",
      "url": "https://www.frontiersin.org/articles/10.3389/fonc.2026.1900671/full"
    },
    {
      "first_seen": "2026-10-31T00:20:37Z",
      "native_id": "PMC:PMC13716613",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13716613"
    },
    {
      "first_seen": "2026-11-01T00:20:36Z",
      "native_id": "MED:42959044",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42959044"
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    {
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      "native_id": "PMC13716613",
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      "url": "https://doi.org/10.3389/fonc.2026.1900671"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "issn:2234-943X",
      "subfield": "oncology"
    }
  ],
  "title": "Consistency and correlation of a domestic Kehua serum free light chain assay with two imported analytical systems",
  "title_text": "Consistency and correlation of a domestic Kehua serum free light chain assay with two imported analytical systems",
  "type": "peer-reviewed",
  "updated_at": "2026-11-02T12:21:06Z",
  "url": "https://research.draconitic.com/paper/addjbw1bcs77v",
  "venue": "Frontiers in Oncology",
  "versions": []
}