{
  "abstract": "Background/Objectives: Patient-based real-time quality control (PBRTQC) complements traditional internal quality control. This study validates a ratio-based PBRTQC integrating department clustering with inter-instrument ratio monitoring. Methods: Creatinine data (384,730 cases, 2025) from three measuring systems (A, B, C) were analyzed; conventional PBRTQC on unstratified Instrument A data served as comparator. Departments were stratified by K-means clustering of annual mean/SD, keeping the low-mean cluster (124 departments). The data of each measuring system were split chronologically: first-layer PBRTQC was trained on the first part, the second trained the ratio programs, and the third provided independent validation. Three systematic errors (fixed additive offsets of +5.28 and +10.56 μmol/L, and a progressive offset rising to +10.56 μmol/L, corresponding to 6% and 12% of the first-layer action limit) were simulated to assess the true positive rate (TPR), false positive rate (FPR), median samples to detection (MNPed), detection time and diagnostic odds ratio (DOR). Results: Under the fixed +5.28 μmol/L (6%) offset, A-B TPR was 28.83% versus 6.77% for traditional PBRTQC, with MNPed reduced from 34 to 20. Under the progressive offset rising to +10.56 μmol/L (12%), A-B TPR was 29.00% versus 8.35%, and detection time fell from 20 to 14 min. Under the fixed +10.56 μmol/L (12%) offset, A-B and A-C TPR reached 70.15% and 74.72% (MNPed 8 and 5; detection time 2 and 1 min). Across all scenarios the ratio programs achieved higher DOR. A stratified single-instrument comparator showed complementary contributions of stratification and ratio monitoring (TPR at the +5.28 μmol/L offset: 6.77%, 15.61% and 28.83%). Conclusions: Integrating department stratification with ratio-based PBRTQC markedly improves detection of small systematic errors in creatinine testing, albeit with more false positives, offering a transferable framework for laboratories using multiple same-platform measuring systems.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Clinical Laboratory, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.",
    "Department of Clinical Laboratory, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Xuemei Wei",
      "orcid": "0009-0005-1585-6674"
    },
    {
      "affs": [
        0
      ],
      "name": "Ziqing Jiang"
    },
    {
      "affs": [
        1
      ],
      "name": "Jingzhu Nan",
      "orcid": "0000-0002-3003-424X"
    },
    {
      "affs": [
        0
      ],
      "name": "Zefeng Yan"
    },
    {
      "affs": [
        0
      ],
      "name": "Zhu Lin",
      "orcid": "0000-0002-4800-2393"
    },
    {
      "affs": [
        0
      ],
      "name": "Rong Li"
    },
    {
      "affs": [
        0
      ],
      "name": "Jie Feng",
      "orcid": "0000-0001-6969-9356"
    },
    {
      "affs": [
        0
      ],
      "name": "Yanhong Gao"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/eqyk29t66f2qh.bib",
  "cited_by": 0,
  "doi": "10.3390/diagnostics16193238",
  "fulltext_url": "https://europepmc.org/articles/PMC13664551",
  "id": "eqyk29t66f2qh",
  "issns": [
    "2075-4418"
  ],
  "landing_url": "https://europepmc.org/article/MED/42882393",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2737|Clinical Laboratory Practices and Quality Control"
    ]
  ],
  "openalex": "W7221004079",
  "pdf_url": "https://europepmc.org/articles/PMC13664551?pdf=render",
  "pmcid": "PMC13664551",
  "pmid": "42882393",
  "published": "2026-10-07",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/eqyk29t66f2qh.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:00Z",
      "native_id": "MED:42882393",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42882393"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2737|Clinical Laboratory Practices and Quality Control",
      "subfield": "physiology"
    }
  ],
  "title": "A Two-Tier Patient-Based Real-Time Quality Control Program Integrating K-Means Department Stratification and Inter-Instrument Ratios Improves Detection of Small Systematic Errors in Creatinine Testing.",
  "title_text": "A Two-Tier Patient-Based Real-Time Quality Control Program Integrating K-Means Department Stratification and Inter-Instrument Ratios Improves Detection of Small Systematic Errors in Creatinine Testing.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:19:00Z",
  "url": "https://research.draconitic.com/paper/eqyk29t66f2qh",
  "venue": "Diagnostics (Basel, Switzerland)",
  "versions": []
}