{
  "abstract": "Recent advances in antibody discovery technologies have profoundly reshaped in vitro diagnostics (IVD). Over the past century, diagnostic antibody development has evolved from serum‐derived polyclonal and hybridoma‐derived monoclonal antibodies to phage display, single‐B‐cell screening, reverse sequencing, and now AI‐assisted design, firmly establishing antibodies as indispensable components of modern IVD systems. Yet as antibody generation grows increasingly scalable, reproducible, and standardized, conventional metrics like affinity and specificity can no longer fully account for assay‐level diagnostic performance, widening the critical gap between binder acquisition and assay‐ready functionality. This review reveals a clear paradigm shift in diagnostic antibody research: from discovery‐centered strategies to assay‐aware, design‐oriented engineering. We organize current progress around four core themes: inherent tradeoffs among major discovery routes; context‐dependent affinity interpretation; key advances in functional antibody engineering; and AI's emerging role linking sequence optimization with structure, developability, and assay translation. A consistent trend emerges: diagnostic antibodies are evolving from passive molecular recognition reagents into engineered, structurally programmable, system‐integrated analytical units. Future IVD advances will thus depend not only on improved molecular recognition, but also on rational design of antibody behavior within complex diagnostic systems.",
  "abstract_shown": true,
  "affiliations": [
    "Chongqing Essence Biological Engineering Chongqing P. R. China",
    "State Key Laboratory of Veterinary Public Health and Safety, College of Veterinary Medicine China Agricultural University Beijing P. R. China",
    "Department of Outpatient Taihe Hospital Hubei University of Medicine Shiyan P. R. China",
    "The Center for Clinical Molecular Medical Detection The First Affiliated Hospital of Chongqing Medical University Chongqing P. R. China",
    "School of Pharmacy and Bioengineering Taihe Hospital Chongqing University of Technology Chongqing P. R. China"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 15,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Qitao Song"
    },
    {
      "affs": [
        0
      ],
      "name": "Lulai Xu"
    },
    {
      "affs": [
        1
      ],
      "name": "Weilin Wu"
    },
    {
      "affs": [
        2
      ],
      "name": "Fei Xie"
    },
    {
      "affs": [
        1
      ],
      "name": "Yantong Pan"
    },
    {
      "affs": [
        3
      ],
      "name": "Tiantian Yang"
    },
    {
      "affs": [
        0
      ],
      "name": "Xiaoxia Xu"
    },
    {
      "affs": [
        0
      ],
      "name": "Yanyin Lin"
    },
    {
      "affs": [
        0
      ],
      "name": "Lihua Zhang"
    },
    {
      "affs": [
        0
      ],
      "name": "Jiahui Zhou"
    },
    {
      "affs": [
        4
      ],
      "name": "Junyou Zhou"
    },
    {
      "affs": [
        4
      ],
      "name": "Linping Li"
    },
    {
      "affs": [
        1
      ],
      "name": "Zhanhui Wang"
    },
    {
      "affs": [
        0
      ],
      "name": "Weijing Yi"
    },
    {
      "affs": [
        0
      ],
      "name": "Jing Wang"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/62sgdqcykm5dj.bib",
  "cited_by": 0,
  "doi": "10.1002/viw.20250218",
  "fulltext_url": "https://doi.org/10.1002/VIW.20250218",
  "id": "62sgdqcykm5dj",
  "issns": [
    "2688-268X",
    "2688-3988"
  ],
  "landing_url": "https://doi.org/10.1002/viw.20250218",
  "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",
      "R855-855.5"
    ],
    [
      "lcc",
      "TP248.13-248.65"
    ],
    [
      "openalex",
      "2741|Monoclonal and Polyclonal Antibodies Research"
    ]
  ],
  "openalex": "W7157307275",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-26",
  "publisher": "Wiley",
  "ris": "https://research.draconitic.com/paper/62sgdqcykm5dj.ris",
  "sources": [
    {
      "first_seen": "2026-10-31T14:21:15Z",
      "native_id": "3879fea6c14d499da13549c136fec210",
      "source": "doaj",
      "url": "https://doi.org/10.1002/viw.20250218"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2741|Monoclonal and Polyclonal Antibodies Research",
      "subfield": "imaging"
    }
  ],
  "title": "Diagnostic antibodies at an inflection point: From discovery platforms to design‐oriented engineering",
  "title_text": "Diagnostic antibodies at an inflection point: From discovery platforms to design‐oriented engineering",
  "type": "peer-reviewed",
  "updated_at": "2026-10-31T14:21:15Z",
  "url": "https://research.draconitic.com/paper/62sgdqcykm5dj",
  "venue": "View",
  "versions": []
}