{
  "abstract": "Objective Recent evidence supports diagnosing coeliac disease without biopsy in patients with significantly elevated tissue transglutaminase (IgA-tTG) antibodies. However, the implementation of this no-biopsy approach relies on accurate and consistent serological testing across laboratories. In this nationwide survey, we aimed to evaluate the availability and variability of coeliac disease testing across the UK.Methods We conducted a cross-sectional telephone survey of biomedical scientists and laboratory managers from National Health Service trusts and health boards across England, Wales, Scotland, and Northern Ireland. Data collected included assay types, reporting methods, upper limit of normal (ULN) thresholds, turnaround times, total IgA testing, and anti-endomysial antibodies (EMAs) availability.Results A total of 356 sites were approached, with a 96% response rate (n=342). Of responding sites, 177 performed coeliac serology tests in-house, while 165 transferred samples externally. Among sites performing tests, 12 different IgA-tTG assays were identified, with considerable variability in ULN thresholds ranging from 3 to 30 IU/mL, even within laboratories using the same assays. The median turnaround time for IgA-tTG results was 7 days (range 1–21 days). Only 43% of laboratories routinely measured total IgA when IgA-tTG was requested. EMA testing was available in 83% of laboratories.Conclusion Significant variability exists in coeliac serology testing across UK laboratories which poses a challenge for the implementation of the no-biopsy approach in clinical practice. Efforts to standardise serological testing are urgently needed. Until such standardisation is achieved, local assay validation remains critical.",
  "authors": [
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospitals of Leicester NHS Trust, Leicester, England, UK"
      ],
      "name": "Albin Alex"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, St George’s Healthcare NHS Trust, London, England, UK"
      ],
      "name": "Alex S Hong"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospitals of Leicester NHS Trust, Leicester, England, UK"
      ],
      "name": "Marcus Dimmock"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospitals of Leicester NHS Trust, Leicester, England, UK"
      ],
      "name": "Mohammad I Zaman"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospitals of Leicester NHS Trust, Leicester, England, UK"
      ],
      "name": "Mohamed Adam"
    },
    {
      "affiliations": [
        "Department of Immunology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England, UK"
      ],
      "name": "Graeme Wild"
    },
    {
      "affiliations": [
        "Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England, UK"
      ],
      "name": "Hugo A Penny"
    },
    {
      "affiliations": [
        "Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England, UK"
      ],
      "name": "David S Sanders"
    },
    {
      "affiliations": [
        "Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"
      ],
      "name": "Penny Whiting"
    },
    {
      "affiliations": [
        "Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"
      ],
      "name": "Martha M C Elwenspoek"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, University Hospitals of Leicester NHS Trust, Leicester, England, UK"
      ],
      "name": "Mohamed G Shiha"
    },
    {
      "affiliations": [],
      "name": "CD No-biopsy Study Group"
    }
  ],
  "title": "Nationwide survey of coeliac disease serology testing in the UK",
  "uid": "c79b1655-f0a9-58c1-9d93-312dc2e19936"
}