Alex Albin, Hong Alex S, Dimmock Marcus, Zaman Mohammad I, Adam Mohamed, Wild Graeme, Penny Hugo A, Sanders David S, Whiting Penny, Elwenspoek Martha M C, Shiha Mohamed G
Department of Gastroenterology, University Hospitals of Leicester NHS Trust, Leicester, England, UK.
Department of Gastroenterology, St George's Healthcare NHS Trust, London, England, UK.
BMJ Open Gastroenterol. 2025 Aug 5;12(1):e001900. doi: 10.1136/bmjgast-2025-001900.
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.
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.
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.
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.
近期证据支持，对于组织转谷氨酰胺酶（IgA - tTG）抗体显著升高的患者，可不通过活检来诊断乳糜泻。然而，这种无需活检方法的实施依赖于各实验室准确且一致的血清学检测。在这项全国性调查中，我们旨在评估英国各地乳糜泻检测的可及性和变异性。
我们对来自英格兰、威尔士、苏格兰和北爱尔兰的国民健康服务信托机构及健康委员会的生物医学科学家和实验室管理人员进行了横断面电话调查。收集的数据包括检测方法类型、报告方式、正常上限（ULN）阈值、周转时间、总IgA检测以及抗肌内膜抗体（EMA）的可及性。
共联系了356个机构，回复率为96%（n = 342）。在回复的机构中，177个机构内部进行乳糜泻血清学检测，而165个机构将样本外送检测。在进行检测的机构中，共识别出12种不同的IgA - tTG检测方法，ULN阈值差异很大，范围从3至30 IU/mL，即使在使用相同检测方法的实验室中也是如此。IgA - tTG结果的中位周转时间为7天（范围1 - 21天）。当要求检测IgA - tTG时，只有43%的实验室常规检测总IgA。83%的实验室可进行EMA检测。
英国各实验室的乳糜泻血清学检测存在显著差异，这对临床实践中实施无需活检的方法构成了挑战。迫切需要努力使血清学检测标准化。在实现这种标准化之前，本地检测方法的验证仍然至关重要。
