Objective Why about a quarter of patients with inflammatory bowel disease (IBD) suffer symptoms for more than a year before their diagnosis made is unclear. Low public awareness, embarrassment and the apprehension of invasive tests are cited. The anonymity of direct-to-public calprotectin testing may overcome these barriers. We sought to characterise what calprotectin testing is available directly to the public in the UK. Design/method We conducted a cross-sectional evaluation of the calprotectin assays available online in the UK. Collection kits were procured from eligible providers, and surplus stool tested to receive follow-up advice for known positive (>50–100 μg/g) and negative (<50 μg/g) stool samples. Results Half (54.5% (6/11)) of the available tests were home lateral flow tests and the remainder were laboratory-based ELISAs. The lateral flow tests were considerably cheaper than the laboratory-based tests (median (range) cost £14.20 (£7.85–21.00) vs £75.85 (£59–151), p<0.0001). The median turnaround time for the laboratory tests was 14 (range: 1–23) days. All but one provider used a positivity threshold of 50 μg/g. All tests included written and pictorial instructions with the testing kit. Contact with a physician was recommended for similar proportions of positive and negative calprotectin results (54.5% (6/11) vs 54.5% (6/11), p=1). Conclusion In the UK, the public can choose between inexpensive home-based lateral flow tests or send stool samples for gold-standard laboratory testing of calprotectin. The low cost and rapid turnaround times suggest that direct-to-public calprotectin testing could be promoted to try to reduce the time to IBD diagnosis. Data are available upon reasonable request. The data will be made available to investigators whose proposed use of the data has been approved by an independent review committee. Analyses will be restricted to the aims in the approved proposal. Proposals should be directed to Tariq Ahmad (tariq.ahmad1@nhs.net). To gain full access data, requestors will need to sign a data access agreement.

中文翻译：

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在线直接向公众钙卫蛋白检测的横断面评估


目的 为什么大约四分之一的炎症性肠病 (IBD) 患者在诊断前症状持续一年以上尚不清楚。公众意识低下、尴尬和对侵入性检测的担忧。直接向公众进行钙卫蛋白检测的匿名性可能会克服这些障碍。我们试图描述英国公众可以直接进行哪些钙卫蛋白测试。设计/方法 我们对英国在线提供的钙卫蛋白检测进行了横断面评估。收集套件是从符合条件的提供者处购买的，并对剩余粪便进行了测试，以获得已知阳性（>50-100 μg/g）和阴性（<50 μg/g）粪便样本的后续建议。结果 一半 (54.5% (6/11)) 的可用测试是家庭侧向层析测试，其余的是基于实验室的 ELISA。侧向层析测试比基于实验室的测试便宜得多（中位（范围）成本为 14.20 英镑（7.85-21.00 英镑）对比 75.85 英镑（59-151 英镑），p<0.0001）。实验室测试的中位周转时间为 14 天（范围：1-23）天。除一家提供商外，所有提供商均使用 50 μg/g 的阳性阈值。所有测试都包括测试套件的书面和图片说明。对于相似比例的阳性和阴性钙卫蛋白结果，建议与医生联系（54.5% (6/11) vs 54.5% (6/11)，p=1）。结论 在英国，公众可以选择廉价的家庭侧向层析检测或发送粪便样本进行钙卫蛋白金标准实验室检测。低成本和快速的周转时间表明，可以推广直接向公众进行钙卫蛋白检测，以尝试缩短 IBD 诊断时间。数据可根据合理要求提供。 这些数据将提供给研究人员，其数据使用建议已获得独立审查委员会的批准。分析将仅限于已批准提案中的目标。提案应提交至 Tariq Ahmad (tariq.ahmad1@nhs.net)。要获得完全访问数据，请求者需要签署数据访问协议。