Royal Hallamshire Hospital, Sheffield, United Kingdom; University of Sheffield, Sheffield, United Kingdom.
University of Sheffield, Sheffield, United Kingdom.
Clin Gastroenterol Hepatol. 2015 Jul;13(7):1278-1284.e1. doi: 10.1016/j.cgh.2015.01.010. Epub 2015 Jan 26.
BACKGROUND & AIMS: Celiac disease is underdiagnosed. Many patients are examined by endoscopy, but celiac disease is missed or not detected. We evaluated the accuracy of finger prick-based point-of-care tests in the detection of celiac disease and developed an algorithm for diagnosis.
We performed a prospective study of 2 groups of patients with celiac disease evaluated at the Royal Hallamshire Hospital in Sheffield (United Kingdom) from March 2013 through February 2014. In group 1, patients at high risk of celiac disease who tested positive for endomysial antibody (n = 55) were evaluated using the Biocard test (BHR Pharmaceuticals, Nuneaton, UK) and the Celiac Quick Test (Biohit Healthcare UK, Ellesmere Port, UK), which measure antibodies to tissue transglutaminase (anti-tTG), and the Simtomax test (Tillotts Pharma, Rheinfelden, Switzerland), which measures deamidated gliadin peptide antibodies (DGP). Patients in group 2 (508 consecutive patients who underwent an endoscopy examination for any indication) received the DGP test, and also were evaluated using a diagnostic algorithm that incorporated results from the DGP test and data on symptoms. In both groups, point-of-care tests were taken at the time of endoscopy and results were compared with results from histologic analyses of duodenal biopsy specimens from all patients.
In group 1, the DGP test identified patients with celiac disease with 94.4% sensitivity, the Celiac Quick Test identified patients with 77.8% sensitivity (P = .03 vs the DGP test), and the Biocard test identified patients with 72.2% sensitivity (P = .008 vs the DGP test). In group 2, the DGP test identified patients with celiac disease with 92.7% sensitivity (95% confidence interval, 83.0-97.3), 85.2% specificity (95% confidence interval, 81.5-88.3), a positive predictive value of 49.2% (95% confidence interval, 40.3-58.2), and a negative predictive value of 98.7% (95% confidence interval, 96.8-99.5). Measurement of serum anti-tTG identified patients with celiac disease with 91.2% sensitivity (95% confidence interval, 81.1-96.4), 87.5% specificity (95% confidence interval, 84.0-90.4), a positive predictive value of 53.0% (95% confidence interval, 43.6-62.2), and a negative predictive value of 98.5% (95% confidence interval, 96.5-99.4). The algorithm identified patients with celiac disease with 98.5% sensitivity; its use could reduce duodenal biopsies by 35%.
In a prospective study, a test for DGP identified patients with celiac disease with similar levels of sensitivity and specificity as standard serologic analysis of anti-tTG. Use of the DGP test before endoscopy could increase the accuracy of the diagnosis of celiac disease. Further studies, in lower-prevalence populations, are required to assess the impact of the test in clinical practice.
乳糜泻的诊断率较低。许多患者接受了内镜检查,但仍可能漏诊或未能检出乳糜泻。我们评估了基于指尖的即时检测在乳糜泻检测中的准确性,并制定了诊断算法。
我们对 2013 年 3 月至 2014 年 2 月在谢菲尔德皇家哈利姆沙尔医院接受评估的 2 组乳糜泻患者进行了前瞻性研究。在第 1 组中,对高风险乳糜泻患者(内肌抗体阳性,n=55)进行了生物卡检测(BHR 制药公司,纳尼顿,英国)和 Celiac Quick Test(Biohit Healthcare UK,埃尔斯米尔港,英国),检测组织转谷氨酰胺酶(抗 tTG)抗体,以及 Simtomax 检测(Tillotts Pharma,雷宁根,瑞士),检测脱酰胺麦胶肽抗体(DGP)。第 2 组(508 例因任何原因接受内镜检查的连续患者)接受了 DGP 检测,并采用包含 DGP 检测结果和症状数据的诊断算法进行评估。在两组中,均在进行内镜检查时进行了即时检测,将结果与所有患者的十二指肠活检组织学分析结果进行比较。
在第 1 组中,DGP 检测识别出乳糜泻患者的敏感性为 94.4%,Celiac Quick Test 检测识别出乳糜泻患者的敏感性为 77.8%(P=0.03 与 DGP 检测相比),而 Biocard 检测识别出乳糜泻患者的敏感性为 72.2%(P=0.008 与 DGP 检测相比)。在第 2 组中,DGP 检测识别出乳糜泻患者的敏感性为 92.7%(95%置信区间,83.0-97.3),特异性为 85.2%(95%置信区间,81.5-88.3),阳性预测值为 49.2%(95%置信区间,40.3-58.2),阴性预测值为 98.7%(95%置信区间,96.8-99.5)。检测血清抗 tTG 识别出乳糜泻患者的敏感性为 91.2%(95%置信区间,81.1-96.4),特异性为 87.5%(95%置信区间,84.0-90.4),阳性预测值为 53.0%(95%置信区间,43.6-62.2),阴性预测值为 98.5%(95%置信区间,96.5-99.4)。该算法识别出乳糜泻患者的敏感性为 98.5%;使用该算法可减少 35%的十二指肠活检。
在一项前瞻性研究中,DGP 检测识别乳糜泻患者的敏感性和特异性与抗 tTG 的标准血清学分析相似。在进行内镜检查之前进行 DGP 检测可以提高乳糜泻诊断的准确性。需要在低患病率人群中进一步研究,以评估该检测在临床实践中的影响。