Diagnostic accuracy of a new point-of-care screening assay for celiac disease
Diagnostic accuracy of a new point-of-care screening assay for celiac disease
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DOI：
10.3748/wjg.v19.i31.5111
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发表时间：
2013-08-21
影响因子：
4.3
通讯作者：
Schaeppi, Michela G.
中科院分区：
文献类型：
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作者：
Benkebil, Faiza;Combescure, Christophe;Schaeppi, Michela G.
方法：112例临床症状提示为CD和/或CD患者一级亲属的患者(n=66)，确诊为CD患者的无面筋饮食(GFD)患者(n=46)，在日内瓦大学医院儿科消化内科门诊和消化内科会诊病房进行前瞻性研究。所有登记的受试者都获得了书面知情同意。这项研究得到了当地伦理委员会的批准。最初的CD诊断是基于血清IgA阳性的抗组织转谷氨酰胺酶酶联免疫吸附试验(QuantaLite T，Inova Diagnostics，圣地亚哥，加利福尼亚州，美国)和活检结果。所有研究参与者的血清样本用新的CD横向流动免疫层析分析(CD-LFIA)设备Simtomax(R)血滴(Augurix SA，BioArk，Monhe，Swiss)进行检测，以检测针对去胺化醇溶蛋白多肽的免疫球蛋白(Ig)A和抗体。使用具有95%CI的接收器操作特征曲线来评估诊断性能。结果：CD-LFIA在检测未经治疗的乳糜泻患者时具有较高的准确性。在有CD症状和/或FDR的患者组中，通过ELISA和活检发现了8例新的CD病例。所有这些新病例也都被CD-LFIA正确识别。这项检测产生了四个假阳性和四个假阴性结果。假阳性结果均在临床症状提示CD和/或FDR组内，而假阴性结果均在GFD组内。其敏感性为78.9%(95%CI：54.4~93.9)，特异性为95.7%(95%CI：89.4~98.8)，曲线下面积为0.893(95%CI：0.798~0.988)。卡帕系数为0.96(SE：0.06)，根据两个读取器从同一设备上获得的值计算。剔除GFD患者后，曲线下面积为0.989(95%可信区间：0.971~1.000)，卡帕系数为0.96(SE：0.07)。以无GFD的Rann评分2为界值，其敏感性为100%，特异性为93.1%(95%CI：83.3~98.1)。结论：新的CD-LFIA快速筛查试验具有良好的诊断准确性、敏感性和特异性，可排除CD相关症状。(C)2013年白石登。版权所有。
AIM: To determine the diagnostic accuracy of a new point-of-care assay detecting anti-deamidated gliadin peptides in celiac disease (CD) patients.METHODS: One-hundred-and-twelve patients (age range: 1.8-79.2 years old) with clinical symptoms suggestive of CD and/or first-degree relatives (FDR) of CD patients (n = 66), and confirmed CD on a gluten-free diet (GFD) (n = 46), were prospectively enrolled in the study at Gastroenterology outpatient clinics for adult patients and from the Gastroenterology Consultation Ward at the Pediatric Department of the University Hospital of Geneva. Written informed consent was obtained from all subjects enrolled. The study received approval from the local ethics committee. The original CD diagnosis had been based on serum-positive IgA anti-tissue transglutaminase enzyme-linked immunosorbent assay (ELISA) (QuantaLite T, Inova Diagnostics, San Diego, CA, United States) and on biopsy results. Serum samples from all study participants were tested by the new CD lateral flow immunochromatographic assay (CD-LFIA) device, Simtomax (R) Blood Drop (Augurix SA, BioArk, Monthey, Switzerland) to detect immunoglobulin (Ig) A and IgG antibodies against de-amidated gliadin peptides. The diagnostic performance was evaluated using receiver operating characteristic curves with 95% CIs. A cut-off of 2 on the Rann colorimetric scale was used to calculate the device's sensitivity and specificity.RESULTS: CD-LFIA was highly accurate in detecting untreated celiac patients. In the group of patients with CD symptoms and/or FDR, eight new cases of CD were detected by ELISA and biopsy. All of these new cases were also correctly identified by CD-LFIA. The test yielded four false positive and four false negative results. The false positive results were all within the groups with clinical symptoms suggestive of CD and/or FDR, whereas the false negative results were all within the GFD group. The test yeld a sensitivity of 78.9% (95% CI: 54.4-93.9) and specificity of 95.7% (95% CI: 89.4-98.8), and the area under the curve reached 0.893 (95% CI: 0.798-0.988). The Kappa coefficient, calculated according to the values obtained by two readers from the same device, was of 0.96 (SE: 0.06). When the GFD patients were excluded from the analysis, the area under the curve reached 0.989 (95% CI: 0.971-1.000) and the Kappa coefficient, calculated according to the values obtained by two readers from the same device, became 0.96 (SE: 0.07). Furthermore, using the Rann scale cut-off of 2 without the GFD pa- tients, sensitivity was 100% and specificity was 93.1% (95% CI: 83.3-98.1).CONCLUSION: The new CD-LFIA rapid screening test shows good diagnostic accuracy, sensitivity and specificity, and may rule out CD in patients with CD-related symptoms. (C) 2013 Baishideng. All rights reserved.