Vinding Kristoffer Kofod, Elsberg Henriette, Thorkilgaard Tine, Belard Erika, Pedersen Natalia, Elkjaer Margarita, Marker Dorte, Carlsen Katrine, Burisch Johan, Munkholm Pia
*Gastrounit, Medical Section, Herlev University Hospital, Herlev, Denmark; †Department of Gastroenterology, Slagelse University Hospital, Slagelse, Denmark; ‡Gastrounit, North Zealand Hospital, University of Copenhagen, Frederikssund, Denmark; §Department of Pediatrics, Hvidovre University Hospital, Hvidovre, Denmark; and ‖Gastrounit, Medical section, Hvidovre University Hospital, Hvidovre, Denmark.
Inflamm Bowel Dis. 2016 Feb;22(2):336-44. doi: 10.1097/MIB.0000000000000619.
Fecal calprotectin is a reliable noninvasive marker for intestinal inflammation usable for monitoring patients with inflammatory bowel disease. Tests are usually performed by enzyme-linked immunosorbent assay (ELISA), which is time consuming and delays results, thus limiting its use in clinical practice. Our aim was to evaluate CalproSmart, a new rapid test for fecal calprotectin performed by patients themselves at home, and compare it to gold standard ELISA.
A total of 221 patients with inflammatory bowel disease (115 ulcerative colitis and 106 Crohn's disease) were included. The CalproSmart test involves extraction of feces, application to the lateral flow device, and taking a picture with a smartphone after 10 minutes of incubation. Results appear on the screen within seconds. Patients were instructed at inclusion and had a video guide of the procedure as support. When using CalproSmart at home, patients also sent in 2 fecal samples to be analyzed by ELISA.
Totally, 894 fecal calprotectin results were obtained by ELISA, and 632 of them from CalproSmart. The correlation coefficient was 0.685, higher for academics than nonacademics (0.768 versus 0.637; P = 0.0037). The intra-assay and interassay coefficients of variation of the CalproSmart test were 4.42% and 12.49%, respectively. The sensitivity, specificity, positive predictive value, and negative predictive value were 82%, 85%, 47%, and 97%, respectively, with an optimal cutoff at 150 μg/g.
The CalproSmart test performed by patients with inflammatory bowel disease for fast assessment of gut inflammation seems a reliable alternative to ELISA and presents a new way of monitoring patients by eHealth.
粪便钙卫蛋白是用于监测炎症性肠病患者的一种可靠的肠道炎症非侵入性标志物。检测通常通过酶联免疫吸附测定（ELISA）进行，该方法耗时且结果延迟，因此限制了其在临床实践中的应用。我们的目的是评估CalproSmart，一种由患者在家自行操作的新型粪便钙卫蛋白快速检测方法，并将其与金标准ELISA进行比较。
共纳入221例炎症性肠病患者（115例溃疡性结肠炎和106例克罗恩病）。CalproSmart检测包括粪便提取、应用于侧向流动装置，并在孵育10分钟后用智能手机拍照。结果在几秒钟内出现在屏幕上。患者在纳入时接受指导，并以操作视频作为支持。在家使用CalproSmart时，患者还送检2份粪便样本用于ELISA分析。
ELISA共获得894份粪便钙卫蛋白检测结果，CalproSmart获得632份。相关系数为0.685，学者组高于非学者组（0.768对0.637；P = 0.0037）。CalproSmart检测的批内和批间变异系数分别为4.42%和12.49%。灵敏度、特异度、阳性预测值和阴性预测值分别为82%、85%、47%和97%，最佳临界值为150μg/g。
炎症性肠病患者使用CalproSmart检测快速评估肠道炎症似乎是ELISA的可靠替代方法，并为通过电子健康监测患者提供了一种新途径。
