Schulz Christian, Wex Thomas, Arnim Ulrike von, Malfertheiner Peter
Clin Lab. 2016 Jul 1;62(7):1249-1254. doi: 10.7754/Clin.Lab.2015.151101.
The differentiation of organic and functional intestinal diseases and monitoring of disease activity in inflammatory bowel diseases are frequent challenges in daily clinical routine. Fecal calprotectin is a noninvasive screening marker for intestinal inflammation. Its quantification by ELISA is considered to be the gold standard, but an increasing number of semiquantitative and quantitative point-of-care-tests (POCT) have been launched to optimize the duration between sample input and result.
The objective of this study was to evaluate sensitivity and specificity of two fecal calprotectin rapid test assays compared to an enzyme-linked immunosorbent assay (ELISA) as gold-standard considering the costs, time to result, and effort. For this purpose, fecal samples were collected from 68 patients with either confirmed Crohn´s disease (CD) (n = 37), confirmed ulcerative colitis (UC) (n = 21) or with confirmed IBS (n = 10) and analyzed with all three tests.
Both rapid tests analyzed in this study revealed a high sensitivity in comparison to ELISA defined as gold standard (93.0 % PreventID®, 99.9 % Quantum Blue). The negative predictive value of Quantum Blue was better than of PreventID® (99.8% vs. 84.2%). When analyzing the capacity of all applied tests to differentiate IBD from IBS, the sensitivity of all three tests was similar, but the ELISA was more specific than the POCTs. The expense of the POCT per sample is significantly above the costs per sample for the ELISA.
Both POCTs, Quantum Blue and PreventID®, provide high diagnostic accuracy and were less time consuming in clinical routine than quantification of fecal calprotectin by ELISA. This makes these tests excellent candidates for the use in clinical routine. The routine application of ELISA techniques for the quantification of fecal calprotectin levels is a valid option in laboratories or clinical departments with high quantities of samples to allow prompt follow up for patient management.
区分器质性和功能性肠道疾病以及监测炎症性肠病的疾病活动度是日常临床工作中经常面临的挑战。粪便钙卫蛋白是肠道炎症的一种非侵入性筛查标志物。通过酶联免疫吸附测定（ELISA）对其进行定量被认为是金标准，但越来越多的半定量和定量即时检验（POCT）已被推出，以优化从样本输入到结果的时间间隔。
本研究的目的是将两种粪便钙卫蛋白快速检测方法与作为金标准的酶联免疫吸附测定（ELISA）相比较，评估其敏感性和特异性，并考虑成本、出结果时间和工作量。为此，从68例确诊为克罗恩病（CD）（n = 37）、确诊为溃疡性结肠炎（UC）（n = 21）或确诊为肠易激综合征（IBS）（n = 10）的患者中收集粪便样本，并使用这三种检测方法进行分析。
与被定义为金标准的ELISA相比，本研究中分析的两种快速检测方法均显示出高敏感性（PreventID®为93.0%，Quantum Blue为99.9%）。Quantum Blue的阴性预测值优于PreventID®（99.8%对84.2%）。在分析所有应用检测方法区分炎症性肠病（IBD）和肠易激综合征（IBS）的能力时，三种检测方法的敏感性相似，但ELISA比POCT更具特异性。POCT每个样本的费用明显高于ELISA每个样本的成本。
Quantum Blue和PreventID®这两种POCT均具有较高的诊断准确性，并且在临床常规操作中比通过ELISA对粪便钙卫蛋白进行定量耗时更少。这使得这些检测方法成为临床常规应用的优秀候选方法。对于样本量较大的实验室或临床科室，采用ELISA技术常规定量粪便钙卫蛋白水平是一种有效的选择，以便能够迅速跟进患者管理。
