Gastroenterology Laboratory and the Division of Gastroenterology, Rabin Medical Center, Beilinson Campus, Petach Tikva, Israel
Department of Digital Medical Technologies, Holon Institute of Technology, Holon, Israel.
Ann Clin Lab Sci. 2023 Sep;53(5):784-788.
The biomarker fecal calprotectin is an efficacious tool for evaluating the level of disease activity in Crohn's and Ulcerative colitis, as well as for discriminating between inflammatory bowel disease and irritable bowel syndrome. The aim of this investigation was to appraise the analytical proficiency of a novel flow immune-chromatography assay through comparison with the established gold standard system in our laboratory.
A cohort comprising of 125 stool samples, submitted for the purpose of routine calprotectin levels analysis, underwent assessment using two distinct approaches: the Liaison XL system and the SmarTest assay, while adhering to identical cut-off criteria. The present study assessed the performance of the SmarTest assay by calculating its sensitivity, specificity, and accuracy measures.
The sensitivity, specificity, and accuracy of the SmarTest assay were found to be 97.75%, 80.56%, and 92.80%, respectively, upon comparison with the gold standard. Moreover, the Pearson correlation coefficient analysis ascertained that the linear correlation pertaining to the calprotectin levels, as identified between both assays, was statistically significant (R=0.8158, values <0.0001).
Upon comparison with the Liaison XL system, it was found that the SmarTest assay demonstrated satisfactory results in both qualitative and quantitative aspects. This novel and expedient diagnostic assay is commended for evaluating fecal calprotectin in situations where access to laboratory services may be insufficient or nonexistent, rendering it an ideal option for point-of-care or at-home testing purposes.
粪便钙卫蛋白作为一种生物标志物，可有效评估克罗恩病和溃疡性结肠炎的疾病活动程度，并可用于鉴别炎症性肠病和肠易激综合征。本研究旨在通过与本实验室建立的金标准系统进行比较，评估一种新型流动免疫层析检测法的分析性能。
对 125 份粪便样本进行研究，这些样本均用于常规钙卫蛋白水平分析，采用两种不同方法进行评估：Liaison XL 系统和 SmarTest 检测法，同时遵循相同的临界值标准。本研究通过计算敏感性、特异性和准确性来评估 SmarTest 检测法的性能。
与金标准相比，SmarTest 检测法的敏感性、特异性和准确性分别为 97.75%、80.56%和 92.80%。此外，Pearson 相关系数分析确定了两种检测法之间钙卫蛋白水平的线性相关性具有统计学意义（R=0.8158，P 值均<0.0001）。
与 Liaison XL 系统相比，SmarTest 检测法在定性和定量方面均表现出良好的结果。该新型便捷诊断检测法可用于评估粪便钙卫蛋白，在实验室服务不足或不存在的情况下，是一种理想的即时检测或家庭检测方法。
