Clin Lab. 2020 Apr 1;66(4). doi: 10.7754/Clin.Lab.2020.200126.
Fecal calprotectin is an excellent biomarker for distinguishing inflammatory bowel disease from irritable bowel syndrome and for evaluation of disease activity in Crohn's disease and ulcerative colitis. The aim of this work was to evaluate the analytical performance of a new flow immune chromatography assay by comparing it to our standardized laboratory gold standard system.
A total of 100 stool samples sent for routine calprotectin level measurements were analyzed by the Liaison XL system and the QuantOn Cal assay simultaneously using the same cutoff values for both assays. Performance of the QuantOn Cal assay was assessed by calculating sensitivity, specificity, and accuracy.
Compared with the gold standard, the sensitivity, specificity, and accuracy of the QuantOn Cal assay were 98.7%, 76.2%, and 94.0%, respectively. Furthermore, linear correlation of calprotectin levels between the two assays were found to be significant by Pearson's correlation coefficient test (r = 0.82, p-values < 0.0001).
The QuantOn Cal assay demonstrated good performance, both qualitative and quantitative when compared to the Liaison XL system. This novel and rapid assay is well suited for measuring fecal calprotectin as a point of care or home-based assay when laboratory services are limited or not available.
粪便钙卫蛋白是鉴别炎症性肠病与肠易激综合征、评估克罗恩病和溃疡性结肠炎疾病活动度的优秀生物标志物。本研究旨在通过与我们的标准化实验室金标准系统进行比较，评估一种新的流动免疫色谱测定法的分析性能。
采用 Liaison XL 系统和 QuantOn Cal 检测试剂盒同时对 100 例送检的常规粪便钙卫蛋白水平的粪便标本进行分析，两个检测方法均使用相同的临界值。通过计算灵敏度、特异性和准确度来评估 QuantOn Cal 检测试剂盒的性能。
与金标准相比，QuantOn Cal 检测试剂盒的灵敏度、特异性和准确度分别为 98.7%、76.2%和 94.0%。此外，Pearson 相关系数检验显示两种检测方法之间钙卫蛋白水平的线性相关性显著（r=0.82，p 值均<0.0001）。
与 Liaison XL 系统相比，QuantOn Cal 检测试剂盒在定性和定量方面均表现出良好的性能。该新型快速检测试剂盒非常适合在实验室服务有限或不可用时进行床边或家庭检测，以测量粪便钙卫蛋白。
