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两种定量粪便钙卫蛋白快速检测法诊断活动性炎症性肠病的比较。

A comparison of diagnostic performance between two quantitative rapid fecal calprotectin assays in detecting active inflammatory bowel disease.

机构信息

Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Department of Biomedicine & Health Sciences, Graduate School, College of Medicine, The Catholic University of Korea, Seoul, Korea.

出版信息

PLoS One. 2021 Aug 12;16(8):e0255974. doi: 10.1371/journal.pone.0255974. eCollection 2021.

Abstract

BACKGROUND

Fecal calprotectin (FC) is widely used for the diagnosis and monitoring disease activity of inflammatory bowel disease (IBD). Quantitative rapid assays can be a reliable alternative to the time-consuming assay. This study aimed to evaluate and compare the diagnostic performance of two quantitative rapid FC assays (Ichroma calprotectin, and Buhlmann Quantum blue).

METHODS

A total of 192 patients were included in this study; 84 patients with IBD (67 ulcerative colitis and 17 Crohn's disease) and 108 patients with non-IBD. We compared quantitative FC levels in different disease statuses and evaluated the correlation between the FC results of the two FC kits. Diagnostic performances in predicting active IBD were evaluated in reference to different cut-off levels.

RESULTS

The FC levels in 45 patients with active IBD as defined by endoscopic score were significantly higher compared to the inactive IBD and other diseases (P<0.05). Although the two assays' results correlated (r = 0.642, P < 0.001), a significant deviation was observed (y (Buhlmannn) = -45.2 +8.9X (Ichroma)). The Diagnostic performances in predicting active IBD were comparable as area under the curve (AUC), 0.812, cut-off, 50, sensitivity, 64.4%, and specificity, 85.0% for iChroma assay and AUC, 0.826, cut-off, 100, sensitivity, 84.4%, and specificity 61.9% for Buhlmann Quantum Blue assay. FC levels using a cut-off of > 250 μg/g confirmed 85.7% (iChroma) and 64.1% (Buhlmann) of active IBD patients.

CONCLUSION

The results of the two rapid FC assays iChroma and Buhlmann showed a significant correlation, but the two test results were not interchangeable. With optimized cut-off values, rapid FC tests could be helpful in the diagnosis of IBD and differentiating active IBD from inactive or organic bowel disease.

摘要

背景

粪便钙卫蛋白(FC)广泛用于炎症性肠病(IBD)的诊断和监测疾病活动。定量快速检测可替代耗时的检测方法。本研究旨在评估和比较两种定量快速 FC 检测方法(Ichroma calprotectin 和 Buhlmann Quantum blue)的诊断性能。

方法

本研究共纳入 192 例患者;84 例 IBD 患者(67 例溃疡性结肠炎和 17 例克罗恩病)和 108 例非 IBD 患者。我们比较了不同疾病状态下的 FC 定量水平,并评估了两种 FC 试剂盒的 FC 结果之间的相关性。以不同的临界值评估预测活动 IBD 的诊断性能。

结果

根据内镜评分,45 例活动 IBD 患者的 FC 水平明显高于非活动 IBD 和其他疾病患者(P<0.05)。尽管两种检测方法的结果具有相关性(r = 0.642,P < 0.001),但观察到明显的偏差(y(Buhlmann)= -45.2 +8.9X(Ichroma))。预测活动 IBD 的诊断性能相当,曲线下面积(AUC)为 0.812,临界值为 50,敏感性为 64.4%,特异性为 85.0%,用于 iChroma 检测;AUC 为 0.826,临界值为 100,敏感性为 84.4%,特异性为 61.9%,用于 Buhlmann Quantum Blue 检测。使用 > 250 μg/g 的临界值,85.7%(iChroma)和 64.1%(Buhlmann)的活动 IBD 患者得到确认。

结论

两种快速 FC 检测方法 iChroma 和 Buhlmann 的结果具有显著相关性,但两种检测结果不能互换。通过优化临界值,快速 FC 检测有助于 IBD 的诊断,并区分活动 IBD 与非活动或器质性肠道疾病。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b9b/8360365/5f5a09c72615/pone.0255974.g001.jpg

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