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Validation of rapid fecal calprotectin assay using particle enhanced turbidimetric immunoassay for inflammatory bowel disease
Scientific Reports ( IF 3.8 ) Pub Date : 2024-01-18 , DOI: 10.1038/s41598-024-51580-z
Akihiko Oka 1 , Kousaku Kawashima 1, 2, 3 , Kenichi Kishimoto 1 , Satoshi Kotani 1 , Mai Fukunaga 1 , Nobuhiko Fukuba 1 , Yoshiyuki Mishima 1 , Naoki Oshima 1 , Norihisa Ishimura 1 , Muyiwa Awoniyi 4 , Shunji Ishihara 1, 2
Affiliation  

Fecal calprotectin (FC) is a promising biomarker for diagnosis and treatment of inflammatory bowel disease, ulcerative colitis (UC), and Crohn’s disease. An enzyme immunoassay (EIA) is widely used for FC detection, though the considerable lag time, up to several days, causes clinical management delay. This study was performed to examine the new rapid kit fCAL-turbo, which is based on a particle-enhanced turbidimetric immunoassay (15 min), by comparing FC values with other EIAs (EliA, PhiCal, Bühlmann) and endoscopic scores. Using 94 samples, fCAL-turbo showed strong significant positive correlations with the other kits (Spearman’s r = 0.9178–0.9886). Of 74 UC patients, 69 underwent an endoscopy and fCAL-turbo reflected endoscopic activity with a moderate correlation with Mayo endoscopic subscore (MES) (r = 0.6945, others r = 0.6682–0.7013). Receiver operating characteristic analyses based on MES 0 versus 1–3 showed a similar efficacy as compared to the other kits (cut-off and area under the curve: 89.70 µg/g and 0.8592, respectively, others 62.35–138.4 µg/g and 0.8280–0.8611, respectively). Furthermore, multiple regression analysis confirmed that fCAL-turbo results significantly contributed to prediction of MES 0 with a higher t-value as compared to the other biomarkers. fCAL-turbo showed strong correlations with the other kits and also demonstrated excellent performance for predicting endoscopic remission of UC.



中文翻译:


使用颗粒增强比浊免疫分析法验证快速粪便钙卫蛋白测定对炎症性肠病的影响



粪便钙卫蛋白 (FC) 是一种有前景的生物标志物,可用于诊断和治疗炎症性肠病、溃疡性结肠炎 (UC) 和克罗恩病。酶免疫分析 (EIA) 广泛用于 FC 检测,但其滞后时间较长(长达数天),导致临床管理延迟。本研究旨在通过将 FC 值与其他 EIA(EliA、PhiCal、Bühlmann)和内窥镜评分进行比较,来检查新型快速试剂盒 fCAL-turbo,该试剂盒基于粒子增强比浊免疫测定(15 分钟)。使用 94 个样本,fCAL-turbo 与其他试剂盒显示出强烈的显着正相关性(Spearman's r = 0.9178–0.9886)。在 74 名 UC 患者中,69 名接受了内窥镜检查,fCAL-turbo 反映了内窥镜活动,与 Mayo 内窥镜评分 (MES) 具有中度相关性(r = 0.6945,其他 r = 0.6682–0.7013)。基于 MES 0 与 1-3 的受试者操作特征分析显示与其他试剂盒相似的功效(截止值和曲线下面积:分别为 89.70 µg/g 和 0.8592,其他试剂盒为 62.35–138.4 µg/g 和 0.8280 –0.8611,分别)。此外,多元回归分析证实,与其他生物标志物相比,fCAL-turbo 结果显着有助于预测 MES 0,具有更高的 t 值。 fCAL-turbo 与其他试剂盒显示出很强的相关性,并且在预测 UC 内镜缓解方面也表现出出色的性能。

更新日期:2024-01-21
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