用于同时测量粪便中钙卫蛋白和血红蛋白的新型乳胶凝集比浊免疫分析系统。
The novel latex agglutination turbidimetric immunoassay system for simultaneous measurements of calprotectin and hemoglobin in feces.
作者信息
Hiraoka Sakiko, Takashima Shiho, Inokuchi Toshihiro, Nakarai Asuka, Takahara Masahiro, Harada Keita, Seki Yasuhiro, Watanabe Katsunori, Kato Jun, Okada Hiroyuki
机构信息
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Department of Endoscopy, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
出版信息
Intest Res. 2019 Apr;17(2):202-209. doi: 10.5217/ir.2018.00086. Epub 2018 Dec 14.
BACKGROUND/AIMS: Fecal calprotectin (Fcal) as well as the fecal immunochemical test (FIT) are useful biomarkers for detecting activity and mucosal healing in inflammatory bowel diseases. Here, we report the performance of simultaneous measurements of Fcal and FIT for ulcerative colitis (UC) patients using the newly-developed latex agglutination turbidimetric immunoassay (LATIA) system.
METHODS
Fcal and hemoglobin were measured by the LATIA system in 152 UC patients who underwent colonoscopy. Fcal was also quantified with a conventional enzyme-linked immunosorbent assay (ELISA). Fecal markers were evaluated in conjunction with the mucosal status of UC, which was assessed via the Mayo endoscopic subscore (MES) classification.
RESULTS
The LATIA system could quantify calprotectin and hemoglobin simultaneously with the same fecal samples within 10 minutes. The values of the Fcal-LATIA closely correlated with those of the Fcal-ELISA (Spearman rank correlation coefficient, r=0.84; P<0.0001). The values of Fcal for each assay and the FIT all significantly correlated with the MESs (Spearman rank correlation coefficient, Fcal-LATIA: r=0.58, Fcal-ELISA: r=0.55, and FIT: r=0.72). The mucosal healing predictability (determined by an MES of 0 alone) of the Fcal-LATIA, Fcal-ELISA, and FIT-LATIA with the cutoffs determined by receiver operating characteristic curve analysis was 0.79, 0.78, and 0.92 for sensitivity, respectively, and 0.78, 0.69, and 0.73 for specificity, respectively.
CONCLUSIONS
The performance of the novel Fcal-LATIA was equivalent to that of the conventional Fcal assay. Simultaneous measurements with FITs would promote the clinical relevance of fecal biomarkers in UC.
背景/目的:粪便钙卫蛋白(Fcal)以及粪便免疫化学检测(FIT)是用于检测炎症性肠病活动度和黏膜愈合的有用生物标志物。在此,我们报告使用新开发的乳胶凝集比浊免疫分析(LATIA)系统同时检测溃疡性结肠炎(UC)患者Fcal和FIT的性能。
方法
采用LATIA系统对152例接受结肠镜检查的UC患者检测Fcal和血红蛋白。Fcal也采用传统的酶联免疫吸附测定(ELISA)进行定量。结合UC的黏膜状态评估粪便标志物,UC的黏膜状态通过梅奥内镜亚评分(MES)分类进行评估。
结果
LATIA系统可在10分钟内对同一粪便样本同时定量钙卫蛋白和血红蛋白。Fcal-LATIA的值与Fcal-ELISA的值密切相关(Spearman等级相关系数,r = 0.84;P < 0.0001)。每种检测方法的Fcal值和FIT值均与MES显著相关(Spearman等级相关系数,Fcal-LATIA:r = 0.58,Fcal-ELISA:r = 0.55,FIT:r = 0.72)。通过受试者工作特征曲线分析确定临界值后,Fcal-LATIA、Fcal-ELISA和FIT-LATIA对黏膜愈合的预测能力(仅由MES为0确定),敏感性分别为0.79、0.78和0.92,特异性分别为0.78、0.69和0.73。
结论
新型Fcal-LATIA的性能与传统Fcal检测相当。与FIT同时检测将提高粪便生物标志物在UC中的临床应用价值。