Vicente-Steijn R, Jansen J M, Bisheshar R, Haagen I-A
Laboratory of Hematology and Clinical Chemistry, OLVG Oost, Amsterdam, the Netherlands.
Department of Gastroenterology and Hepatology, OLVG Oost, Amsterdam, the Netherlands.
Pract Lab Med. 2020 Jun 24;21:e00175. doi: 10.1016/j.plabm.2020.e00175. eCollection 2020 Aug.
Distinction between inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) based on clinical symptoms is often difficult. In this study we assessed the performance of the fully-automated calprotectin immunoassay from DiaSorin in IBD diagnosis and follow-up and compared it to the EliA calprotectin 2 immunoassay.
and Methods: The calprotectin immunoassay from DiaSorin run on the LIAISONXL was analytically and clinically validated and compared to the EliA calprotectin 2 immunoassay from Thermo Fisher Scientific run on the ImmunoCAP250. Five patient groups were measured (n = 303): IBD: ulcerative colitis (UC) and Crohn's disease (CD); non-IBD: IBS, other gastrointestinal diseases and controls (healthy patients with no gastrointestinal disease).
The calprotectin immunoassay of DiaSorin showed good analytical performance with frozen samples. The presence of blood in the stool can interfere with the measurement of calprotectin. Patients suffering from IBD (UC or CD) showed significant higher concentrations of fecal calprotectin compared to controls (UC:710 ± 921 mg/kg; CD:967 ± 1243 mg/kg; controls:11±8 mg/kg) using DiaSorin's immunoassay. The remaining non-IBD groups showed no significant difference compared to controls. Follow-up patients (n = 9) showed a significant decrease in fecal calprotectin after treatment. At 50 mg/kg cut-off value, the negative predictive value for DiaSorin's immunoassay was 96% and the positive predictive value 83% (sensitivity of 95% and specificity of 86%).
The lack of standardization contributes to the numerical differences between the two methods, but the qualitative conclusions do not differ. DiaSorin's calprotectin immunoassay can be used both to distinguish between IBD and non-IBD patients as well as for follow-up of IBD patients.
基于临床症状区分炎症性肠病（IBD）和肠易激综合征（IBS）往往很困难。在本研究中，我们评估了DiaSorin全自动钙卫蛋白免疫测定法在IBD诊断和随访中的性能，并将其与EliA钙卫蛋白2免疫测定法进行比较。
在LIAISON XL上运行的DiaSorin钙卫蛋白免疫测定法经过了分析和临床验证，并与在ImmunoCAP 250上运行的赛默飞世尔科技公司的EliA钙卫蛋白2免疫测定法进行比较。对五组患者（n = 303）进行了检测：IBD：溃疡性结肠炎（UC）和克罗恩病（CD）；非IBD：IBS、其他胃肠道疾病和对照组（无胃肠道疾病的健康患者）。
DiaSorin的钙卫蛋白免疫测定法对冷冻样本显示出良好的分析性能。粪便中存在血液会干扰钙卫蛋白的测量。使用DiaSorin免疫测定法，IBD（UC或CD）患者的粪便钙卫蛋白浓度显著高于对照组（UC：710±921mg/kg；CD：967±1243mg/kg；对照组：11±8mg/kg）。其余非IBD组与对照组相比无显著差异。随访患者（n = 9）治疗后粪便钙卫蛋白显著下降。在50mg/kg的临界值时，DiaSorin免疫测定法的阴性预测值为96%，阳性预测值为83%（敏感性为95%，特异性为86%）。
缺乏标准化导致了两种方法之间的数值差异，但定性结论并无不同。DiaSorin的钙卫蛋白免疫测定法可用于区分IBD和非IBD患者，也可用于IBD患者的随访。
