Oyaert Matthijs, Boel An, Jacobs Julie, Van den Bremt Stefanie, De Sloovere Maxime, Vanpoucke Hilde, Van Hoovels Lieve
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Clin Chem Lab Med. 2017 Aug 28;55(10):1564-1573. doi: 10.1515/cclm-2016-1012.
We evaluated the analytical performance of six different faecal calprotectin immunoassays together with their diagnostic accuracy in the discrimination between functional and organic bowel disorders.
The faecal samples were obtained from inflammatory bowel disease patients (n=27) at the time of diagnosis [Crohn's disease (n=15), colitis ulcerosa (n=12)], gastroenterologic disease control patients (n=52) and rheumatologic disease control patients (n=26). All individuals included in the study underwent a concurrent ileocolonoscopy. Analytical performance (imprecision, accuracy, carry-over, correlation and agreement) and diagnostic accuracy (sensitivity, specificity, likelihood ratios) of the different assays were evaluated.
All methods demonstrated good analytical performance, but within-run and total imprecision varied depending on the assay methodology used. Using Passing Bablok and Bland-Altman analyses, low quantitative agreement was observed between the assays. All assays showed excellent diagnostic accuracy, with areas under the receiver operating characteristic curves (ROC) ranging from 0.974 to 0.998. The AUCs were not significantly different between assays (p>0.05). Diagnostic sensitivity at the cut-off at a fixed specificity of 75% ranged from 95.2% to 100%. Introduction of multiple result intervals increased the clinical interpretation of all the assays.
Analytical and diagnostic performance of the evaluated faecal calprotectin assays is good, but numerical values differ substantially between the assays necessitating the use of different clinical cut-offs. Introduction of multiple result intervals aids in clinical decision-making.
我们评估了六种不同的粪便钙卫蛋白免疫测定法的分析性能及其在区分功能性和器质性肠道疾病中的诊断准确性。
粪便样本取自炎症性肠病患者（n = 27）确诊时[克罗恩病（n = 15），溃疡性结肠炎（n = 12）]、胃肠病对照患者（n = 52）和风湿病对照患者（n = 26）。纳入研究的所有个体均同时接受了回结肠镜检查。评估了不同测定法的分析性能（不精密度、准确性、携带污染、相关性和一致性）和诊断准确性（敏感性、特异性、似然比）。
所有方法均显示出良好的分析性能，但批内和总不精密度因所使用的测定方法而异。使用Passing Bablok分析和Bland-Altman分析，各测定法之间观察到低定量一致性。所有测定法均显示出优异的诊断准确性，受试者工作特征曲线（ROC）下面积范围为0.974至0.998。各测定法之间的AUC无显著差异（p>0.05）。在固定特异性为75%时的诊断敏感性范围为95.2%至100%。引入多个结果区间增加了所有测定法的临床解读。
所评估的粪便钙卫蛋白测定法的分析和诊断性能良好，但各测定法的数值差异很大，因此需要使用不同的临床临界值。引入多个结果区间有助于临床决策。
