Handley S A, Dote N P, Wanandy T, Prentice L
Biochemistry, Department of Pathology, Royal Hobart Hospital, 48 Liverpool Street, Hobart, Tasmania, 7000, Australia.
School of Medicine, University of Tasmania, Menzies Institute for Medical Research, Level 1, Medical Science 1, 17 Liverpool Street, Hobart, Tasmania, 7000, Australia.
Pract Lab Med. 2023 Jun 24;36:e00318. doi: 10.1016/j.plabm.2023.e00318. eCollection 2023 Aug.
Inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) are increasingly prevalent disorders. Faecal calprotectin is useful in the differential diagnosis of IBD from IBS and monitoring IBD activity. We verified the Bühlmann fCAL turbo faecal calprotectin assay on the Binding Site, Optilite benchtop analyser.
Accuracy, precision, lower limit of quantitation (LLoQ), and linearity of the Bühlmann fCAL turbo faecal calprotectin assay on the Binding Site, Optilite benchtop analyser were ascertained. Comparison with the Bühlmann Quantum Blue fCAL extended and DiaSorin, Liaison calprotectin assays were also undertaken. Difference between assays was evaluated using the Wilcoxon signed-rank test and method comparison was undertaken using Spearman's rank correlation (rs), difference plots and Passing-Bablok regression analyses.
The fCAL turbo assay was linear between 25 and 10,000 μg/g, and the LLoQ was 25 μg/g. Intra-, and inter-assay imprecision was <5%. There was a good agreement (rs = 0.96) and no significant bias (3%, p = 0.10) present between the fCAL turbo and Quantum Blue extended assays. Between the fCAL turbo and DiaSorin, liaison assays there was a good agreement (rs = 0.97), but a significant bias (53%, p = <0.01) was present.
The fCAL turbo assay performs well on the Binding Site, Optilite benchtop analyser. Calprotectin results are commutable between with Bühlmann fCAL turbo and Quantum Blue fCAL extended assays, but not between Bühlmann and DiaSorin calprotectin assays.
炎症性肠病（IBD）和肠易激综合征（IBS）是日益常见的疾病。粪便钙卫蛋白有助于IBD与IBS的鉴别诊断以及监测IBD的活动情况。我们在Binding Site公司的Optilite台式分析仪上验证了Bühlmann fCAL turbo粪便钙卫蛋白检测法。
确定了Bühlmann fCAL turbo粪便钙卫蛋白检测法在Binding Site公司的Optilite台式分析仪上的准确性、精密度、定量下限（LLoQ）和线性。还与Bühlmann Quantum Blue fCAL扩展检测法和DiaSorin公司的Liaison钙卫蛋白检测法进行了比较。使用Wilcoxon符号秩检验评估检测方法之间的差异，并使用Spearman秩相关（rs）、差异图和Passing-Bablok回归分析进行方法比较。
fCAL turbo检测法在25至10,000μg/g之间呈线性，LLoQ为25μg/g。批内和批间不精密度均<5%。fCAL turbo检测法与Quantum Blue扩展检测法之间具有良好的一致性（rs = 0.96），且无显著偏差（3%，p = 0.10）。fCAL turbo检测法与DiaSorin公司的Liaison检测法之间具有良好的一致性（rs = 0.97），但存在显著偏差（53%，p <0.01）。
fCAL turbo检测法在Binding Site公司的Optilite台式分析仪上表现良好。钙卫蛋白检测结果在Bühlmann fCAL turbo检测法和Quantum Blue fCAL扩展检测法之间具有互换性，但在Bühlmann检测法和DiaSorin钙卫蛋白检测法之间则不然。
