Handley Simon A, Dote Nikko P, Wanandy Troy, Prentice Louise
Department of Pathology, 34379Royal Hobart Hospital, Hobart, TAS, Australia.
School of Medicine, Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Ann Clin Biochem. 2023 Jan;60(1):68-71. doi: 10.1177/00045632221138025. Epub 2022 Nov 12.
Pancreatic elastase-1 (PE1) can be measured to assess exocrine activity of the pancreas. A semi-automated particle-enhanced, open-channel turbidimetric immunoassay has been introduced by Bühlmann (fPELA turbo, Bühlmann Laboratories AG, Schoenenbuch, Switzerland). Published evaluation data is lacking. We therefore verified performance of the assay on the Binding Site Optilite benchtop analyser and undertook a sample comparison with the DiaSorin PE1 assay on the Liaison.
Accuracy, imprecision, lower limit of quantitation (LLoQ) and linearity of the Bühlmann fPELA turbo assay on the Binding Site Optilite analyser was ascertained. Comparison with the DiaSorin Liaison PE1 assay was also undertaken. Difference between assays was evaluated using the Wilcoxon signed-rank test and method comparison was undertaken using Spearman's rank correlation (rs), Bland-Altman and Passing-Bablok regression analyses.
The fPELA turbo assay was linear between 5 and 2500 μg/g. The LLoQ was 5 µg/g. Intra- and inter-assay imprecision was <6%. There was a good agreement (rs = 0.92) and no significant bias (5.8 µg/g, = 0.29) present between the Bühlmann fPELA turbo and DiaSorin PE1 assays.
The Bühlmann fPELA turbo assay performs well on the Binding Site Optilite analyser. Faecal elastase results are commutable between with Bühlmann fPELA turbo and DiaSorin Liaison PE1 assays.
可通过检测胰弹性蛋白酶-1（PE1）来评估胰腺的外分泌活性。Bühlmann公司（瑞士绍嫩布赫的Bühlmann Laboratories AG）推出了一种半自动颗粒增强型开放通道比浊免疫测定法（fPELA turbo）。目前缺乏已发表的评估数据。因此，我们在Binding Site Optilite台式分析仪上验证了该测定法的性能，并与DiaSorin公司在Liaison分析仪上的PE1测定法进行了样本比较。
确定了Bühlmann fPELA turbo测定法在Binding Site Optilite分析仪上的准确性、不精密度、定量下限（LLoQ）和线性。还与DiaSorin Liaison PE1测定法进行了比较。使用Wilcoxon符号秩检验评估测定法之间的差异，并使用Spearman秩相关（rs）、Bland-Altman和Passing-Bablok回归分析进行方法比较。
fPELA turbo测定法在5至2500μg/g之间呈线性。LLoQ为5μg/g。批内和批间不精密度均<6%。Bühlmann fPELA turbo测定法与DiaSorin PE1测定法之间具有良好的一致性（rs = 0.92），且无显著偏差（5.8μg/g，P = 0.29）。
Bühlmann fPELA turbo测定法在Binding Site Optilite分析仪上表现良好。粪便弹性蛋白酶检测结果在Bühlmann fPELA turbo测定法和DiaSorin Liaison PE1测定法之间具有互换性。
