Mandic-Havelka Aleksandra, Nilsen Tom, Sunde Kathrin, Norell Maria, Hansson Lars O, Larsson Anders
Clin Lab. 2017 May 1;63(5):907-913. doi: 10.7754/Clin.Lab.2016.161032.
Fecal calprotectin assays are widely used in diagnosis and monitoring of inflammatory bowel disease (IBD) in patients with suspected IBD. The most frequently used technique is ELISA and microtiter plates. Turbidimetric assays for analysis of fecal calprotectin can significantly reduce turnaround time. Many laboratories may be reluctant to run fecal samples on their large chemistry analyzers. The aim of this study was to evaluate fecal calprotectin particle enhanced turbidimetric immunoassay (PETIA) on smaller chemistry analyzers that could be dedicated for fecal samples.
The BÜHLMANN fCAL® turbo assay was validated on two table top chemistry analyzers, Mindray BS-200E and cobas® c111.
The assay was linear in the range between 20 and 1,900 µg/g with a limit of quantification around 20 µg/g on both instruments. The total coefficient of variation was < 7% in the range between 50 and 1,300 µg/g on both instruments. No antigen excess hook effect was observed up to 18,000 µg/g on the Mindray BS-200E and up to 20,000 µg/g on cobas® c111. The BÜHLMANN fCAL® turbo assay showed a high correlation with the BÜHLMANN fCAL® ELISA.
Running the BÜHLMANN fCAL® turbo on Mindray BS-200E or cobas® c111 chemistry analyzers can provide rapid test results without exposing large routine chemistry analyzers to stool samples.
粪便钙卫蛋白检测广泛应用于疑似炎症性肠病(IBD)患者的IBD诊断和监测。最常用的技术是酶联免疫吸附测定(ELISA)和微量滴定板。用于分析粪便钙卫蛋白的比浊法可显著缩短周转时间。许多实验室可能不愿意在其大型化学分析仪上检测粪便样本。本研究的目的是评估在可专门用于粪便样本检测的小型化学分析仪上进行粪便钙卫蛋白颗粒增强比浊免疫测定(PETIA)的效果。
在两台台式化学分析仪迈瑞BS - 200E和cobas® c111上对BÜHLMANN fCAL® turbo检测法进行验证。
在两台仪器上,该检测法在20至1900 µg/g范围内呈线性,定量限约为20 µg/g。在两台仪器上浓度范围为50至1300 µg/g时,总变异系数均<7%。在迈瑞BS - 200E上,高达18000 µg/g、在cobas® c111上高达20000 µg/g时均未观察到抗原过量钩状效应。BÜHLMANN fCAL® turbo检测法与BÜHLMANN fCAL® ELISA显示出高度相关性。
在迈瑞BS - 200E或cobas® c111化学分析仪上运行BÜHLMANN fCAL® turbo检测法可提供快速检测结果,同时避免大型常规化学分析仪接触粪便样本。