Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.
Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.
Biochem Med (Zagreb). 2017 Oct 15;27(3):030710. doi: 10.11613/BM.2017.030710.
Faecal calprotectin (FC) is a routinely used marker for identifying and monitoring children with inflammatory bowel disease (IBD). This non-invasive test is useful for screening children with gastrointestinal symptoms to avoid unnecessary invasive procedures. In this study, we validated for the first time the performance of a fully automated particle-enhanced turbidimetric immunoassay (PETIA) on the VITROS® 5600 analyzer for measurement of FC in symptomatic children and adolescents.
For performance validation of the PETIA (fCAL® turbo, Bühlmann Laboratories, Switzerland) on the VITROS® 5600 analyzer (Ortho Clinical Diagnostics, USA) limit of quantitation (LoQ), linearity, precision data and calibration curve stability were defined. Additionally, 95 faecal samples were measured using the PETIA, an enzyme-linked immunosorbent assay (ELISA; fCAL®, Bühlmann Laboratories, Switzerland) and a semi-quantitative lateral flow assay (Quantum Blue Reader®, Bühlmann Laboratories, Switzerland) for agreement evaluation.
The LoQ for calprotectin using PETIA on the VITROS® 5600 analyzer was 21 µg/g. The linearity range was 20 - 2100 µg/g and the precision study showed a total coefficient of variation (CV) between 2.3% and 8.9%. The calibration curve was stable for 4 weeks. Using the clinical samples quantifiable by PETIA, ELISA and the semi-quantitative lateral flow assay, Passing-Bablok regression analysis and Bland-Altman plots showed good agreement.
Due to good performance characteristics and agreement with established methods, the fully automated PETIA on the routine chemistry analyzer VITROS® 5600 is a new analytical option for the rapid determination of FC.
粪便钙卫蛋白（FC）是一种常用于识别和监测炎症性肠病（IBD）儿童的标志物。这种非侵入性测试可用于筛选有胃肠道症状的儿童，以避免不必要的侵入性操作。在这项研究中，我们首次验证了在 VITROS® 5600 分析仪上使用全自动颗粒增强比浊免疫测定法（PETIA）测量有症状的儿童和青少年 FC 的性能。
为了验证 VITROS® 5600 分析仪（美国 Ortho Clinical Diagnostics）上的全自动 PETIA（Bühlmann Laboratories，瑞士的 fCAL® turbo）的性能，定义了定量下限（LoQ）、线性、精密度数据和校准曲线稳定性。此外，使用 PETIA、酶联免疫吸附测定（ELISA；Bühlmann Laboratories，瑞士的 fCAL®）和半定量横向流动测定（Quantum Blue Reader®，Bühlmann Laboratories，瑞士）测量了 95 个粪便样本，用于评估一致性。
使用 VITROS® 5600 分析仪上的 PETIA，FC 的 LoQ 为 21 µg/g。线性范围为 20-2100 µg/g，精密度研究显示总变异系数（CV）在 2.3%-8.9%之间。校准曲线在 4 周内稳定。使用可通过 PETIA、ELISA 和半定量横向流动测定定量的临床样本，Passing-Bablok 回归分析和 Bland-Altman 图显示出良好的一致性。
由于具有良好的性能特征和与既定方法的一致性，在常规化学分析仪 VITROS® 5600 上使用全自动 PETIA 是快速测定 FC 的一种新的分析选择。
