Garnett Emily, Pagaduan Jayson, Rajapakshe Deepthi, Tam Estella, Kellermayer Richard, Devaraj Sridevi
Baylor College of Medicine, Houston, TX, USA.
Texas Children's Hospital, Houston, TX, USA.
Pract Lab Med. 2020 Oct 17;22:e00178. doi: 10.1016/j.plabm.2020.e00178. eCollection 2020 Nov.
Inflammatory bowel disease (IBD) is an increasingly prevalent disorder marked by chronic intestinal inflammation. Fecal calprotectin has emerged as a useful biomarker for differential diagnostics and monitoring IBD activity. We validated the newly FDA-approved fCal Turbo fecal calprotectin assay in our pediatric hospital.
The performance of the fCal Turbo assay was assessed on the Vitros 5600 analyzer (Ortho Clinical Diagnostics, USA), including limit of quantitation, linearity, precision, and interference studies. Method comparison was performed with 20 fecal samples with the Buhlmann fCal ELISA, and reference range verification was performed with 33 fecal samples.
The fCal Turbo assay on the Vitros 5600 was linear between 33.1 and 14,182.5 μg/g, with dilution studies extending the range to 33.1-22,000 μg/g, Reproducibility of the assay met acceptability criteria, with intra-assay CV of 0.3-3.2% and inter-assay CV of 5.2-8.9%. Interference studies identified acceptable thresholds for protein, bilirubin, and lipids. We verified a reference range of 33.1-60 μg/g in our patient population. Deming regression identified acceptable correlation with minor positive bias (2.7%) between the fCal Turbo and fCal ELISA methods.
The fCal Turbo assay performs well on the Vitros 5600 analyzer in our patient population, with the assay being easy to use in our routine chemistry workflow. We anticipate that the fCal Turbo assay will be useful as a rapid screening method for differential diagnostics and disease monitoring of IBD in our patient population.
炎症性肠病（IBD）是一种日益普遍的以慢性肠道炎症为特征的疾病。粪便钙卫蛋白已成为用于IBD鉴别诊断和监测疾病活动的有用生物标志物。我们在我院儿科对新获得美国食品药品监督管理局（FDA）批准的fCal Turbo粪便钙卫蛋白检测法进行了验证。
在Vitros 5600分析仪（美国奥森多临床诊断公司）上评估fCal Turbo检测法的性能，包括定量限、线性、精密度和干扰研究。用Buhlmann fCal ELISA法对20份粪便样本进行方法比较，并对33份粪便样本进行参考范围验证。
在Vitros 5600上进行的fCal Turbo检测法在33.1至14,182.5μg/g之间呈线性，稀释研究将范围扩展至33.1 - 22,000μg/g。该检测法的重现性符合可接受标准，批内变异系数为0.3 - 3.2%，批间变异系数为5.2 - 8.9%。干扰研究确定了蛋白质、胆红素和脂质的可接受阈值。我们在我院患者群体中验证了33.1 - 60μg/g的参考范围。Deming回归分析表明，fCal Turbo和fCal ELISA方法之间存在可接受的相关性，有轻微正偏差（2.7%）。
fCal Turbo检测法在我院患者群体的Vitros 5600分析仪上表现良好，且该检测法易于应用于我们的常规化学检测流程。我们预计fCal Turbo检测法将作为一种快速筛查方法，用于我院患者群体中IBD的鉴别诊断和疾病监测。
