Sataranatarajan Kavithalakshmi, Adhikari Shishir, Nguyen Ngoc, Narasimhan Madhusudhanan, Balani Jyoti, Muthukumar Alagarraju
Department of Pathology, University of Texas Southwestern Medical Center, Dallas, TX 75235, USA.
Core Laboratory, Clements University Hospital, University of Texas Southwestern Medical Center, Dallas, TX 75235, USA.
Diagnostics (Basel). 2024 Aug 11;14(16):1744. doi: 10.3390/diagnostics14161744.
Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the gastrointestinal (GI) tract. Fecal calprotectin (fCAL) is a noninvasive laboratory test used in the diagnosis and monitoring of IBDs such as Crohn's disease and ulcerative colitis. The fCAL send-out test that our facility has been offering so far uses an ELISA-based method. In the current study, we sought to validate the performance of a Buhlmann fCAL turbo assay in an automated Abbott Alinity C analyzer (AFCAL) in our core laboratory. Five-day imprecision studies showed good performance for both within-run (5.3%) and between-day (2.5%) measurements. The reportable range was verified as 30-20,000 µg/g. Deming regression and Bland-Altman analysis indicated a strong correlation of r = 0.99 with a low, acceptable bias of 1.8% for AFCAL relative to the predicate Buhlmann fCAL ELISA results. AFCAL's clinical performance was determined retrospectively in 62 patients with ICD codes for IBD. Overall, the implementation of AFCAL in our routine clinical testing has improved our turnaround time, reduced the cost per test, and significantly increased our clinician satisfaction.
炎症性肠病（IBD）的特征是胃肠道（GI）的慢性炎症。粪便钙卫蛋白（fCAL）是一种用于诊断和监测克罗恩病和溃疡性结肠炎等IBD的非侵入性实验室检测方法。我们机构目前提供的fCAL外送检测采用基于酶联免疫吸附测定（ELISA）的方法。在本研究中，我们试图在核心实验室的自动化雅培Alinity C分析仪（AFCAL）中验证Buhlmann fCAL快速检测法的性能。为期五天的不精密度研究表明，批内（5.3%）和批间（2.5%）测量均表现良好。可报告范围经核实为30 - 20,000 µg/g。Deming回归分析和Bland-Altman分析表明，相对于作为参照的Buhlmann fCAL ELISA结果，AFCAL的相关系数r = 0.99，偏差低且可接受，为1.8%。我们对62例具有IBD国际疾病分类代码的患者进行回顾性分析，以确定AFCAL的临床性能。总体而言，在我们的常规临床检测中采用AFCAL缩短了周转时间，降低了每次检测的成本，并显著提高了临床医生的满意度。
