Department Biomedical Engineering, University of Houston, Houston, TX, USA.
Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Expert Rev Mol Diagn. 2023 Jul-Dec;23(8):729-738. doi: 10.1080/14737159.2023.2236022. Epub 2023 Jul 17.
Urinary activated leukocyte cell adhesion molecule (uALCAM) is emerging as an outstanding biomarker for active lupus nephritis (ALN). This study aims to evaluate the analytic performance of the human ALCAM ELISA as an assay method to quantify uALCAM in patients with lupus nephritis.
A commercially available human ALCAM ELISA kit was validated for its analytical performance as per Clinical & Laboratory Standards Institute guidelines.
Assaying 30 sets of serial dilutions of ALCAM exhibited an average CV of 10% and 97%-105% recovery. The assay also exhibited overall acceptable imprecision (CV < 20%) in day-to-day, site-to-site, and lot-to-lot reproducibility. The assay exhibited a reportable range from 4018 pg/ml down to 62 pg/ml with an r of 0.999 in urine, with a limit of detection of 16-45 pg/ml. Most tested chemicals did not interfere with the assay, and no diurnal variations were observed in uALCAM levels. uALCAM was stable for at least 3 months at -20°C or -80°C.
This analytic-validated uALCAM ELISA may provide physicians with an accurate and reliable tool for use in early detection of renal involvement in lupus, routine outpatient monitoring of disease activity, and long-term prognostication.
尿活化白细胞细胞黏附分子（uALCAM）作为活动性狼疮肾炎（ALN）的杰出生物标志物正在出现。本研究旨在评估人 ALCAM ELISA 的分析性能，作为定量检测狼疮肾炎患者 uALCAM 的检测方法。
根据临床和实验室标准协会的指南，对商业上可获得的人 ALCAM ELISA 试剂盒进行了分析性能验证。
检测 30 组 ALCAM 系列稀释液，平均 CV 为 10%，回收率为 97%-105%。该检测还在日间、地点间和批间重现性方面表现出总体可接受的不精密度（CV<20%）。该检测在尿液中的报告范围为 4018 pg/ml 至 62 pg/ml，r 为 0.999，检测限为 16-45 pg/ml。大多数测试化学物质不会干扰检测，并且 uALCAM 水平没有昼夜变化。uALCAM 在-20°C 或-80°C 下至少稳定 3 个月。
经分析验证的 uALCAM ELISA 可为医生提供一种准确可靠的工具，用于早期检测狼疮肾受累、常规门诊监测疾病活动度和长期预后。
