Cody Ellen M, Bennett Michael R, Gulati Gaurav, Ma Qing, Altaye Mekibib, Devarajan Prasad, Brunner Hermine I
Department of Pediatric Nephrology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Kidney Int Rep. 2021 Apr 28;6(7):1949-1960. doi: 10.1016/j.ekir.2021.04.016. eCollection 2021 Jul.
Lupus nephritis (LN) confers a poor prognosis, mainly from lack of effective laboratory tests to diagnose and to evaluate therapies. We have previously shown that a set of 6 urinary biomarkers (NGAL, KIM-1, MCP-1, adiponectin, hemopexin, and ceruloplasmin) are highly sensitive and specific to identify adult and pediatric patients with active LN using renal biopsy as reference standard. Using these combinatorial urinary biomarkers, the Renal Activity Score for Lupus (RAIL) score was established, with biomarkers measured by enzyme-linked immunosorbent assay (ELISA). To enhance clinical utility of the biomarkers and RAIL, we tested the performance of RAIL with biomarkers measured by ELISA to that of biomarkers measured by the bead multiplex method, hypothesizing that the multiplex bead method would be comparable.
Spot urine samples (n = 341) of 46 patients aged 20 to 73 years with or without LN were used. Samples were assayed both by ELISA and multiplex using LUMINEX. RAIL scores and biomarker quantities were assessed for agreement with intraassay correlation coefficients and compared using Bland-Altman and regression.
Biomarker measurement by LUMINEX was successful for NGAL, KIM-1, MCP-1, and adiponectin, but not for ceruloplasmin and hemopexin. There was good agreement of the RAIL obtained from these 4 biomarkers, irrespective of assay method (intraclass correlation coefficient [ICC] = 0.78, 95% confidence interval [CI] = 0.78-0.82). The RAIL scores from 4 biomarkers further correlated with those when considering all 6 biomarkers (ICC = 0.97, 95% CI = 0.96-0.98).
The LUMINEX platform allows for the convenient and simultaneous measurement of 4 RAIL biomarkers. RAIL scores considering only these 4 biomarkers may be sufficient to accurately capture LN activity.
狼疮性肾炎（LN）预后较差，主要原因是缺乏有效的实验室检测手段来进行诊断和评估治疗效果。我们之前已经表明，一组6种尿液生物标志物（中性粒细胞明胶酶相关脂质运载蛋白[NGAL]、肾损伤分子-1[KIM-1]、单核细胞趋化蛋白-1[MCP-1]、脂联素、血红素结合蛋白和铜蓝蛋白）以肾活检作为参考标准，在识别成人和儿童活动性LN患者方面具有高度敏感性和特异性。利用这些组合尿液生物标志物，建立了狼疮性肾炎肾脏活动评分（RAIL），生物标志物通过酶联免疫吸附测定（ELISA）进行检测。为了提高生物标志物和RAIL的临床实用性，我们将通过ELISA检测生物标志物的RAIL性能与通过磁珠多重检测法检测生物标志物的RAIL性能进行了比较，假设多重磁珠法具有可比性。
使用了46例年龄在20至73岁、有或无LN的患者的随机尿样（n = 341）。样本通过ELISA和使用LUMINEX的多重检测法进行检测。评估RAIL评分和生物标志物数量的一致性，并计算批内相关系数，使用Bland-Altman法和回归分析进行比较。
通过LUMINEX检测生物标志物，对于NGAL、KIM-1、MCP-1和脂联素检测成功，但对于铜蓝蛋白和血红素结合蛋白检测不成功。无论检测方法如何，从这4种生物标志物获得的RAIL具有良好的一致性（组内相关系数[ICC] = 0.78，95%置信区间[CI] = 0.78 - 0.82）。当考虑所有6种生物标志物时，这4种生物标志物的RAIL评分与那些评分进一步相关（ICC = 0.97，95% CI = 0.96 - 0.98）。
LUMINEX平台允许方便且同时测量4种RAIL生物标志物。仅考虑这4种生物标志物的RAIL评分可能足以准确反映LN的活动情况。
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