Analytical validation of urine ALCAM ELISA as a test for lupus nephritis.

IF 3.9 3区医学 Q1 PATHOLOGY Expert Review of Molecular Diagnostics Pub Date : 2023-07-01 Epub Date: 2023-07-17 DOI:10.1080/14737159.2023.2236022

Rongwei Lei, Nga Thai, Yaxi Li, Michelle Petri, Chandra Mohan

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Abstract

Objectives: 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.

Methods: A commercially available human ALCAM ELISA kit was validated for its analytical performance as per Clinical & Laboratory Standards Institute guidelines.

Results: 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 r² 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.

Conclusion: 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.

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尿ALCAM-ELISA检测狼疮性肾炎的分析验证。

目的：尿活化白细胞粘附分子（uALCAM）是活动性狼疮肾炎（ALN）的一种重要生物标志物。本研究旨在评估人ALCAM ELISA作为一种定量狼疮性肾炎患者uALCAM的检测方法的分析性能。方法：根据临床与实验室标准研究所的指导方针，对市售的人ALCAM ELISA试剂盒的分析性能进行验证。结果：测定30组ALCAM系列稀释液的平均CV为10%，回收率为97%-105%。该测定也显示出总体可接受的不精确性（CV 尿液中0.999的2，检测限为16-45 pg/ml。大多数测试的化学物质都不会干扰测定，也没有观察到uALCAM水平的昼夜变化。uALCAM稳定至少3年在-20°C或-80°C下的几个月。结论：该分析验证的uALCAM-ELISA可以为医生提供一种准确可靠的工具，用于早期检测狼疮的肾脏受累、常规门诊疾病活动监测和长期预后。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Molecular Diagnostics 医学-病理学

CiteScore

6.60

自引率

0.00%

发文量

审稿时长

1 months

期刊介绍： Expert Review of Molecular Diagnostics (ISSN 1473-7159) publishes expert reviews of the latest advancements in the field of molecular diagnostics including the detection and monitoring of the molecular causes of disease that are being translated into groundbreaking diagnostic and prognostic technologies to be used in the clinical diagnostic setting. Each issue of Expert Review of Molecular Diagnostics contains leading reviews on current and emerging topics relating to molecular diagnostics, subject to a rigorous peer review process; editorials discussing contentious issues in the field; diagnostic profiles featuring independent, expert evaluations of diagnostic tests; meeting reports of recent molecular diagnostics conferences and key paper evaluations featuring assessments of significant, recently published articles from specialists in molecular diagnostic therapy. Expert Review of Molecular Diagnostics provides the forum for reporting the critical advances being made in this ever-expanding field, as well as the major challenges ahead in their clinical implementation. The journal delivers this information in concise, at-a-glance article formats: invaluable to a time-constrained community.