分析评估 Abbott ARCHITECT 免疫分析仪上的自动化半乳糖凝集素-3 检测。

Analytical evaluation of the automated galectin-3 assay on the Abbott ARCHITECT immunoassay instruments.

出版信息

Clin Chem Lab Med. 2014 Jun;52(6):919-26. doi: 10.1515/cclm-2013-0942.

DOI:10.1515/cclm-2013-0942

Abstract

BACKGROUND

Galectin-3 is secreted from macrophages and binds and activates fibroblasts forming collagen. Tissue fibrosis is central to the progression of chronic heart failure (CHF). We performed a European multicentered evaluation of the analytical performance of the two-step routine and Short Turn-Around-Time (STAT) galectin-3 immunoassay on the ARCHITECT i1000SR, i2000SR, and i4000SR (Abbott Laboratories).

METHODS

We evaluated the assay precision and dilution linearity for both routine and STAT assays and compared serum and plasma, and fresh vs. frozen samples. The reference interval and biological variability were also assessed. Measurable samples were compared between ARCHITECT instruments and between the routine and STAT assays and also to a galectin-3 ELISA (BG Medicine).

RESULTS

The total assay coefficient of variation (CV%) was 2.3%-6.2% and 1.7%-7.4% for the routine and STAT assays, respectively. Both assays demonstrated linearity up to 120 ng/mL. Galectin-3 concentrations were higher in plasma samples than in serum samples and correlated well between fresh and frozen samples (R=0.997), between the routine and STAT assays, between the ARCHITECT i1000 and i2000 instruments and with the galectin-3 ELISA. The reference interval on 627 apparently healthy individuals (53% male) yielded upper 95th and 97.5th percentiles of 25.2 and 28.4 ng/mL, respectively. Values were significantly lower in subjects younger than 50 years.

CONCLUSIONS

The galectin-3 routine and STAT assays on the Abbott ARCHITECT instruments demonstrated good analytical performance. Further clinical studies are required to demonstrate the diagnostic and prognostic potential of this novel marker in patients with CHF.

摘要

背景

半乳糖凝集素-3 由巨噬细胞分泌，与成纤维细胞结合并激活，形成胶原蛋白。组织纤维化是慢性心力衰竭（CHF）进展的核心。我们在欧洲进行了一项多中心评估，评估两步常规和短周转时间（STAT）半乳糖凝集素-3 免疫分析在 ARCHITECT i1000SR、i2000SR 和 i4000SR（雅培实验室）上的分析性能。

方法

我们评估了常规和 STAT 测定的测定精密度和稀释线性，并比较了血清和血浆、新鲜样本和冷冻样本。还评估了参考区间和生物学变异性。比较了 ARCHITECT 仪器之间、常规和 STAT 测定之间以及半乳糖凝集素-3 ELISA（BG Medicine）之间可测量的样本。

结果

总测定变异系数（CV%）分别为常规和 STAT 测定的 2.3%-6.2%和 1.7%-7.4%。两种测定均显示线性至 120 ng/mL。血浆样本中的半乳糖凝集素-3 浓度高于血清样本，并且在新鲜和冷冻样本之间相关性良好（R=0.997），在常规和 STAT 测定之间，在 ARCHITECT i1000 和 i2000 仪器之间以及与半乳糖凝集素-3 ELISA 之间。627 名显然健康个体（53%为男性）的参考区间上 95%和 97.5%的上限分别为 25.2 和 28.4ng/mL。年龄小于 50 岁的个体值明显较低。