Background: Circulating galectin-3 (Gal-3) levels have been indicated as a promising diagnostic, prognostic, and therapeutic target in breast cancer patients. Specifically, serum galectin-3 levels are traditionally measured using manual Enzyme-Linked Immunosorbent Assay (ELISA), but recent automated methods, such as Simple Plex assay by ProteinSimple™ run on an Ella instrument, have shown promising evidence of being more efficient and less error-prone than manual methods. This paper aims to assess whether there are differences in serum galectin-3 measurements between manual and automated ELISA methods.Methods: Serum galectin-3 levels were initially analyzed from one hundred and fifteen breast cancer samples using both manual ELISA and the Ella instrument. Following coefficient of variation (CV) and outlier analysis, ninety-five samples were analyzed further with JMP statistical software to perform Shapiro-Wilk, Spearman’s correlation, Wilcoxon signed-rank, and regression analyses.Results: The Ella instrument resulted in significantly lower CV values, confirming that it is more precise and reliable than manual ELISA methods. There was a moderate correlation between ELISA and Ella measurements (r = 0.49,p< 0.0001), but a Wilcoxon signed-rank test revealed that serum gaelectin-3 measurements obtained with the Ella instrument were significantly lower compared to those obtained with manual ELISA, with a mean difference of −5.19 ng/mL (p< 0.0001). Regression analysis showed a significant increase in the difference between manual ELISA and Ella measurements as serum galectin-3 levels increase (p< 0.0001). This difference in measurements between manual and automated ELISA techniques remained consistent when analyses were performed within each breast cancer stage, immunophenotype, and histology.Conclusions: While the Ella instrument is a fast and reliable tool, the discrepancies between manual ELISA and the Ella instrument in quantifying serum galectin-3 levels are important to consider prior to widespread use.
背景：循环半乳糖凝集素-3（Gal-3）水平已被证实是乳腺癌患者具有潜力的诊断、预后及治疗靶点。传统上，血清半乳糖凝集素-3水平通常通过手工酶联免疫吸附试验（ELISA）进行测定，但近期自动化检测方法（如ProteinSimple™开发的Simple Plex检测法，通过Ella仪器运行）显示出比手工方法更高效且误差更低的优势。本研究旨在评估手工与自动化ELISA方法在血清半乳糖凝集素-3检测结果上是否存在差异。 方法：首先使用手工ELISA和Ella仪器对115例乳腺癌样本的血清半乳糖凝集素-3水平进行检测。经过变异系数分析和异常值筛选后，对95例样本采用JMP统计软件进行夏皮罗-威尔克检验、斯皮尔曼相关性分析、威尔科克森符号秩检验及回归分析。 结果：Ella仪器检测的变异系数显著降低，证实其比手工ELISA方法更精确可靠。两种方法检测结果呈中等相关性（r=0.49，p<0.0001），但威尔科克森符号秩检验显示Ella仪器测得的血清半乳糖凝集素-3水平显著低于手工ELISA，平均差值为-5.19 ng/mL（p<0.0001）。回归分析表明，随着血清半乳糖凝集素-3水平升高，手工ELISA与Ella检测结果的差异显著增大（p<0.0001）。在不同乳腺癌分期、免疫表型及组织学类型的分层分析中，手工与自动化ELISA技术间的检测差异保持稳定。 结论：尽管Ella仪器是一种快速可靠的检测工具，但在广泛推广使用前，必须重视手工ELISA与Ella仪器在定量血清半乳糖凝集素-3水平时存在的显著差异。
肿瘤(癌症)患者之家