Comparative Analysis of Manual ELISA and Ella, an Automated Instrument for ELISA, in Measuring Serum Galectin-3 Levels in Breast Cancer Patients

Background: Galectin-3 (Gal-3) levels have been indicated as a promising diagnostic, prognostic, and therapeutic target in breast cancer patients. Serum galectin-3 levels are traditionally measured using manual Enzyme-Linked Immunosorbent Assay (ELISA), but recent automated methods, such as ProteinSimple’s SimplePlex assay run on an Ella instrument, have shown promising evidence of being faster and less error-prone than manual methods. This paper aims to assess whether there are differences in serum galectin-3 measurements between automated and manual ELISA methods. Methods: Galectin-3 serum levels were analyzed from one hundred and five breast cancer samples using both manual ELISA and the Ella instrument. JMP was used to perform paired t-tests and regression analyses. Results: The Ella instrument resulted in significantly lower coefficients of variation (CV), confirming that it is more precise and reliable than manual ELISA methods. There was a moderate correlation between ELISA and Ella measurements (r=0.54), but a paired t-test revealed that automated ELISA using Ella resulted in significantly lower galectin-3 levels compared to manual ELISA (p< 0.0001). Regression analysis showed a significant increase in the difference between Ella and manual ELISA measurements as serum galectin-3 levels increase (p< 0.0001). Conclusions: While the Ella instrument is a fast and reliable tool, the discrepancies between manual ELISA and the Ella instrument in quantifying galectin-3 levels are important to address prior to widespread use.