Abstract
BACKGROUND: Technologies such as ELISA, MSD, and Gyrolab have been employed for quantifying protein therapeutics in clinical trials. However, these technologies have limitations with dynamic range often requiring multiple dilution steps, introducing potential errors and variability. RESULTS/METHODOLOGY: A pharmacokinetics assay was successfully developed on the NUcleic acid Linked Immuno-Sandwich Assay (NULISA) platform with a concentration dynamic range exceeding 6 logs. This enabled assessment of all clinical samples across different concentrations with a single dilution, yielding results with good correlation to ELISA and Gyrolab. CONCLUSIONS: NULISA technology offers high sensitivity, full automation, and a wide dynamic range, streamlining assay development and optimization, simplifying sample analysis, minimizing errors, and increasing throughput.