In-depth Evaluation of the Olink Target 48 Cytokine Panel: Inter-Laboratory Evaluation of Performance and Reliability for Biomarker Studies in Oncology.

Olink Target 48 Cytokine (Thermo Fisher Scientific) is a biomarker panel and assay kit frequently used to characterize the pharmacodynamic effects of novel therapeutics and predict treatment outcomes. We have assessed assay performance across four commercial laboratories to determine the consistency of results. Overall reliability of individual biomarkers and the performance of controls were also assessed, and data were used for an exploratory assessment of differential biomarker expression in patients with head and neck cancer or lung cancer, relative to healthy donors. Reproducibility between operators was found to be good for three of the four laboratories, although the median coefficient of variation between operators for laboratory 4 was above the threshold of acceptability (30%) in the first half of the study. Performance across serial dilutions was also good for all laboratories except laboratory 2. Overall, data were statistically concordant for all laboratories except laboratory 4. Olink sample and calibrator controls performed well, and 43 of the 45 biomarkers in the panel were found to have good or moderate reliability. In total, 21 biomarkers were found to be upregulated or downregulated in patients with cancer relative to healthy donors. This comprehensive evaluation supports the use of Olink Target 48 Cytokine for use in biomarker studies and clinical applications, and highlights the need for standardization in sample handling and assay execution across providers.