Table 1.

Advantages and disadvantages of assay standardization versus assay harmonization for early immune biomarker studies

Assay standardizationAssay harmonization
Advantages
• Personnel trained on SOPs• No need for standardized assay protocols
• Lower variability and better interassay comparison through identical reagents, protocols, and analyses• Continuous improvement of assays at all stages of development
• Increased likelihood to support development of validated assays• Process confirms validity of reagents, SOPs, standards, and analysis strategy used by each individual laboratory
• High level of data comparability between successive trials• Benchmarking allows the integration and use of data from multiple institutions
• Facilitates uniform presentation of key procedures and data (MIATA)
• Supported by proficiency panels
Disadvantages
• A single large facility or multiple facilities needed to accommodate different trials• Incremental improvements in performance and negative influences are less likely to be noticed
• Assay validation required for each specific combination of antigens and therapeutic interventions• Standard samples for proficiency panels are not (yet) widely available, allowing only relative benchmarking
• Application only late in development
• Limited flexibility to incorporate new assays
• High costs of running assays
• Sample integrity potentially compromised through shipping
• Potential intellectual property issues
• Low rate of acceptance