The harmonization process involves the participation of multiple laboratories in a consortium-based iterative testing process to identify the variables crucial for assay performance. Each participating laboratory uses its own reagents, instrumentation, and performs quality control experiments on replicate samples. A central laboratory manages logistics for the proficiency panel, receives raw and analyzed data sets from each participating laboratory, and provides independent central data analysis.
During initial proficiency panels, variables that impact laboratory performance are identifed. Subsequent panels harmonize use of performance-stabilizing variables across laboratories. The outcome of this iterative process is a set of harmonization guidelines, which can be implemented both by the panel participants and by the larger scientific community. Harmonization can be applied to all assay variables from the protocol and raw data acquisition, processing, interpretation, and reporting, so that comparison of data between laboratories becomes objective and supportive of immune biomarker research (van der Burg et al., 2011).
The primary outcome of harmonization is that data sets generated across multiple harmonized laboratories are directly interpretable with regard to test performance. These independent and harmonized data sets from multiple laboratories have facilitated the establishment of assay-specific reference values for background, lower limits of detection, and replicate variation, which serve as community-wide benchmarks for assay performance (Moodie et al., 2012).
From van der Burg et al., (2011) see below.
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