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Further detailed evaluation of methodology and validation of assays can be accepted as supplementary material.
In order to be beneficial at long term, the validation of assays must be performed on a material whose availability will not be interrupted.
This was accomplished by providing the community with two commercially available high-quality human reference RNA samples that can be used as a tool for calibration and quality control as well as for performance assessment and validation of assays.
Because the technical validation of assays for measuring cellular immune biomarkers is not trivial, systematic mono- and multi-center efforts have been initiated in the different fields of cancer immunology, autoimmunity and infectious diseases to harmonize and standardize T cell assays.
Validation of assays is now a requirement for all endpoint parameters in clinical trials [ 30].
Validation of assays and development of standardized data reporting frameworks were mentioned by some as significant obstacles, but other experts felt that such significant progress had been made in those areas that they were no longer major problems, at least for genomic data.
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Appropriate standardization and validation of assaying these potential biomarkers, whether individually or in combinations, are critical, prior to introducing them as clinical determinants, for screening, diagnosis, prognosis, and monitoring for the response of treatment or for recurrence.
Validation of assay precision was demonstrated by repeatability tests (Table 2).
A validation of assay precision, sensitivity, linearity and recovery in rabbit serum was performed according to standard recommendations.
The need to increase the awareness for harmonization initiatives and external validation of assay performance is one of the general common findings of both initiatives.
The strategy used here also attempts to provide a new perspective on how the field of in vitro DT testing may advance with regards to future validation of assay systems.
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